U.S. patent application number 14/299500 was filed with the patent office on 2014-09-25 for test apparatus for testing filters or containers.
The applicant listed for this patent is Sartorius Stedim Biotech GmbH. Invention is credited to Martin Dahlberg, Hartmut Langer, Jens Meyer, Sven-Oliver Otto.
Application Number | 20140283924 14/299500 |
Document ID | / |
Family ID | 44786398 |
Filed Date | 2014-09-25 |
United States Patent
Application |
20140283924 |
Kind Code |
A1 |
Dahlberg; Martin ; et
al. |
September 25, 2014 |
TEST APPARATUS FOR TESTING FILTERS OR CONTAINERS
Abstract
A cleaning process is provided for a test apparatus that has a
switch, external connections and internal volumes that can come
into contact with a fluid from a filter to be tested or a container
to be tested. The cleaning process includes selecting one or more
internal volumes to be cleaned, cleaning the selected internal
volumes with a cleaning fluid by a corresponding switching of the
switch, at least partially draining the cleaning fluid left in the
selected internal volumes after cleaning, and flushing the selected
internal volumes with a flushing fluid different from the cleaning
fluid. Also provided are a computer program product for performing
the cleaning process, a cleaning apparatus, and a test apparatus
for testing filters and containers.
Inventors: |
Dahlberg; Martin; (Bovenden,
DE) ; Langer; Hartmut; (Goettingen, DE) ;
Meyer; Jens; (Moringen, DE) ; Otto; Sven-Oliver;
(Goettingen, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sartorius Stedim Biotech GmbH |
Goettingen |
|
DE |
|
|
Family ID: |
44786398 |
Appl. No.: |
14/299500 |
Filed: |
June 9, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13089550 |
Apr 19, 2011 |
|
|
|
14299500 |
|
|
|
|
Current U.S.
Class: |
137/239 |
Current CPC
Class: |
Y10T 137/4252 20150401;
B08B 9/0328 20130101; Y10T 137/8593 20150401; B08B 9/0321 20130101;
B08B 9/032 20130101; B08B 9/0325 20130101 |
Class at
Publication: |
137/239 |
International
Class: |
B08B 9/032 20060101
B08B009/032 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 30, 2010 |
DE |
10 2010 018 881.6 |
Claims
1. A test apparatus (1) for testing filters (5) or containers (7),
comprising: switching means (11, 12, 13, 14, 15); external
connections (21, 23, 25, 27, 29); internal volumes (35, 49, 51, 43,
47, 45, 37, 39, 41, 55, 33, V.sub.11, V.sub.12, V.sub.13, V.sub.14,
V.sub.15), which can come into contact with a fluid from a filter
(5) or container (7) to be tested; wherein the switching means (11,
12, 13, 14, 15) themselves and the switching means (11, 12, 13, 14,
15) and the external connections (21, 23, 25, 27, 29) are
fluidically coupled via the internal volumes (35, 49, 51, 43, 47,
45, 37, 39, 41, 55, 33, V.sub.11, V.sub.12, V.sub.13, V.sub.14,
V.sub.15), and wherein the internal volumes (35, 49, 51, 43, 47,
45, 37, 39, 41, 55, 33, V.sub.11, V.sub.12, V.sub.13, V.sub.14,
V.sub.15) of the test apparatus (1) are arranged such that the
internal volumes (35, 49, 51, 43, 47, 45, 37, 39, 41, 55, 33,
V.sub.11, V.sub.12, V.sub.13, V.sub.14, V.sub.15) can be
substantially completely drained via one of the external
connections (23, 25, 27, 29), which is arranged at the lowest point
with respect to the internal volumes (35, 49, 51, 43, 47, 45, 37,
39, 41, 55, 33, V.sub.11, V.sub.12, V.sub.13, V.sub.14,
V.sub.15).
2. The test apparatus (1) of claim 1, wherein the internal volumes
(35, 49, 51, 43, 47, 45, 37, 39, 41, 55, 33, V.sub.11, V.sub.12,
V.sub.13, V.sub.14, V.sub.15) are arranged such that the path from
the lowest point of the internal volumes (35, 49, 51, 43, 47, 45,
37, 39, 41, 55, 33, V.sub.11, V.sub.12, V.sub.13, V.sub.14,
V.sub.15) to an arbitrary further point within the internal volumes
(35, 49, 51, 43, 47, 45, 37, 39, 41, 55, 33, V.sub.11, V.sub.12,
V.sub.13, V.sub.14, V.sub.15) increases steadily opposite to the
direction of gravity in parts, or has a constant height with
respect to the direction of gravity at least in parts.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application is a divisional application of U.S.
patent application Ser. No. 13/089,550, filed on Apr. 19, 2011, the
contents of which are hereby incorporated by reference in their
entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to a cleaning process for a
test apparatus, a computer program product for performing a
cleaning process according to the invention, a cleaning apparatus,
and a test apparatus for testing filters and/or containers.
[0004] 2. Description of the Related Art
[0005] From document DE 101 36 785 A1 there is known a cleaning
process for a filter test apparatus, in which the filter test
apparatus is filled with a cleaning fluid. After a predetermined
residence time, the contaminated cleaning fluid is flushed out of
the filter test apparatus by means of fresh cleaning fluid.
[0006] Starting from the known prior art, it is an object of the
invention to achieve an improved cleaning result.
[0007] This object is solved by the features of the independent
claims. Preferred embodiments are the subject of the dependent
claims.
SUMMARY OF THE INVENTION
[0008] An aspect of the present invention relates to a cleaning
process for a test apparatus having switching means, external
connections, internal volumes, which can come into contact with a
fluid from a filter to be tested or a container to be tested, the
cleaning process comprising the following steps: [0009] selecting
one or more internal volumes to be cleaned; [0010] cleaning the
selected internal volumes with a cleaning fluid by a corresponding
switching of the switching means; [0011] at least partially
draining the cleaning fluid left in the selected internal volumes
after cleaning; [0012] flushing the selected internal volumes with
a flushing fluid different from the cleaning fluid.
[0013] Advantageously, the process according to the invention leads
to an improved cleaning of the internal volumes, particularly from
the microbiological point of view. Advantageously, the cleaning
fluid, which is contaminated itself during cleaning of the internal
volumes, is prevented either from accumulating or remaining in the
internal volumes of the test apparatus or from mixing with the
subsequently supplied cleaning fluid or flushing fluid.
Particularly in the case that the contaminations of the internal
volumes contain bacteria or viruses, it is necessary to completely
remove both the contaminations and the contaminated cleaning fluid
from the internal volumes of the test apparatus before the test
apparatus is put into normal operation again. Moreover, the
cleaning process according to the invention can be performed more
easily and more safely than cleaning processes known so far.
[0014] In the cleaning process according to the invention, which is
particularly computer-assisted or computer-controlled, the internal
volumes to be cleaned can be selected particularly by switching of
the switching means, and particularly all or substantially all
internal volumes that can come into contact with a fluid during
normal operation of the test apparatus can be cleaned. It is
therefore possible to clean internal volumes having been
contaminated or soiled by a fluid from an apparatus to be tested.
Such an apparatus to be tested can be a filter apparatus or a
container.
[0015] The cleaning fluid can comprise a detergent, such as dilute
or concentrated sodium hydroxide solution. Particularly, the
cleaning fluid can consist of a NaOH solution (sodium hydroxide
solution or caustic soda lye) with a concentration of approx. 0.1
mol to approx. 2 mol, preferably of approx. 0.1 mol. A further
preferred cleaning fluid is a H.sub.2O.sub.2 solution from approx.
0.33% to approx. 1%, preferably of approx. 1.0% (hydrogen peroxide
solution). Preferably, the cleaning fluid can comprise a solvent,
particularly an alcoholic solution or a surfactant solution. The
term "fluid" as defined by the present application comprises a
liquid phase, a gaseous phase, as well as a mixture thereof.
Preferably, approx. 5 to 30 liters of cleaning fluid, further
preferably approx. 6 liters, are required to clean the internal
volumes.
[0016] The partial drainage of the cleaning fluid is performed by a
corresponding switching of the switching means, wherein the
cleaning fluid is removed from the internal volumes of the test
apparatus at least partially, preferably substantially completely.
A substantially complete drainage of the cleaning fluid means that
the quantity of cleaning fluid remaining in the internal volumes is
preferably smaller than approx. 5%, further preferably smaller than
approx. 2%, particularly smaller than approx. 1% of the internal
volumes of the test apparatus to be cleaned. The drainage is
preferably performed in a successive manner, i.e. after the
cleaning fluid has remained for a predetermined residence time
after the filling of the internal volumes. The residence time may
be more than approx. 10 minutes, preferably more than approx. 20
minutes, particularly approx. 60 minutes. Thus, the supplied
cleaning fluid can take effect in the internal volumes to be
cleaned. The contaminations can be soaked or partially dissolved to
remove them from the wall surface of the internal volumes to be
cleaned. The drainage may start after the residence time has
expired.
[0017] Flushing of the selected internal volumes with the flushing
fluid advantageously causes the remaining quantity of cleaning
fluid to be diluted by the flushing fluid and to be substantially
completely flushed or carried out of the internal volumes. The
flushing fluid is different from the cleaning fluid. The flushing
fluid preferably consists of demineralized, preferably sterile
water or ultrapure water. Flushing can be performed with a
predetermined flushing time of approx. 10 to 50 minutes.
Preferably, approx. 5 to 30 liters of flushing fluid are required
to flush the internal volumes.
[0018] Preferably, cleaning with the cleaning fluid, draining
and/or flushing with the flushing fluid are substantially performed
successively. By successively cleaning, draining and/or flushing
the internal volumes to be cleaned, a comprehensive cleaning of the
internal volumes to be cleaned can be ensured. Moreover, by
successively draining and/or flushing the cleaning fluid off the
internal volumes, it can be safely ensured that substantially no
cleaning fluid is left in the respective internal volume
afterwards. Particularly if harmful and/or irritant and/or
corrosive cleaning fluids are used, it can be advantageously
ensured that residues of the cleaning fluid do not inadvertently
contaminate one of the filters or containers to be tested when the
test apparatus is used. Preferably, the cleaning process comprises
a further step of at least partially draining the flushing fluid
left in the flushed internal volumes after flushing.
[0019] For the selection of the internal volumes to be cleaned,
drained or flushed, the cleaning process preferably comprises at
least one step of pneumatically and/or electrically switching the
switching means.
[0020] Preferably, the step of draining the flushing fluid off the
cleaned and flushed internal volumes is performed substantially
successively by correspondingly switching the switching means.
Preferably, the step of draining the flushing fluid and drying the
internal volumes is performed by means of sterile compressed air or
by means of a pressurized gas, particularly of an inert gas, with a
pressure of greater than 100 kPa (1 bar), further preferably with a
pressure of greater than 200 kPa (2 bar), most preferably 200 kPa
(2 bar).
[0021] By drying the cleaned and flushed internal volume
(preferably with compressed air), it is ensured that substantially
no cleaning fluid and/or flushing fluid is left in the cleaned
internal volumes.
[0022] Preferably, the cleaning process comprises the step of:
[0023] cleaning the selected internal volumes by having a vaporous
or gaseous cleaning fluid flow through the selected internal
volumes by a corresponding switching of the switching means.
[0024] Particularly preferably, the cleaning fluid in this case
comprises hot steam having a temperature of greater than approx.
121.degree. C., preferably greater than approx. 134.degree. C.
Advantageously, the selected internal volumes can be sterilized by
this step. Further preferably, the step of sterilizing using hot
steam is performed after the flushing fluid has been drained off
the internal volumes or after the selected internal volumes have
substantially fallen dry. Further preferably, the sterilization
with the vaporous or gaseous cleaning fluid can be followed by
drainage of the cleaning fluid, particularly by means of a sterile
gas, for example sterile compressed air.
[0025] An aspect of the present invention relates to a particularly
computer-assisted or computer-controlled cleaning process for a
test apparatus having switching means, external connections,
internal volumes, which can come into contact with a fluid from an
apparatus to be tested, the cleaning process comprising the
following steps: [0026] selecting one or more internal volumes to
be cleaned; [0027] cleaning the selected internal volumes by having
a vaporous or gaseous cleaning fluid flow through the selected
internal volumes by a corresponding switching of the switching
means; [0028] draining the cleaning fluid left in the selected
internal volumes after cleaning.
[0029] The cleaning fluid may be vaporous or gaseous. To prevent
the cleaning fluid from condensing within the internal volumes, the
flow of the cleaning fluid through the selected internal volumes is
enabled by a corresponding switching of the switching means.
Accordingly, a supply of cleaning fluid into and drainage of the
cleaning fluid off the selected internal volumes take place at the
same time. Advantageously, if a vaporous or gaseous cleaning fluid
is used, the quantity of the cleaning fluid left in the internal
volumes is limited to the proportion of cleaning fluid condensed in
the internal volumes. Further advantageously, no flushing of the
internal volumes by means of a flushing fluid is necessary for a
low degree of condensation. For example, ozone may be used as a
gaseous cleaning fluid, which allows safely killing microbiological
organisms and substantially does not accumulate or remain within
the internal volumes of the test apparatus. Preferably, draining of
the cleaning fluid off the internal volumes can be followed by
flushing, preferably with a flushing fluid different from the
cleaning fluid. If a vaporous or gaseous cleaning fluid is used,
flushing can also be performed with the liquid phase of the
cleaning fluid as the flushing fluid.
[0030] Preferably, the cleaning fluid is a hot steam having a
temperature of greater than approx. 121.degree. C., preferably
greater than approx. 134.degree. C. Due to the preferred use of hot
water vapor, the hot steam has a positive pressure of approx. 100
kPa (approx. 1 bar) and a positive pressure of approx. 200 kPa
(approx. 2 bar) at a temperature of approx. 121.degree. C. and a
temperature of approx. 134.degree. C., respectively.
[0031] Further preferably, the hot steam is generated from
demineralized water. Advantageously, the cleaning fluid condenses
to pure water within the selected internal volumes, so that
flushing with a flushing fluid is usually not required. Preferably,
however, flushing with a flushing fluid, for example demineralized
water, can be performed. According to the invention, hot steam and
water are considered to be mutually different fluids. To also
achieve a sterilization of the internal volumes in addition to the
cleaning, the hot steam is preferably supplied such that the
temperature within the internal volumes is at least 121.degree. C.
at any point. In order to monitor that this temperature is
maintained, a temperature sensor is preferably provided at a point
of the internal volumes which has the substantially greatest heat
absorption capacity and thus probably the lowest temperature during
cleaning with hot steam. This point can preferably be in the region
of a cleaning fluid outlet. Further preferably, particularly for
configurations of the internal volumes in which the cleaning fluid
outlet is not the coldest point within the internal volumes, for
example if the outlet is arranged close to the inlet and the inlet
temperature is quickly reached by heat conduction at the outlet,
the temperature sensor can preferably be arranged in
difficult-to-access regions in or at which fluid has accumulated,
as the case may be.
[0032] Preferably, the step of draining the cleaning fluid and/or
the flushing fluid comprises a step of at least partially drying
the cleaned and/or flushed internal volumes. Draining can be
performed by a corresponding switching of the switching means.
[0033] Preferably, the step of drying is performed using compressed
air, preferably using sterile compressed air. Preferably, the
compressed air has a positive pressure of at least approx. 100 kPa
(1 bar) with respect to the atmospheric pressure, further
preferably a pressure of greater than 200 kPa (2 bar), particularly
preferably 200 kPa (2 bar). The step of drying of the cleaned or
flushed internal volumes is performed preferably substantially
successively by a corresponding switching of the switching means.
By drying of the cleaned or flushed internal volumes, it is ensured
that substantially no cleaning fluid or no flushing fluid is left
in the cleaned or flushed internal volumes.
[0034] Preferably, the cleaning process further comprises the steps
of: [0035] collecting the cleaning fluid and/or flushing fluid
exiting the selected internal volumes; [0036] separating the
collected cleaning fluid and/or the flushing fluid into a liquid
phase and a gaseous phase, wherein the liquid phase is collected in
an receiving container, and the gaseous phase escapes into the
environment.
[0037] Collecting of the cleaning fluid and/or flushing fluid
exiting the test apparatus during cleaning and/or draining is
preferably performed by means of at least one fluid discharge line,
which guides the exiting fluids to a collecting apparatus. The
collecting apparatus can comprise a collecting container, in which
the exiting and optionally contaminated fluids are collected. The
collecting container is preferably formed as a so-called "sterile
receiver", so that a sterile fluidic connection between the test
apparatus, the cleaning apparatus, and the collecting container can
be established. Due to the quantity of the required cleaning fluid
or flushing fluid, the collecting container preferably has a
volumetric capacity of more than approx. 10 liters, further
preferably of more than approx. 20 liters, and particularly of more
than approx. 60 liters. Preferably, the collecting container has at
least one check valve, which prevents fluids from escaping from the
collecting container toward the test apparatus or into the
environment through the connected at least one fluid discharge
line. If a vaporous or gaseous cleaning fluid or flushing fluid is
used, the fluid supplied to the collecting apparatus is separated
into a liquid phase and a gaseous phase, usually by condensation
e.g. on a cooling element, a cooling coil, etc. The gaseous phase
can escape into the environment via a valve, for example a pressure
relief valve or a check valve.
[0038] Preferably, the gaseous phase escapes via a
bacteria-retaining apparatus and/or via a virus-retaining
apparatus. Particularly if the internal volumes of the test
apparatus are contaminated with pathogenic germs and thus the
cleaning fluid and/or the flushing fluid might contain pathogenic
germs as well, the bacteria-retaining apparatus and/or the
virus-retaining apparatus prevents these germs from escaping or
exiting into the environment.
[0039] Preferably, the cleaning process comprises the step of
logging the course of the cleaning process, for example by storage
on a data carrier, by generating a printout of a cleaning protocol,
or by transmitting the cleaning protocol over a data line.
Computer Program Product
[0040] An aspect of the present invention relates to a computer
program product, particularly embodied as a signal and/or as a data
stream, comprising computer-readable instructions, wherein the
instructions perform a process according to the invention when
loaded and executed on a suitable computer system. In other words,
a computer program product is provided which comprises program
parts for performing the process according to the invention or a
preferred embodiment thereof. Further, a computer program is
provided which, when loaded on a computer, can perform the process
according to the invention or a preferred embodiment thereof.
Further, a computer-readable storage medium is provided on which
such a computer program is stored.
Cleaning Apparatus
[0041] An aspect of the present invention relates to a cleaning
apparatus for a test apparatus, comprising: [0042] at least one
fluid connection for a container for a cleaning fluid, wherein the
fluid connection is fluidically coupled with a complementary or
mating connection via a fluid supply line, wherein the
complementary connection can be fluidically coupled with an
external connection of the test apparatus, and [0043] at least one
fluid connection for a container for a flushing fluid, wherein the
fluid connection is fluidically connected with the complementary
connection via a fluid supply line; [0044] at least one apparatus
for delivering a cleaning fluid and/or a flushing fluid from one of
the containers to the complementary connection; and [0045] at least
one connection for a collecting apparatus for collecting the
cleaning fluid and/or flushing fluid exiting the test apparatus,
wherein the collecting apparatus can be coupled with at least one
external connection of the test apparatus by means of at least one
fluid discharge line.
[0046] Advantageously, the cleaning apparatus can be handled more
easily and safely and achieves an improved cleaning of the test
apparatus. The cleaning apparatus comprises at least one fluid
connection, preferably two fluid connections, for a cleaning fluid
container and a flushing fluid container. It is understood that in
addition to or instead of the fluid connections for the containers,
the cleaning apparatus can also comprise the containers themselves.
The corresponding fluid connections would then be internal fluid
connections, which fluidically couple the cleaning fluid container
and the flushing fluid container with the associated fluid supply
lines. The fluid supply line is fluidically connected with the
complementary connection, which can preferably be formed as a
complementary plug-in nipple or a complementary plug-in coupling,
which can be fluidically connected with an associated plug-in
coupling or an associated plug-in nipple of one of the external
connections of the test apparatus. It is understood that for
practical purposes, a cleaning fluid container and a flushing fluid
container are connected with an associated fluid connection at the
beginning of the cleaning process to advantageously perform the
entire cleaning process without decoupling or coupling fluid lines
or fluid connections. However, merely a single fluid connection can
be provided, which sequentially serves as a fluid connection for
the cleaning fluid container and then as a fluid connection for the
flushing fluid container, wherein while the cleaning process is
performed, the cleaning fluid container has to be separated from
the fluid connection to subsequently connect the flushing fluid
container thereto.
[0047] The at least one apparatus for delivering the cleaning fluid
and/or the flushing fluid is preferably designed or configured such
as to deliver both the cleaning fluid and the flushing fluid from
the corresponding container to the complementary connection of the
cleaning apparatus and further via the external connection coupled
therewith into the internal volumes of the test apparatus to be
cleaned. Preferably, two delivering apparatuses can be provided,
wherein the first delivering apparatus is designed to deliver the
cleaning fluid, and the second delivering apparatus is designed to
deliver the flushing fluid. The at least one delivering apparatus
can be configured as a pump, particularly as a flexible-tube
pump.
[0048] The cleaning apparatus comprises at least one connection for
a collecting apparatus, or preferably the collecting apparatus
itself, wherein the connection for the collecting apparatus then is
an internal connection of the cleaning apparatus. The collecting
apparatus can comprise a collecting container for collecting the
cleaning fluid or flushing fluid exiting the test apparatus,
wherein the collecting apparatus or the collecting container is
coupled with an external connection or multiple external
connections of the test apparatus via one or more fluid discharge
line(s) during normal operation.
[0049] Preferably, the cleaning apparatus comprises at least one
switching means controlling the fluid flow through one of the fluid
supply lines and/or controlling the fluid flow through one of the
at least one fluid discharge lines. Further preferably, the
switching means comprise pneumatic switching means and/or
electromagnetic switching means. For example, the switching means
can be configured as valves, i.e. switching valves or proportional
valves, which can be actuated electrically, electromagnetically
and/or pneumatically. Preferably, the valves used, e.g. bellows or
diaphragm valves, have a small valve volume of preferably less than
approx. 10 ml, particularly of less than approx. 1 ml.
Particularly, the switching means can be computer-controlled, so
that the switching operations for initiating different steps of the
cleaning process are advantageously performed automatically, i.e.
without any user action or user interaction.
[0050] Preferably, the apparatus for delivering the cleaning fluid
and/or the flushing fluid can be operated with compressed air or
pressurized gas. Particularly, the delivery is performed by
pressurizing the container for cleaning fluid or the container for
flushing fluid. Due to the positive pressure in the container(s),
the fluid contained therein can be delivered via a rising pipe.
[0051] An aspect of the present invention relates to a cleaning
apparatus for a test apparatus, comprising: [0052] an apparatus for
providing a vaporous or gaseous cleaning fluid, which can be
coupled with an external connection of the test apparatus by means
of a cleaning fluid supply line; [0053] at least one connection for
a separating apparatus for separating the cleaning fluid exiting
the test apparatus into a liquid phase and a gaseous phase, wherein
the separating apparatus can be coupled with at least one external
connection of the test apparatus by means of a fluid discharge
line, and wherein the liquid phase arising in the separating
apparatus is collectable in a collecting container, and the gaseous
phase arising in the separating apparatus escapes into the
environment.
[0054] The apparatus for providing a vaporous or gaseous cleaning
fluid can preferably comprise an apparatus for producing the
vaporous or gaseous cleaning fluid. Moreover, alternatively or in
addition to the connection for the separating apparatus, the
cleaning apparatus can also comprise the separating apparatus
itself. A preferred separating apparatus is a condensation
apparatus, such as a cooling element or a cooling coil. The liquid
phase arising in the separating apparatus can be collected in a
collecting container. Preferably, the collecting container has at
least one check valve, so that no fluids from the collecting
container can get back into the test apparatus. The gaseous phase
can escape into the environment preferably via a valve, for example
a pressure relief valve or a check valve, optionally via a filter,
a bacteria-retaining apparatus and/or a virus-retaining
apparatus.
[0055] Preferably, the apparatus for providing the cleaning fluid
comprises a hot steam generator generating a hot steam having a
temperature of greater than approx. 121.degree. C. Further
preferably, the hot steam is generated from demineralized water.
Due to the preferred use of hot water vapor, the hot steam has a
positive pressure of approx. 100 kPa (>1 bar) at a temperature
of greater than approx. 121.degree. C. At a further preferred
temperature of greater than approx. 134.degree. C., the positive
pressure is greater than approx. 200 kPa (>2 bar). In order to
monitor that the preferred minimum temperature of approx.
120.degree. C. is maintained when sterilizing the internal volumes,
preferably at least one temperature sensor and/or at least one
pressure sensor is/are provided within the internal volumes.
Preferably, at least one of the temperature and/or at least one of
the pressure sensors is arranged in the region of a cleaning fluid
outlet.
[0056] Preferably, the cleaning apparatus comprises a
bacteria-retaining apparatus and/or a virus-retaining apparatus,
via which the gaseous phase escapes into the environment.
[0057] Preferably, the cleaning apparatus comprises an apparatus
for providing compressed air, preferably sterile compressed air,
wherein the compressed air can be supplied to the compressed air
supply connection of the test apparatus via a compressed air supply
line connection. The compressed air can be used to deliver fluids
within the cleaning apparatus and/or the test apparatus connected
therewith. Moreover, at least one external connection of the test
apparatus is configured such that a compressed air supply line for
drying the cleaned or flushed internal volumes is connectable
therewith. Thus, drying of the cleaned internal volumes can be
performed with compressed air having a suitable pressure,
preferably a positive pressure of greater than approx. 100 kPa
(>1 bar), further preferably a pressure of greater than 200 kPa
(2 bar), particularly preferably 200 kPa (2 bar). Particularly, the
compressed air can be supplied to the test apparatus via a
compressed air supply line connection of the cleaning
apparatus.
[0058] Preferably, the apparatus for providing compressed air is
pneumatically coupled with the apparatus for delivering the
cleaning fluid and/or the flushing fluid. Further preferably, the
apparatus for providing compressed air is coupled with
pneumatically actuatable switching means of the cleaning apparatus.
Advantageously, an additional delivering apparatus for the cleaning
fluid or for the flushing fluid, such as an internal or internal
pump, can be omitted. By omitting an external pump, the safety in
performing the cleaning process is advantageously increased, since
fluid couplings or tubes are prevented from coming off.
Particularly if a corrosive cleaning fluid is used, the risk of
work accidents can be reduced.
[0059] Preferably, the cleaning apparatus comprises a connection
device comprising at least two complementary or mating external
connections of the cleaning apparatus. The compressed air supply
line connection, the complementary connection for supplying the
cleaning or the flushing fluid, the at least one fluid discharge
connection, and the compressed air connection can be part of a
connection device as complementary external connections of the
cleaning apparatus, which are configured complementarily to the
corresponding external connections of the test apparatus. The
connection device can preferably cause the geometric distances of
the individual, complementary external connections to remain
constant to each other. In other words, the individual,
complementary external connections are spatially fixed or fixable
with respect to each other. Preferably, the connection device can
be arranged on the test apparatus by a displacement movement such
that the complementary external connections of the connection
device can substantially simultaneously be coupled with the
associated external connections of the test apparatus.
Advantageously, the required connections can be established more
quickly, wherein erroneous coupling of the individual connections
is prevented in addition. Further preferably, the work safety
during the process is increased, since fluid couplings or tubes are
prevented from coming off.
[0060] Further preferably, the connection device comprises a
connector of the cleaning apparatus, which is configured to be
electrically coupled with a mating complementary connector of the
test apparatus. Preferably, electrical coupling can be performed by
displacing the cleaning apparatus along a connection direction A,
particularly by a linear displacement. Particularly, the connector
or the connection device can be designed or configured for an
interface, for example a RS232 interface, a RS435 interface, a RJ45
interface, and/or a USB interface. Further preferably, the
connection device can have a connector for the electric power
supply of the cleaning apparatus via the test apparatus.
Advantageously, a power supply in the cleaning apparatus can be
omitted then.
Test Apparatus
[0061] An aspect of the present invention relates to a test
apparatus for testing filters and/or containers, comprising: [0062]
switching means; [0063] external connections; [0064] internal
volumes, which can come into contact with a fluid from a filter or
container to be tested; wherein the switching means themselves and
the switching means and the external connections are fluidically
coupled via the internal volumes, and wherein the internal volumes
of the test apparatus are arranged such that the internal volumes
can be substantially completely drained via one of the external
connections, which is arranged at the lowest point with respect to
the internal volumes.
[0065] Advantageously, the test apparatus can be handled more
easily and safely and particularly be cleaned more easily and
better. Preferably, the switching means of the test apparatus
comprise pneumatic switching means and/or electromagnetic switching
means. For example, the switching means can be configured as
valves, i.e. switching valves or proportional valves, which can be
actuated electrically, electromagnetically and/or pneumatically.
Preferably, the valves used, e.g. bellows or diaphragm valves, have
a small valve volume of preferably less than approx. 10 ml,
particularly of less than approx. 1 ml. Particularly, the switching
means can be computer-controlled, so that the switching operations
for initiating different steps of the cleaning process are
advantageously performed automatically, i.e. without any user
action.
[0066] At least one external connection is configured such that a
cleaning fluid or a flushing fluid can be supplied to the test
apparatus thereby in order to clean selected internal volumes.
Thus, the cleaning apparatus can be coupled with the test apparatus
to be cleaned in an easy and safe manner. Furthermore, at least one
external connection is configured such that the supplied cleaning
fluid or flushing fluid can be discharged or removed thereby.
[0067] Further preferably, at least one of the external connections
is configured such that a source of compressed air for drying the
cleaned or flushed internal volumes can be coupled therewith. Thus,
drying of the cleaned internal volumes can be performed using
compressed air.
[0068] The internal volumes can comprise coupling lines between the
switching means, coupling lines between the switching means and the
external connections, volumes in the switching means, preferably an
internal reference tank, and coupling lines between the internal
reference tank and at least one switching means or at least one
external connection. Preferably, the internal volumes are defined
from parts and/or lines comprising walls of stainless steel and/or
Teflon.
[0069] Particularly, the switching means, the coupling lines, and
the external connections, which define the internal volumes, can be
drained substantially completely. Particularly, in normal
operation, the coupling lines are sloped with respect to the
horizontal defined by the field of gravity of the earth, preferably
at an angle of greater than approx. 1 degree, further preferably
greater than approx. 5 degrees.
[0070] One of the external connections is arranged at the lowest
point with respect to the internal volumes during normal operation
of the test apparatus to enable a substantially complete drainage
of the internal volumes via this external connection.
[0071] Preferably, the internal volumes are arranged such that the
path from the lowest point of the internal volumes to an arbitrary
further point within the internal volumes increases steadily
opposite to the direction of gravity in parts, or has a constant
height with respect to the direction of gravity at least in
parts.
[0072] Preferred embodiments of the present invention will be
explained in the following by way of example on the basis of the
accompanying drawings. Individual features of the illustrated
preferred embodiments can be combined to further preferred
embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0073] FIG. 1 a schematic structure of a preferred embodiment of a
test apparatus for testing filters and/or sterile disposable
containers.
[0074] FIG. 2 a schematic structure of a preferred embodiment of a
cleaning apparatus for a test apparatus for testing filters and/or
sterile disposable containers.
[0075] FIG. 3 a flow diagram of a preferred cleaning process.
[0076] FIG. 4 a schematic structure of the embodiment of the
cleaning apparatus during a drying step.
[0077] FIG. 5 a schematic structure of a preferred embodiment of a
cleaning apparatus for a test apparatus.
[0078] FIG. 6 a flow diagram of a preferred cleaning process.
[0079] FIG. 7a a perspective view of a preferred embodiment of a
test apparatus.
[0080] FIG. 7b a side view of the preferred embodiment of the test
apparatus.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0081] FIG. 1 shows a schematic structure of a preferred embodiment
of a test apparatus 1 for testing filters 5 or for testing the
pressure tightness of containers 7, particularly sterile disposable
containers.
[0082] The test apparatus 1 comprises valves 11, 12, 13, 14, 15,
which are particularly designed as switching valves, and at least
one proportional valve 16. Furthermore, the test apparatus 1
comprises external connections 21, 23, 25, 27, 29, wherein the
external connections comprise a compressed air supply connection
21, through which compressed air is supplied during the test
operation, a connection 23 for internal ventilation, a connection
25 for external ventilation, a test connection 27 for connection of
an apparatus to be tested, for example a filter 5 to be tested or a
filter apparatus to be tested or a container 7 to be tested, and a
connection 29 for an external reference tank 31. Preferably, an
internal reference tank 33 is provided in the test apparatus 1. The
valves 11, 12, 13, 14, are fluidically coupled with each other via
coupling lines 35, 37, 39, 41, i.e. a fluid can flow from one of
the switching valves 11, 12, 13, 14, 15 to another one through the
coupling lines 35, 37, 39, 41. Furthermore, the valves 11, 12, 13,
14, 15 are fluidically coupled with the respective mating external
connections 23, 25, 27 via coupling lines 43, 47, 45. The internal
reference tank 33 is coupled with the valve 12 via a coupling line
49, and hydraulically coupled or fluidically coupled with the
connection 29 for the external reference tank 31 via a coupling
line 51. Furthermore, the test apparatus 1 preferably comprises a
pressure gauge 53, which is hydraulically coupled or fluidically
coupled with the coupling line 35 via a coupling line 55.
[0083] The valves 11, 12, 13, 14, 15 are preferably bellows or
diaphragm valves and preferably have a small valve volume V.sub.11,
V.sub.12, V.sub.13, V.sub.14, V.sub.15, for example a valve volume
of less than approx. 5 ml, preferably of less than approx. 1
ml.
[0084] The coupling lines 35, 49, 51, 43, 47, 45, 37, 39, 41, 55,
the internal reference tank 33, and the internal volumes V.sub.11,
V.sub.12, V.sub.13, V.sub.14, V.sub.15 of the valves 11, 12, 13,
14, 15 will be referred to as internal volumes in the following.
Furthermore, the following exemplary description of a preferred
embodiment of the present invention is made with respect to a test
apparatus 1 comprising only one proportional valve 16.
[0085] During the testing of for example a filter 5, e.g. a
membrane filter, the internal reference tank 33 is filled with
compressed air having a predetermined or predeterminable pressure.
This may be done via the external reference tank 31 or via the
compressed air supply connection 21 and the proportional valve 16.
During a subsequent measurement, it is determined by means of the
reference tank 33 and the pressure gauge 53 how large the pressure
drop in the filter 5 is. Since the pressure drop depends on the
degree of clogging of the continuous filter membrane pore space,
the quality of the filter 5 can thus be determined. In the same or
similar way, the pressure tightness of containers 7, particularly
sterile disposable containers 7 and sterile flexible bags 7, can be
tested. To this end, for example a flexible sterile disposable bag
7 can be arranged between two holding elements 9, which allow the
inflation of the disposable bag 7 due to pressurization only to a
predetermined or predeterminable volume. If the detected pressure
drop after the inflation of the disposable bag 7 is below a
predetermined or predeterminable threshold value, the disposable
bag is sufficiently tight or is considered to be sufficiently
tight.
[0086] As part of the test, the filter 5 to be tested or the filter
device to be tested or the container 7 to be tested preferably is
to be validated as well, i.e. the quality of the filter 5 is to be
determined on the basis of predetermined or predeterminable
standards. To this end, the test apparatus 1 is preferably
connected to the soiled side of the filter 5, i.e. the side to
which a fluid to be filtered is supplied during normal operation.
However, during the test it may happen that the unfiltered and thus
soiled fluid enters the test apparatus 1, in particular its
internal volumes, due to a backflow. However, for a validatable
testing, it is necessary to ensure that the test apparatus 1 is not
contaminated, e.g. with bacteria, viruses, and other
contaminations, before each new test process. It is thus required
to thoroughly clean the test apparatus 1 preferably before each
test process. To further allow an even safer cleaning, the internal
volumes are preferably defined by parts or lines that are
substantially completely made of stainless steel or a FDA-conform
material (FDA: US Food and Drug Administration), for example
Teflon.
[0087] Furthermore, to prevent fluid from remaining in the internal
volumes of the test apparatus 1 or to keep it as little as
possible, the internal volumes are preferably arranged according to
a hygienic design.
[0088] The term "hygienic design" means that the test apparatus can
be kept substantially free from vegetative microorganisms, wherein
it can be defined thereby that the microbiological failure rate
remains within predetermined or predeterminable limits. A
predominant pathogen may be Aspergillus niger, a mold fungus, which
is capable of decomposing all organic materials and even glass.
Aspergillus niger is often used in the food industry to produce
citric acid. The fungus tolerates pH ranges from 1.5 to 9.8 and is
thus capable of existing both in strongly acidic and alkaline
milieus. The cleaning process, the cleaning apparatus and/or the
test apparatus are preferably designed such that a contamination
with this predominant pathogen is substantially completely
removed.
[0089] In other words, the internal volumes are arranged such that
a substantially complete drainage of the internal volumes is
possible via one of the external connections 23, 25, 27, 29. To
this end, preferably one of the external connections 23, 25, 27, 29
is arranged such that it is located at the lowest point with
respect to the internal volumes during normal operation of the test
apparatus 1. Moreover, preferably all further internal volumes are
arranged such that the path from the lowest point of the internal
volumes to an arbitrary further point within the internal volumes
rises steadily in parts opposite to the direction of gravity or has
at least a constant height in parts opposite to the direction of
gravity. Thus, it is ensured that fluid-filled internal volumes can
be drained via an external connection 23, 25, 27, 29 due to the
effect of gravity on the fluid.
[0090] Further preferably, the internal volumes can be drained by
means of compressed air or by means of gas with excess pressure
(particularly inert gas), which is provided at the compressed air
supply connection 21. Particularly preferably, the drainage in the
embodiment shown in FIG. 1 can then be performed via the test
connection 27. To ensure a substantially complete drainage of the
internal volumes in this case, the dead volumes, i.e. the internal
volumes, which are substantially not flown through by compressed
air over the path from the compressed air supply connection 21 to
the test connection 27, are minimized, particularly preferably
zero. In particular, the dead volume of the coupling line 37 is
minimized, particularly substantially zero. The term substantially
zero particularly means that the line length of the coupling line
37 between the valve 12 and the coupling line 35 is smaller or
shorter than the diameter of the coupling line 37, particularly
smaller than approx. 1 mm. Thereby, it is advantageously prevented
that fluid remains in the coupling line 37 during draining of the
internal volumes, for example due to capillary forces. Preferably,
the dead volume of the coupling line 55 between the pressure gauge
53 and the coupling line 35 is also substantially zero.
[0091] The drainage of the internal volumes can alternatively or in
addition be performed via the connection 29 for an external
reference tank. Advantageously, the connection 29 can represent the
highest point in the fluidically interconnected system of the
internal volumes as a rule.
[0092] FIG. 2 shows the schematic structure of a preferred
embodiment of a cleaning apparatus 3 for a test apparatus 1 for
testing filters and/or sterile disposable containers. The cleaning
apparatus 3 can comprise a fluid connection 57 and preferably a
compressed air connection 59 for a pressure container 61, wherein
the pressure container 61 contains a cleaning fluid 63 or a
flushing fluid 65 during normal operation. Preferably, as is shown
in FIG. 2, the fluid connection 57 or the compressed air connection
59 may also be connections of external lines located outside a
preferred housing 4 of the cleaning apparatus 3. The pressure
container 61 comprises a compressed air intake 67, which can be
coupled with the compressed air connection 59, and a fluid exit 69,
which can be coupled with the fluid connection 57, wherein a riser
tube 71 is fluidically coupled with the fluid exit 69. The riser
tube 71 preferably extends down to the bottom of the pressure
container 61. If the pressure container 61 is fed with compressed
air via the compressed air intake 67, excess pressure builds up
within the pressure container 61, due to which the cleaning fluid
63 or flushing fluid 65 contained in the pressure container 61
rises within the riser tube to escape from the pressure container
61 through the fluid exit 69.
[0093] For the normal operation of the cleaning apparatus 3, the
fluid exit 69 of the pressure container 61 can be fluidically
coupled with one of the external connections 23, 25, 27, 29 of the
test apparatus 1 via the fluid connection 57 and a fluid supply
line 73, wherein the connection can preferably be established by
means of a complementary connection 75, for example by means of a
plug-in nipple or a plug-in coupling. The fluid supply line 73 can
be formed as an external line. Alternatively, the fluid connection
57 and the complementary connection 75 can be arranged or formed on
or in the housing 4 of the cleaning apparatus 3, so that the fluid
supply line 73 is arranged within the housing 4 of the cleaning
apparatus 3. Preferably, the cleaning apparatus 3 has a temperature
and/or a pressure sensor (not shown), which is/are thermally and/or
fluidically coupled with the external connection 23, 25, 27, 29 of
the test apparatus 1 in order to detect the temperature and/or the
pressure of the supplied cleaning fluid 63. Particularly, the
pressure sensor can be fluidically coupled with the fluid supply
line 73, wherein the fluid supply line 73 is preferably arranged
within the housing 4 of the cleaning apparatus 3. In order to
supply compressed air to the pressure container 61, the compressed
air intake 67 of the pressure container 61 can be connected with a
compressed air source 77. Preferably, the compressed air intake 67
of the pressure container 61 is fluidically coupled with the
compressed air source 77 via a compressed air supply line 79, a
pressure reducer 81, and a compressed air valve 82. As is shown,
the compressed air line 79 may be an external line having a
compressed air inlet 85, which can be coupled with a compressed air
outlet 86 of the pressure valve 82. Alternatively, the compressed
air line 79 can be arranged within the housing 4 of the cleaning
apparatus 3, wherein then particularly the compressed air
connection 59 is also arranged in or on the housing, and
particularly the compressed air inlet 85 and the compressed air
outlet 86 may be internal connections within the housing 4.
Alternatively or in addition to the pressure reducer 81, the
pressure reduction can be performed by means of reducing the cross
section of the compressed air line 79. Particularly, the compressed
air source 77 can be the same compressed air source 77 that
provides the compressed air at the compressed air supply connection
21 of the test apparatus 1. Here, a T-connection 83 can be arranged
between the compressed air source 77 and the compressed air supply
connection 21, so that the compressed air supply connection 21 and
the compressed air intake 67 together are fluidically coupled with
the pressure source 77. It is understood that both the pressure
reducer 81 and the T-connection 83 can be part of the cleaning
apparatus 3, i.e. for example can be arranged at least partially in
the housing 4 with other components of the cleaning apparatus 3. In
this case, the cleaning apparatus 3 preferably has a primary
compressed air inlet, which can be fluidically coupled with the
compressed air source 77, and a compressed air supply line
connection 84, which can be fluidically coupled with the compressed
air supply connection 21 of the test apparatus 1. Preferably, the
housing 4 of the cleaning apparatus 3 can have a compressed air
outlet 86 to which an external compressed air supply connection 79
can be coupled. Alternatively, the pressure reducer 81 and/or the
T-connection 83 can be designed as external components, wherein the
compressed air is supplied to the compressed air inlet 85 of the
cleaning apparatus 3 or the compressed air inlet 85 of the
compressed air supply line 79 in a reduced or unreduced form, the
inlet being fluidically coupled with the compressed air supply line
79. The compressed air supply connection 21 of the test apparatus 1
can be coupled with a compressed air supply line connection 84 of a
compressed air line, which is fluidically coupled with the
T-connection 83 or the compressed air outlet of the cleaning
apparatus 3. Alternatively, the compressed air supply connection 21
can be coupled with a compressed air supply line connection 84 that
is formed as the compressed air outlet of the cleaning apparatus 3.
The test apparatus 1 can be supplied with compressed air via the
compressed air supply line connection 84. Further preferably, the
compressed air source 77 produces a pressure of approx. 500 to
approx. 900 kPa (5 to 9 bar), which is applied to the compressed
air supply connection 21 of the test apparatus 1. The pressure
reducer 81 or the compressed air line 79 is/are preferably designed
such that at the compressed air inlet 85 of the cleaning apparatus
3 or the compressed air intake 67 of the pressure container merely
a pressure of approx. 100 to approx. 200 kPa (1 to 2 bar), further
preferably a pressure of approx. 200 kPa (2 bar), is applied.
[0094] Further preferably, the cleaning apparatus 3 comprises a
pressure sensor 130, which is preferably fluidically coupled with
the T-connection 83 to detect or measure the pressure of the
compressed air provided by the compressed air source 77. The
pressure sensor 130 can at least partially be arranged within the
housing 4 or be formed as an external pressure sensor 130.
Advantageously, it can de determined by means of the pressure
sensor 130 whether the compressed air source 77 provides the
preferred pressure of approx. 500 kPa to approx. 900 kPa. Thereby,
the pressure of the compressed air required for a safe operation of
the test apparatus 1 and the cleaning apparatus 3 can
advantageously be detected and monitored. Further preferably, on
the assumption that no pressure drops occur in the pressure
container 61 and in the fluid supply line 73, the pressure sensor
130 can also be used to determine the pressure of the fluid
supplied to the test apparatus 1.
[0095] The cleaning apparatus 3 further comprises at least one
connection 87a, 87b, 87c for a collecting container 89, which
during normal operation collects the fluids exiting or flowing out
of the internal volumes 35, 49, 51, 43, 47, 45, 37, 39, 41, 55, 33,
V.sub.11, V.sub.12, V.sub.13, V.sub.14, V.sub.15. At least one of
the connections 87a, 87b, 87c can preferably be arranged or formed
in or on the housing 4 of the cleaning apparatus 3. The collecting
container 89 comprises at least one fluid supply 91a, 91b, 91c and
a vent 93. For the normal operation of the cleaning apparatus 3,
the at least one fluid supply 91a, 91b, 91c of the collecting
container 89 can be fluidically coupled with one of the external
connections 23, 25, 27, 29 of the test apparatus 1 via at least one
fluid discharge line 95a and one fluid discharge connection 97a,
wherein the fluid discharge connection 97a is preferably a
connection that is complementary to the respective external
connection 23, 25, 27, 29, for example a plug-in nipple or a
plug-in coupling. It is understood that also a plurality of
external connections 23, 25, 27, 29 of the test apparatus 1 can be
coupled with an associated fluid supply 91a, 91b, 91c of the
collecting container 89 via an associated fluid discharge line 95a,
95b, 95c via fluid discharge connections 97a, 97b, 97c.
[0096] To advantageously prevent excess pressure from building up
in the collecting container 89, a vent 93 is provided to allow the
gaseous phase of the fluid supplied to the collecting container 89
and the air or gas displaced by the fluid in the connecting
container to escape into the environment. To prevent the test
apparatus 1 from being contaminated by a fluid flowing back from
the collecting container 89, the fluid supplies 91a, 91b, 91c are
preferably provided with a check valve. Particularly preferably,
the fluid supplies 91a, 91b, 91c are formed as plug-in nipples or
plug-in couplings, which each have a closure valve and/or a check
valve. Alternatively or in addition, a closure valve and/or a check
valve can be arranged in a complementary plug-in coupling or a
complementary plug-in nipple of the connections 87a, 87b, 87c of
the fluid discharge lines 95a, 95b, 95c. Further preferably, a
bacteria-retaining apparatus or a virus-retaining apparatus 101 is
arranged downstream of the vent 93 to advantageously prevent the
environment from being contaminated by pathogenic germs exiting the
test apparatus. The bacteria-retaining apparatus or the
virus-retaining apparatus 101 can be fluidically coupled with the
vent 93 by means of a retaining apparatus connection 88,
particularly be fluidically coupled in a sterile manner.
Preferably, the bacteria-retaining apparatus or the virus-retaining
apparatus 101 is at least partially arranged within the housing 4
of the cleaning apparatus 3, as is shown in FIG. 2, wherein the
retaining apparatus connection 88 is preferably arranged or formed
in or on the housing 4. Alternatively, the bacteria or
virus-retaining apparatus 101 can also be arranged as an external
apparatus outside the housing.
[0097] FIG. 3 shows a flow diagram of a preferred cleaning process
with reference to FIGS. 1 and 2. At the beginning of cleaning, the
test apparatus 1 is in a normal state, wherein the switching valves
11, 14 and the proportional valve 16 are closed and the switching
valves 12, 13, 15 are open. In an initialization step S10, a
pressure container 61 is filled with a cleaning fluid 63 and the
test apparatus 1 is put into a start state for cleaning, wherein
the switching valves 11, 12, 13, 14 and the proportional valve 16
are closed, while the switching valve 15 remains open.
[0098] In a subsequent step S14 of the cleaning process, the
cleaning apparatus 3 is provided and the compressed air valve 82 of
the cleaning apparatus 3 is closed. Subsequently, the compressed
air source 77 is coupled with the compressed air supply connection
21 of the test apparatus 1, the complementary connection 75 of the
fluid supply line 73 is connected with the external connection 23
of the test apparatus 1, and the fluid discharge lines 95a, 95b,
95c is connected with the external connections 25, 27, 29 via the
fluid connections 97a, 97b, 97c of the cleaning apparatus 3 during
a process step S16. In a further process step S18, the user is
asked to confirm the correct connection of the cleaning apparatus 3
with the test apparatus 1 and to start the cleaning of the test
apparatus 1, for example by operating a start button.
[0099] After cleaning has been started, the compressed air valve 82
is opened in a step S20, so that compressed air enters the pressure
container 61 from the compressed air source 77 via the T-connection
83, the pressure reducer 81, the compressed air valve 82, and the
compressed air line 79. Thereby, excess pressure builds up within
the pressure container 61, which preferably is approx. 1 to 2 bar,
further preferably approx. 2 bar. In a further step S22, preferably
after a predetermined or predeterminable operating pressure within
the pressure container 61 has been reached, the user is asked to
confirm the proper state of the test apparatus 1 and the cleaning
apparatus 3. Particularly, the user can check during this step
whether a leakage occurred in the cleaning apparatus 3 with excess
pressure.
[0100] After the confirmation, the actual cleaning process or the
actual cleaning steps are performed. In a step S24, the switching
valves 12, 13 are opened and the switching valve 15 is closed to
fill the internal reference tank 33 with the cleaning fluid 63 from
the pressure container 61. In doing so, due to the excess pressure
in the pressure container 61, i.e. by pneumatic conveyance, the
cleaning fluid 63 rises through the riser pipe 71 via the fluid
supply line 73 to the external connection 23 for internal
ventilation of the test apparatus 1. Starting from the external
connection 23, the cleaning fluid 63 flows to the internal
reference tank 33 via the line 43, the switching valve 13, the
lines 39, 35, 37, the switching valve 12, and the line 49. From
there, the cleaning fluid 63 can flow further via the line 51 and
from the external connection out of the test apparatus. Filling of
the internal reference tank 33 is preferably determined by means of
a predetermined or predeterminable filling time T24.
[0101] Subsequently, after the internal reference tank 33 has been
filled, filling of the external connection 27, which is adapted for
connection of a filter 5 or a container 7, is performed in a step
S26. To this end, in step S26, the switching valve 12 is closed and
the switching valve 14 is opened, so that the cleaning fluid 63 can
flow to the external connection 27 via the line 35, the switching
valve 14, and the line 47. Preferably, the filling process is
time-controlled and thus terminated after a predeterminable filling
time T26. Finally, in a step S28, the remaining part of the
internal volumes, i.e. the line 41, the switching valve 15, and the
line 45, are filled with the cleaning fluid 63 after the switching
valve 15 has been opened. This filling process is also terminated
preferably after a predeterminable filling time T28.
[0102] Filling of the internal volumes during the cleaning steps
S24, S26, and S28 usually causes cleaning fluid 63 to exit the test
apparatus 1 via the external connections 25, 27, 29. This exiting
cleaning fluid 63 is lead to a collecting container 89 via the
fluid discharge lines 95a, 95b, 95c connected to the external
connections 25, 27, 29. Preferably, the filling times T24, T26, and
T28 are such that cleaning fluid exits from all external
connections 25, 27, 29 and flows to the collecting container 89, so
that it is advantageously ensured that all internal volumes are
filled with cleaning fluid 63.
[0103] In a subsequent cleaning step S30, the switching valves 13,
14 are closed and the switching valve 12 is opened. In this state
of the test apparatus 1, the cleaning fluid 63 resides within the
internal volumes, so that contaminations can be removed from the
walls of the internal volumes by soaking or dissolving by means of
the cleaning fluid 63. In this state, the test apparatus pauses for
a predetermined or predeterminable soaking time T30, which is
preferably approx. 10 to approx. 60 minutes.
[0104] At the end of the cleaning process, the switching valve 12
is closed in a cleaning step S32. To substantially drain the
internal volumes filled with the cleaning fluid 63, the following
measures are conducted in a step S34. The compressed air valve 82
of the cleaning apparatus 3 is closed and the connection 85 of the
compressed air line 79 is disconnected from the compressed air
outlet 86, which is fluidically coupled with the compressed air
valve 82. Preferably, this step has to be performed and confirmed
by the user. Subsequently, the fluid discharge line 95c at the
connection for the collecting container 87c is disconnected from
the fluid supply 91c of the collecting container 89, and the fluid
discharge line 95c is fluidically coupled with the compressed air
outlet 86 by means of the connection 87c. Alternatively, the
compressed air supply line 79 at the compressed air connection 59
could be disconnected from the compressed air intake 67 of the
pressure container 61 to couple the compressed air connection 59
with the external connection 29 of the test apparatus.
[0105] The fluid supply line 73 between the pressure container 61
and the external connection 23 of the test apparatus 1 is
disconnected from the fluid exit 69 of the pressure container 61.
Instead, the fluid supply line 73 is coupled with the fluid
connection 91c of the collecting container 89 by means of the
connection 57.
[0106] FIG. 4 shows the arrangement of the test apparatus 1 and the
cleaning apparatus 3 after step S34 has been performed. The
following further description of the cleaning process thus relates
to FIG. 4. The proper establishment of all fluid connections is
preferably indicated to the system by a user input in a step
S40.
[0107] To drain the internal volumes, the compressed air valve 82
is opened in a step S42, so that excess pressure builds up at the
external connection 29. The proper state of the test apparatus 1
and of the cleaning apparatus 3, in particular the tightness of all
connections, is confirmed by the user by a user input in a step
S44.
[0108] After that, the switching valve 12 is opened in a step S46.
By opening the switching valve 12, the excess pressure applied to
the external connection 29, which is provided by the compressed air
source 77, is applied to the internal volumes 51, 33, 49, V12, 37,
35, 39, 55, so that successive draining of the internal volumes can
be started with subsequently. In a step S48, the switching valve 13
is opened to drain the internal reference tank 33 via the external
connection 23. The drain time T48 is preferably at least approx.
120 seconds.
[0109] To drain the internal volumes V11, 35, 39, V13, 43, the
switching valve 12 is closed in a step S50, the switching valve 14
is opened, and the proportional valve 16 is at least partially,
preferably approx. 50%, opened. The duration T50 of the pressure
buildup is preferably approx. 10 seconds. After that, in the step
S50, the switching valve 11 is opened, and the switching valves 13,
14 are alternatingly opened and closed, preferably for a duration
of approx. 10 seconds. Further preferably, the overlap time, during
which both switching valves 13, 14 are open or closed, is approx. 1
s or more. In this step S50, the cleaning fluid 63 can be drained
from the volumes of the lines 35, 39, 43, 41, 45, 47 and the
volumes V13, V14, V15 of the switching valves 13, 14, 15 via the
external connections 23, 25, 27 into the collecting container
89.
[0110] In a subsequent step S52, the switching valves 11, 14, 15
are opened and the switching valves 12, 13 are closed, wherein the
proportional valve 16 remains opened preferably approx. 50%. Now,
the switching valve 15 is opened and closed in an alternating
manner, preferably at intervals of approx. 10 seconds, to drain the
internal volumes of the switching valve 15 and the lines 41, 45 via
the external connection 25. The lines 47 are drained alternatingly
via the connection 27.
[0111] Subsequently, in step S54, all switching valves 11, 13, 14,
15 except for the switching valve 12, which separates the internal
reference tank 33, and the proportional valve 16 are opened to
drain all external connections 23, 25, 27 except for the external
connection 29 for the external reference tank 31, which has already
been drained via the internal reference tank 33. After a
predetermined or predeterminable drain time, all switching valves
11, 12, 13, 14 and the proportional valve 16 are closed, while the
switching valve 15, which is associated with the external vent 25,
remains open. After the step S56 has been completed, flushing of
the internal volumes is prepared.
[0112] After the test apparatus 1 has been drained, the flushing of
the internal volumes of the test apparatus 1 is prepared in a step
S58. To this end, the compressed air valve 82 is closed and the
test apparatus 1, the cleaning apparatus 3, and the pressure
container 61--as is shown in FIG. 2--are fluidically coupled with
each other (step S59). This structure corresponds to the structure
shown in FIG. 2, which was used to clean the test apparatus 1 by
means of the cleaning fluid 63, wherein instead of the cleaning
fluid 63, the pressure container 61 was filled with a flushing
fluid 65 different from the cleaning fluid 63, or wherein the
pressure container 61 containing the cleaning fluid 63 was
exchanged for a pressure container 61 containing the flushing fluid
65.
[0113] As soon as the corresponding connections are correctly
connected with each other, the proper assembly of the test
apparatus 1 with the cleaning apparatus 3 is confirmed by the user
(step S60). Subsequently, in a step S62, the compressed air valve
82 is opened. The compressed air valve 82 can be opened
automatically or manually, wherein the opening of the compressed
air valve 82 is then confirmed by the user in a step S64.
[0114] To fill the internal reference tank 33, the switching valves
12, 13 are opened in a step S66. The switching valve 15 is also
open, while the switching valves 11, 14 and the proportional valve
16 are closed. After a predetermined flushing time T66, the
switching valve 12 is closed and the switching valve 14 is opened
to fill the internal volume of the test connection 27 and the
coupling line 47 with flushing fluid 65 in a step S68. After a
predetermined flushing time T68, the switching valve 15 is opened
to fill the internal volumes of the coupling lines 41, 45 and the
switching valve 15 with the flushing fluid 65 in a step S70.
Preferably, the cleaning steps S66, S68, and S70 can be repeated in
an alternating manner. After that, the switching valves 12, 13, 14,
15 are opened to flush all external connections 23, 25, 27, 29 of
the test apparatus 1 with the flushing fluid 65 in a step S72. The
flushing fluid 65 exiting the test apparatus 1 during the flushing
of the internal volumes is lead into the collecting container 89
via the fluid discharge lines 95a, 95b, 95c. At the end of the
flushing process, the switching valves 11, 12, 13, 14, and 16 are
closed in a step S74. Further, the compressed air valve 82 is
closed in a step S76, wherein the closing of the compressed air
valve 82 is confirmed by the user in a step S78.
[0115] To drain the flushing fluid 65 off the internal volumes of
the test apparatus 1 or to dry the internal volumes of the test
apparatus 1, the connection 85 of the compressed air line 79 is
disconnected from the compressed air outlet 86. Preferably, this
step has to be performed and confirmed by the user. Subsequently,
the fluid discharge line 95c at the connection for the collecting
container 87c is disconnected from the fluid supply 91c, and the
fluid discharge line 95c is fluidically coupled with the compressed
air outlet 86 by means of the connection 87c. The fluid supply line
73 is removed from the pressure container 61. Instead, the fluid
supply line 73 is coupled with the fluid connection 91c of the
collecting container 89 by means of the connection 57.
[0116] To drain the flushing fluid 65 off the internal volumes of
the test apparatus 1 or to dry the internal volumes of the test
apparatus 1, the compressed air supply line 79 can be disconnected
from the pressure container 61 as an alternative to the
above-described procedure, to couple the compressed air supply line
79 with the test apparatus 1, preferably by connecting the
compressed air connection 59 with the connection 29 for an external
reference tank, wherefore the fluid discharge line 95c has been
removed from this connection in advance. The fluid supply line 73
can also be removed, which is coupled with the connection 23 of the
test apparatus 1. The fluid discharge line 95c is then coupled with
the connection 23.
[0117] This results in a structure as is shown in FIG. 4. The
proper assembly is confirmed by the user in a step S79.
[0118] Subsequently, the compressed air valve 82 is opened in a
step S80, and the opening of the compressed air valve 82 is
confirmed by the user in a step S82.
[0119] In a first step S84 of drying the internal volumes of the
test apparatus 1, the switching valves 12, 13 are opened. After a
predetermined or predeterminable drying time T84 or preferably
approx. 120 seconds, the switching valve 12 is closed to suppress
the flow of compressed air through the internal reference tank 33
in a drying step S86. Preferably, the switching valve 12 remains
closed for a period of approx. 10 seconds during the drying step
S86. Further preferably, the steps S84 and S86 are performed in an
alternating manner. Further preferably, the steps S84 and S86 are
repeated approx. fifteen times.
[0120] Subsequently, in a step S88, the switching valves 11, 12, 14
are closed and the switching valves 13, 15 are opened. Furthermore,
the proportional valve 16 is opened at least partially, preferably
approx. 50%. Since the switching valve 11 is closed, a pressure is
build up via the compressed air supply connection 21 and the
proportional valve 16. After that, the switching valve 11 is opened
and then, preferably several times, the switching valves 13, 14 are
opened and closed in an alternating manner. Preferably, the opening
and closing times of the switching valves 13, 14 are approx. 10
seconds. Further preferably, the overlap time during which both
switching valves 12, 14 are open or closed at the same time, is
approx. 1 s. After a predetermined or predeterminable drying time
T80 of preferably approx. 2 minutes, the cleaning step S88 is
terminated.
[0121] Subsequently, the switching valves 11, 14, 15 are opened and
the switching valves 12, 13 are closed. To dry the connection 25
for the external ventilation of the test apparatus 1, the switching
valve 15 is alternatingly opened and closed in a step S90, wherein
the opening and closing times preferably are approx. 10 seconds.
After a predetermined drying time T90, the switching valves 11, 13,
14, 15 are opened and the switching valve 12 is closed to dry all
external connections 23, 25, 45, 29 in a step S92. At the end of
the drying process, the switching valves 11, 12, 13, 14 and the
proportional valve 16 are closed in a step S94. The compressed air
valve 82 is also closed. The termination of the cleaning process
can preferably be confirmed by a user. Further preferably, the test
apparatus can be put into a normal state after cleaning, in which
the switching valves 11, 14 and the proportional valve 16 are
closed, while the switching valves 12, 13, 15 are open.
[0122] It is understood that the actuation of the compressed air
valve 82 and the establishment and disconnection of the
corresponding required fluid connections between the test apparatus
1, the cleaning apparatus 3, and the pressure container 61 can be
performed both manually by a user and automatically by
corresponding switching means. Accordingly, the cleaning process
can be performed as a computer-assisted cleaning process or as a
manual cleaning process.
[0123] Preferably, the cleaning process comprises the step of
logging the course of the cleaning process, for example by storage
on a data carrier, by generating a printout of a cleaning protocol,
or by transmitting the cleaning protocol over a data line. Further
preferably, the cleaning process comprises the step of determining
the predetermined or predeterminable times T24, T26, T28, T30, T48,
T50, T66, T68, T80, T84, and T90, particularly by performing a test
run.
[0124] FIG. 5 shows the schematic structure of a further preferred
embodiment of a cleaning apparatus 3 for a test apparatus 1 for
testing filters and/or sterile disposable containers. The cleaning
apparatus 3 is adapted to be operated with a first pressure
container 61a, which contains a cleaning fluid 63 during normal
operation, and with a second pressure container 61b, which contains
a flushing fluid 65 during normal operation. To this end, the
cleaning apparatus 3 comprises a first fluid connection 57a and a
first compressed air connection 59a for the first pressure
container 61a, and a second fluid connection 57b and a second
compressed air connection 59b for the second pressure container
61b. The compressed air connections 59a, 59b and/or the fluid
connections 57a, 57b are preferably formed or arranged in or on a
housing 4 of the cleaning apparatus.
[0125] The first and second pressure containers 61a, 61b comprise a
compressed air intake 67a, 67b, respectively, which can be coupled
with the associated compressed air connection 59a, 59b, and first
and second fluid exits 69a, 69b, which can be coupled with the
associated first or second fluid connection 57a, 57b. Here, riser
pipes 71a, 71b are fluidically coupled with the associated fluid
exits 69a, 69b, respectively. The riser pipes 71a, 71b preferably
extend down to the bottoms of the pressure containers 61a, 61b. If
the pressure containers 61a, 61b are fed with compressed air via
the compressed air intakes 67a, 67b, excess pressure builds up
within the pressure containers 61a, 61b, due to which the cleaning
fluid 63 contained in the pressure container 61a or the flushing
fluid 65 contained in the pressure container 61b can rise within
the riser tubes to escape from the pressure containers 61a, 61b
through the fluid exits 69a, 69b.
[0126] To supply compressed air to the first and second pressure
containers 61a, 61b, the compressed air intakes 67a, 67b of the
pressure containers 61a, 61b can be coupled with a compressed air
source 77. Preferably, the compressed air intakes 67a, 67b are
fluidically coupled with the compressed air source 77 via a common
compressed air supply line 79 and compressed air valve 82. The
compressed air supply line 79 can comprise a compressed air inlet
85 as well as a first compressed air connection 59a for the first
pressure container 61a and a second compressed air connection 59b
for the second pressure container 61b. The compressed air valve 82
can be formed as a proportional valve, which is preferably
controlled electrically, and can act as a pressure reducer. In
particular, the compressed air source 77 can be the same compressed
air source 77 that provides the compressed air at the compressed
air supply connection 21 of the test apparatus 1. Here, a
T-connection 83 can be arranged between the compressed air source
77 and the compressed air supply connection 21, so that the
compressed air supply connection 21 and the compressed air intake
67 together are fluidically coupled with the pressure source 77. It
is understood that both the compressed air valve 82 and the
T-connection 83 can be part of the cleaning apparatus 3, i.e. for
example can be arranged at least partially in the housing 4 with
other components of the cleaning apparatus 3. In this case, the
cleaning apparatus 3 has a compressed air inlet and a compressed
air supply line connection 84, which can be fluidically coupled
with the compressed air supply connection 21 of the test apparatus
1. Preferably, the cleaning apparatus 3 can have a compressed air
outlet 86 to which an external compressed air supply connection 79
can be coupled. Alternatively, the compressed air valve 82 and/or
the T-connection 83 can be designed as external components, wherein
the compressed air is supplied to the compressed air inlet 85 of
the cleaning apparatus 3, which is fluidically coupled with the
compressed air supply line 79, in a reduced or unreduced form.
Further preferably, the compressed air source produces a pressure
of approx. 500 to approx. 900 kPa (5 to 9 bar), which is applied to
the compressed air supply connection 21 of the test apparatus 1.
The compressed air valve 82 is preferably designed or adjusted such
that at the compressed air inlet 85 of the cleaning apparatus 3 or
at the compressed air intakes 67a, 67b of the pressure containers
61a, 61b merely a pressure of approx. 100 to approx. 200 kPa (1 to
2 bar), further preferably of approx. 2 bar, is applied.
[0127] Further preferably, the cleaning apparatus 3 comprises a
pressure sensor 130 and/or a moisture sensor 132, which is/are
preferably fluidically coupled with the T-connection 83 to detect
or measure the pressure or moisture of the compressed air provided
by the compressed air source 77. Both the pressure sensor 130 and
the moisture sensor 132 can at least partially be arranged within
the housing 4 or be formed or arranged externally. Advantageously,
it can de determined by means of the pressure sensor 130 whether
the compressed air source 77 provides the preferred pressure of
approx. 500 kPa to approx. 900 kPa. Thereby, the pressure of the
compressed air required for a safe operation of the test apparatus
1 and the cleaning apparatus 3 can advantageously be detected and
monitored. Further preferably, the relative and/or absolute
moisture of the provided compressed air can be detected or measured
by means of the moisture sensor. Thereby, it can be checked, for
example, whether the provided compressed air has a sufficiently low
moisture content for drying the internal volumes. Further
preferably, at least one further moisture sensor can be provided,
which is fluidically coupled with one of the external connections
23, 25, 27 to detect or measure the moisture of the air exiting the
internal volumes. Advantageously, the progress or the quality of
the drying process can be monitored or determined. In particular,
the drying process can be terminated when the moisture of the
exiting air reaches or falls below a predetermined threshold value
relative to the moisture of the provided compressed air.
[0128] For the normal operation of the cleaning apparatus 3, the
first fluid exit 69a of the first pressure container 61a can be
coupled fluidically with one of the external connections 23, 25,
27, 29 of the test apparatus 1, preferably with the connection 23
for internal ventilation, via the first fluid connection 57a and a
fluid supply line 73a, a first fluid supply switching valve 99a,
and a fluid supply line 73, wherein the connection can preferably
be established by means of a complementary or mating connection 75,
for example by means of a plug-in nipple or a plug-in coupling.
Preferably, the cleaning apparatus 3 has a temperature and/or a
pressure sensor (not shown), which is thermally and/or fluidically
coupled with the fluid supply line 73 to detect the temperature
and/or the pressure of the supplied cleaning fluid 63 or flushing
fluid 65.
[0129] Accordingly, the second fluid exit 69b of the second
pressure container 61b can be coupled hydraulically with the above
external connection 23 via the second fluid connection 57b and a
fluid supply line 73b, a second fluid supply switching valve 99b,
and the fluid supply line 73. By means of the fluid supply
switching valves 99a, 99b, it can be controlled, preferably in a
computer-assisted or automatic manner, whether the cleaning fluid
63 of the first pressure container 61a or the flushing fluid 65 of
the second pressure container 61b is supplied to the test apparatus
1. A manual disconnection and coupling of the fluid lines is
advantageously not required for that.
[0130] The cleaning apparatus 3 further comprises at least one
connection 87a, 87b, 87c, 87d for a collecting container 89, which
during normal operation collects the fluids exiting or flowing out
of the internal volumes 35, 49, 51, 43, 47, 45, 37, 39, 41, 55, 33,
V.sub.11, V.sub.12, V.sub.13, V.sub.14, V.sub.15 of the test
apparatus 1. The collecting container 89 comprises at least one
fluid supply 91a, 91b, 91c, 91d and a vent 93. For the normal
operation of the cleaning apparatus 3, the at least one fluid
supply 91a, 91b, 91c, 91d of the collecting container 89 can be
fluidically coupled with one of the external connections 23, 25,
27, 29 of the test apparatus 1 via at least one fluid discharge
line 95a and one fluid discharge connection 97a, wherein the fluid
discharge connection 97a is preferably a connection that is
complementary to the respective external connection 23, 25, 27, 29,
for example a plug-in nipple or a plug-in coupling. It is
understood that also a plurality of external connections 23, 25,
27, 29 of the test apparatus 1 can be coupled with an associated
fluid supply 91a, 91b, 91c, 91d of the collecting container 89 via
an associated fluid discharge line 95a, 95b, 95c, 95d via fluid
discharge connections 97a, 97b, 97c.
[0131] To advantageously prevent excess pressure from building up
in the collecting container 89, at least one vent 93 is provided to
allow the gaseous phase of the fluid supplied to the collecting
container 89 and the air displaced by the fluid in the connecting
container to escape into the environment. To prevent the test
apparatus 1 from being contaminated by a fluid flowing back from
the collecting container 89, the fluid supplies 91a, 91b, 91c, 91d
are preferably provided with a check valve. Particularly
preferably, the fluid supplies 91a, 91b, 91c, 91d are formed as
plug-in nipples or plug-in couplings, which each have a closure
valve and/or a check valve. Alternatively, a closure valve and/or a
check valve can be arranged in a complementary plug-in coupling or
a complementary plug-in nipple of the connections 87a, 87b, 87c,
87d of the fluid discharge lines 95a, 95b, 95c, 95d. Further
preferably, a bacteria-retaining apparatus or a virus-retaining
apparatus 101 is arranged downstream of the vent 93 to
advantageously prevent the environment from being contaminated by
pathogenic germs exiting the test apparatus. The bacteria-retaining
apparatus or the virus-retaining apparatus 101 can be fluidically
coupled with the vent 93 particularly by means of a retaining
apparatus connection 88, particularly be fluidically coupled in a
sterile manner. Preferably, the bacteria-retaining apparatus or the
virus-retaining apparatus 101 is at least partially arranged within
the housing 4 of the cleaning apparatus 3, as is shown in FIG. 2,
wherein the retaining apparatus connection 88 is preferably
arranged or formed in or on the housing 4. Alternatively, the
bacteria or virus-retaining apparatus 101 can also be arranged as
an external apparatus outside the housing.
[0132] To enable both the filling of the internal volumes of the
test apparatus 1 with a cleaning fluid 63 or a flushing fluid 65
via the complementary connection 75 and the draining into the
collecting container 89 via one of the fluid discharge connections
97d, the cleaning apparatus 3 comprises a first outlet switching
valve 103, which is controlled in an opposite manner to the first
and second fluid supply switching valves 99a, 99b. In this case,
the complementary connection 75 and the fluid discharge connection
97d are identical and coupled with the external connection 23 for
internal ventilation of the test apparatus 1. The first discharge
switching valve 103 is closed when at least one of the two fluid
supply switching valves 99a, 99b is opened. Contrary, the first
discharge switching valve 103 is only opened when both fluid supply
switching valves 99a, 99b are closed. Thus, a contamination of the
cleaning fluid 63 in the pressure container 61a and of the flushing
fluid 65 in the pressure container 61b by fluid flowing back can
advantageously prevented.
[0133] To further enable both the supply of compressed air to the
external connection 29 for the external reference tank via the
fluid discharge connection 97a and the drainage into the collecting
container 89, the cleaning apparatus 3 comprises a second discharge
switching valve 105, which is controlled in an opposite manner to a
compressed air supply switching valve 107. In other words, the
second discharge switching valve 105 is closed when the compressed
air supply switching valve 107 is opened, and vice versa. Thus, a
contamination of the compressed air supply line 79 by fluid flowing
back can advantageously be prevented.
[0134] Alternatively or in addition to the compressed air supply
switching valve 107, a first bypass valve 115a can be arranged
between the first fluid connection 57a and the first compressed air
connection 59a for the first container 61a to enable the supply of
compressed air via the external connection 23 of the test apparatus
1. Further alternatively or in addition to the compressed air
supply switching valve 107 and/or the first bypass valve 115a, a
second bypass valve 115b can be arranged between the second fluid
connection 57b and the second compressed air connection 59b for the
second container 61b to enable the supply of compressed air via the
external connection 23 of the test apparatus.
[0135] Preferably, the cleaning apparatus 3 can have a hot steam
supply connection 122, which can be particularly formed or arranged
in or on the housing 4. The hot steam supply connection 122 is
adapted to be fluidically coupled with a hot steam connection 124
of a hot steam generator 125. Hot steam generated by the hot steam
generator 125 can be supplied to the cleaning apparatus 3 via the
hot steam supply connection 122 and a hot steam switching valve
120. It is understood that the hot steam generator 125 can
alternatively be formed within the housing 4 of the cleaning
apparatus 3.
[0136] Via the compressed air supply line 79 and the compressed air
supply switching valve 107, the hot steam can be supplied either
directly to the test apparatus 1 via the external connection 29 or
be supplied to the external connection 23 via at least one of the
pressure containers 61a, 61b, the fluid supply lines 73a, 73b.
Advantageously, a sterilization of the internal volumes can be
performed by means of the hot steam. Particularly preferably, a
sterilization of the pressure container(s) 61a, 61b can be
performed by supplying hot steam via one of the pressure containers
61a, 61b or via both pressure containers 61a, 61b at the same
time.
[0137] FIG. 6 shows a flow diagram of a preferred automatic,
particularly computer-assisted, cleaning process with reference to
FIGS. 1 and 5. It is understood that switching of the valves cannot
only be performed automatically, but also manually. Preferably, a
user is interactively requested to take several actions at the
beginning of and optionally during the cleaning process, for
example, couple tubes to specific external connections, and to
subsequently confirm these actions via an input unit (not shown).
Further preferably, switching of the valves is performed
automatically according to a cleaning program to be selected.
[0138] At the beginning of the cleaning process, the test apparatus
1 is preferably in a normal state, wherein the switching valves 11,
14 and the proportional valve 16 are closed and the switching
valves 12, 13, 15 are open. In an initialization step S110, a first
pressure container 61a is filled with a cleaning fluid 63 and a
second pressure container 61b is filled with a flushing fluid 65.
The compressed air intakes 67a, 67b and the fluid exits 69a, 69b of
the pressure containers 61a, 61b are coupled with the associated
compressed air connections 59a, 59b and fluid connections 57a, 57a,
respectively, of the cleaning apparatus 3. Further preferably, the
required complementary external connections 75, 84, 97a, 97b, 97c,
97d of the cleaning apparatus 3 are coupled with the associated
external connections 21, 23, 25, 27, 29 of the test apparatus 1.
This can preferably be done by means of a connection device 109,
which can be coupled with a complementary connection device 111 (as
is shown in FIGS. 7a and 7b) of the test apparatus 1. The cleaning
apparatus 3 is in an initial state, wherein the compressed air
valve 82, the first 99a and second 99b fluid supply switching
valves, the first 103 and second 105 discharge switching valves,
and the compressed air supply switching valve 107 are closed. The
correct coupling of the cleaning apparatus 3 with the test
apparatus 1 is confirmed by the user via the input unit, for
example by actuating a start button (not shown).
[0139] The steps of the cleaning process described in the following
are preferably performed automatically without any further user
input. The test apparatus 1 is put into a start state for cleaning,
wherein the switching valves 11, 12, 13, 14 and the proportional
valve 16 are closed, while the switching valve 15 remains open
(step S112).
[0140] After the cleaning process has been started, the compressed
air valve 82 is opened in a step S120, so that compressed air from
the compressed air source 77 gets into the pressure containers 61a,
61b via the T-connection 83, the compressed air valve 82, and the
compressed air line 79. Thereby, excess pressure builds up within
the pressure containers 61a, 61b, which preferably is approx. 1.1
to 2 bar, further preferably approx. 2 bar. In a step S124, the
first fluid supply switching valve 99a, the switching valves 12, 13
are opened and the switching valve 15 is closed to fill the
internal reference tank 33 with the cleaning fluid 63 from the
pressure container 61a. In doing so, due to the excess pressure in
the pressure container 61a, i.e. by pneumatic conveyance, the
cleaning fluid 63 rises through the riser pipe 71a via the fluid
supply lines 73a, 73 to the external connection 23 for internal
ventilation of the test apparatus 1. Starting from the external
connection 23, the cleaning fluid 63 flows to the internal
reference tank 33 via the line 43, the switching valve 13, the
lines 39, 35, 37, the switching valve 12, and the line 49. From
there, the cleaning fluid 63 can flow further via the line 51 and
from the external connection 29 out of the test apparatus. Filling
of the internal reference tank 33 is preferably determined by means
of a predetermined or predeterminable filling time T124.
[0141] Subsequently, after the internal reference tank 33 has been
filled, the external connection 27, which is adapted for connection
of a filter 5 or a container 7, is filled with cleaning fluid in a
step S126. To this end, in step S126, the switching valve 12 is
closed and the switching valve 14 is opened, so that the cleaning
fluid 63 can flow to the external connection 27 via the line 35,
the switching valve 14, and the line 47. Preferably, the filling
process is time-controlled and thus terminated after a
predetermined or predeterminable filling time T126. Finally, in a
step S128, the remaining part of the internal volumes, i.e. the
line 41, the switching valve 15, and the line 45, are filled with
the cleaning fluid 63 after the switching valve 15 has been opened.
This filling process is also terminated preferably after a
predetermined or predeterminable filling time T128.
[0142] Filling of the internal volumes during the cleaning steps
S124, S126, and S128 usually causes cleaning fluid 63 to exit the
test apparatus 1 via the external connections 25, 27, 29. This
exiting cleaning fluid 63 is lead to a collecting container 89 via
the fluid discharge lines 95a, 95b, 95c connected to the external
connections 25, 27, 29. Preferably, the filling times T24, T26, and
T28 are such that cleaning fluid exits from all external
connections 25, 27, 29 and flows to the collecting container 89, so
that it is advantageously ensured that all internal volumes are
filled with cleaning fluid 63 and all contaminations are already
flushed out.
[0143] In a subsequent cleaning step S130, the switching valves 13,
14 are closed and the switching valve 12 is opened. In this state
of the test apparatus 1, the cleaning fluid 63 resides temporarily
within the internal volumes, so that contaminations can be removed
from the walls of the internal volumes by soaking or dissolving by
means of the cleaning fluid 63. In this state, the test apparatus
pauses for a predetermined soaking time T130, which is preferably
approx. 10 to approx. 60 minutes.
[0144] At the end of the cleaning process, the switching valve 12
is closed in a cleaning step S132. To drain the internal volumes
filled with the cleaning fluid 63, the following measures are
conducted in a step S146. The first fluid supply switching valve
99a and the second discharge switching valve 105 are closed, while
the first discharge valve 103 and the compressed air supply
switching valve 107 are opened. Thereby, the external connection 29
of the test apparatus 1 is supplied with compressed air via the
compressed air line 79, the compressed air supply switching valve
107, and the fluid discharge line 95c. After the switching valve 12
has been opened, the excess pressure applied to the external
connection 29, which is provided by the compressed air source 77,
is applied to the internal volumes 51, 33, 49, V.sub.12, 37, 35,
39, 55, so that successive draining of the internal volumes can be
started with subsequently. In a step S148, the switching valve 13
is opened to drain the internal reference tank 33 via the external
connection 23. The drain time T148 is preferably at least approx.
120 seconds.
[0145] To drain the internal volumes V.sub.11, 35, 39, V.sub.13,
43, the switching valve 12 is closed in a step S150, the switching
valve 14 is opened, and the proportional valve 16 is at least
partially, preferably approx. 50%, opened. The duration T150 of the
pressure buildup is preferably approx. 10 seconds. After that, in
the step S150, the switching valve 11 is opened, and the switching
valves 13, 14 are alternatingly opened and closed, preferably for a
duration of approx. 10 seconds. Further preferably, the overlap
time, during which both switching valves 13, 14 are open or closed,
is approx. 1 s or more. In this step S150, the cleaning fluid can
be drained from the volumes of the lines 35, 39, 43, 41, 45, 47 and
the volumes V.sub.13, V.sub.14, V.sub.15 of the switching valves
13, 14, 15 via the external connections 23, 25, 27 into the
collecting container 89.
[0146] In a subsequent step S152, the switching valves 11, 14, 15
are opened and the switching valves 12, 13 are closed, wherein the
proportional valve 16 remains opened preferably approx. 50%. Now,
the switching valve 15 is opened and closed in an alternating
manner, preferably at intervals of approx. 10 seconds, to drain the
internal volumes of the switching valve 15 and the lines 41, 45, 47
via the external connections 25, 27.
[0147] Subsequently, all switching valves 11, 13, 14, 15 except for
the switching valve 12, which separates the internal reference tank
33, and the proportional valve 16 are opened to drain all external
connections 23, 25, 27 except for the external connection 29 for
the external reference tank 31, which has already been drained via
the internal reference tank 33. After a predetermined or
predeterminable drain time, all switching valves 11, 12, 14 and the
proportional valve 16 are closed, while the switching valve 15,
which is associated with the external vent 25, and the switching
valve 13, which is associated with the internal vent 23, remain
open. After the step S156 has been completed, flushing of the
internal volumes is prepared.
[0148] After the test apparatus 1 has been drained, the flushing of
the internal volumes of the test apparatus 1 is prepared in a step
S162. The compressed air valve 82, the first discharge valve 103,
and the compressed air supply switching valve 107 are closed and
the second fluid supply switching valve 99b and the second
discharge switching valve 105 are opened. Thereby, flushing fluid
65 from the second pressure container 61b can be pneumatically
conveyed to the external connection 23 of the test apparatus 1.
Subsequently, the compressed air valve 82 is opened.
[0149] To fill the internal reference tank 33, the switching valves
12, 13 are opened in a step S166. The switching valve 15 is also
open, while the switching valves 11, 14 and the proportional valve
16 are closed. After a predetermined flushing time T166, the
switching valve 12 is closed and the switching valve 14 is opened
to fill the internal volume of the test connection 27 and the
coupling line 47 with flushing fluid 65 in a step S168. After a
predetermined flushing time T168, the switching valve 15 is opened
to fill the internal volumes of the coupling lines 41, 45 and the
switching valve 15 with the flushing fluid 65 in a step S170.
Preferably, the cleaning steps S66, S68, and S170 can be repeated
in an alternating manner. After that, the switching valves 12, 13,
14, 15 are opened to flush all external connections 23, 25, 27, 29
of the test apparatus 1 with the flushing fluid 65 in a step S172.
The flushing fluid 65 exiting the test apparatus 1 during the
flushing of the internal volumes is lead into the collecting
container 89 via the fluid discharge lines 95a, 95b, 95c. At the
end of the flushing process, the switching valves 11, 12, 13, 14,
and 16 and the compressed air valve 82 are closed.
[0150] Preferably, after the step S172, a drainage and
sterilization of the internal volumes can be performed. By analogy
with steps S146 to S156, draining is performed in the steps S146'
to S156'. As for the description of the steps S146' to S156'
described in FIG. 6, reference is made to the previous description
of the steps S146 to S156. Subsequently, sterilization can be
performed by means of hot steam. For sterilization, in a step S183,
the compressed air valve 82 is closed and the hot steam switching
valve 120 coming from the internal or external hot steam generator
125 is opened. Preferably, at least one of the completely drained
pressure containers 61a, 61b can be flown through by hot steam. To
this end, preferably all internal valves 11 to 16 are closed and
merely the fluid supply switching valves 99a, 99b and the first
discharge switching valve 103 are open. Preferably, also the second
discharge switching valve 105 and the compressed air supply
switching valve 107 are opened in a period of approx. 60 seconds,
preferably approx. 120 seconds, for approx. 10 seconds each in
order to sufficiently sterilize the fluid discharge line 95c and
the portion of the compressed air supply line 79 arranged between
the compressed air supply switching valve 107 and the fluid
discharge line 95c. The overall duration of the above-described
step 183 of sterilizing is preferably 30 to 60 minutes. This
process is optional; the pressure containers 61a, 61b might as well
be autoclaved separately.
[0151] In the further course, the internal volumes of the test
apparatus 1 can be sterilized. The steps S184' to S194' shown in
FIG. 6 correspond to the steps of drying S184 to S194. As for the
description of the steps S184' to S194' described in FIG. 6,
reference is made to the previous description of the steps S184 to
S194, wherein the following preferred deviation takes place: The
step 184' lasts until the required sterilization temperature of
approx. 121.degree. C., preferably approx. 134.degree. C., has been
reached in the internal reference tank 33 of the test apparatus.
This step then lasts for a further period of 30 to 60 minutes. It
is followed by the steps 188' to 192' for a total time of
preferably 30 to 60 minutes. Particularly, the temperature of the
exiting fluid and/or the temperature in the internal reference tank
can be monitored by means of the preferred temperature sensor in
order to increase the sterilization duration and the duration of
times in which the required temperature of approx. 121.degree. C.
or 134.degree. C. is fallen below.
[0152] To drain the flushing fluid 65 from the internal volumes of
the test apparatus 1 or to dry the internal volumes of the test
apparatus 1, the following measures are conducted in a step S184.
The second fluid supply switching valve 99b and the second
discharge switching valve 105 are closed, while the first discharge
valve 103 and the compressed air supply switching valve 107 are
opened. Thereby, the external connection 29 of the test apparatus 1
is supplied with compressed air via the compressed air line 79, the
compressed air supply switching valve 107, and the fluid discharge
line 95c. In a step S186 of drying the internal volumes of the test
apparatus 1, the switching valves 12, 13 are opened. After a
predetermined or predeterminable drying time T86 or preferably
approx. 120 seconds, the switching valve 12 is closed to suppress
the flow of compressed air through the internal reference tank 33.
Preferably, the switching valve 12 remains closed for a time or
approx. 10 seconds. Further preferably, opening and closing of the
switching valve 12 is performed in an alternating manner and
further preferably repeated approx. five to fifteen times.
[0153] Subsequently, in a step S188, the switching valves 11, 12,
14 are closed and the switching valves 13, 15 are opened.
Furthermore, the proportional valve 16 is opened at least
partially, preferably approx. 50%. Since the switching valve 11 is
closed, a pressure is build up via the compressed air supply
connection 21 and the proportional valve 16. After that, the
switching valve 11 is opened and then, preferably several times,
the switching valves 13, 14 are opened and closed in an alternating
manner. Preferably, the opening and closing times of the switching
valves 13, 14 are approx. 10 seconds. Further preferably, the
overlap time during which both switching valves 12, 14 are open or
closed at the same time, is approx. 1 s. After a predetermined or
predeterminable drying time T188 of preferably approx. 2 minutes,
the cleaning step S188 is terminated.
[0154] Subsequently, the switching valves 11, 14, 15 are opened and
the switching valves 12, 13 are closed. To dry the connection 25
for the external ventilation of the test apparatus 1, the switching
valve 15 is alternatingly opened and closed in a step S190, wherein
the opening and closing times preferably are approx. 10 seconds.
After a predetermined or predeterminable drying time T190, the
switching valves 11, 13, 14, 15 are opened and the switching valve
12 is closed to dry all external connections 23, 25, 29 in a step
S192. At the end of the drying process, the switching valves 11,
12, 13, 14 and the proportional valve 16 are closed in a step S194.
The compressed air valve 82 is also closed. The successful
termination of the cleaning process can preferably be confirmed by
a user. Further preferably, the test apparatus can be put into a
normal state after cleaning, in which the switching valves 11, 14
and the proportional valve 16 are closed, while the switching
valves 12, 13, 15 are open.
[0155] Preferably, the cleaning process comprises the step of
logging the course of the cleaning process, for example by storage
on a data carrier, by generating a printout of a cleaning protocol,
or by transmitting the cleaning protocol over a data line. Further
preferably, the cleaning process comprises the step of determining
the predetermined or predeterminable times T124, T126, T128, T130,
T148, T150, T166, T168, T188, and T190, particularly by performing
a test run.
[0156] The FIGS. 7a and 7b show a preferred embodiment of a test
apparatus 1 with a complementary connection device 111 for
connection of the connection device of the cleaning apparatus. In
the illustrated embodiment, the external connections 21, 23, 25,
27, 29 of the test apparatus 1 are arranged on the complementary
connection device 111 in a fixed, geometrical arrangement to each
other, so that an associated or mating connection device of a
cleaning apparatus can be coupled with the complementary connection
device 111 in a simple manner.
[0157] Preferably, the connection device of the cleaning apparatus
can be arranged on the test apparatus 1 by a displacement movement
along the connection direction A, particularly by a linear
displacement, such that the complementary external connections of
the connection device can be fluidically coupled with the
associated external connections 21, 23, 25, 27, 29 of the test
apparatus 1. Advantageously, the required connections can be
established quickly and erroneous connections can be avoided.
[0158] It is understood that the control of the switching means,
i.e. of the valves, can be performed automatically or in a
computer-assisted manner during the cleaning process described with
reference to FIGS. 3 and 6. Particularly, the control of the
switching means can be performed by a single, non-illustrated
control unit, which may be located in the test apparatus 1 or in
the cleaning apparatus 3, or via two control units in communication
with each other, wherein one of the two control units is located in
the test apparatus 1 and the other is located in the cleaning
apparatus 3. Therefore, preferably at least one electrical
connection is provided between the test apparatus 1 and the
cleaning apparatus 3, particularly to transmit the control
signals.
[0159] The electrical connection between the test apparatus 1 and
the cleaning apparatus can preferably be established by
electrically contacting or connecting at least one connector of the
cleaning apparatus with an associated complementary connector 113
of the test apparatus 1. Preferably, the electrical connection can
be established by displacing the cleaning apparatus along the
connection direction A, particularly by a linear displacement.
Particularly, the electrical connection can have an interface, for
example a RS232 interface, a RS435 interface, a RJ45 interface
and/or a USB interface, with which preferably a data transfer
between the cleaning apparatus and the test apparatus 1 can take
place. Further preferably, the electrical connection can also take
care of the current supply of the cleaning apparatus.
Advantageously, a power supply in the cleaning apparatus can be
omitted then.
[0160] Further preferably, the complementary connection device 111
of the test apparatus 1 comprises the complementary connector 113.
Accordingly, the connection device of the cleaning apparatus can
comprise the connector, so that advantageously both the fluidic and
the electrical connection between the test apparatus 1 and the
associated cleaning apparatus can be established in a particularly
simple manner by means of the connection device and the
complementary connection device 111.
* * * * *