U.S. patent application number 14/044435 was filed with the patent office on 2014-02-13 for use of a device and a method for preparing mixtures of pharmaceutical substances.
This patent application is currently assigned to Sartorius Stedim Biotech GmbH. The applicant listed for this patent is Sartorius Stedim Biotech GmbH. Invention is credited to Maik Jornitz, Stefan Schlack.
Application Number | 20140041752 14/044435 |
Document ID | / |
Family ID | 45888163 |
Filed Date | 2014-02-13 |
United States Patent
Application |
20140041752 |
Kind Code |
A1 |
Jornitz; Maik ; et
al. |
February 13, 2014 |
USE OF A DEVICE AND A METHOD FOR PREPARING MIXTURES OF
PHARMACEUTICAL SUBSTANCES
Abstract
A method for the preparing mixtures of pharmaceutical or
biopharmaceutical substances (11, 11'') includes arranging a
preparation container (3, 3', 3'') already made up with ingredients
in a receptacle (2) of a device (1, 1', 1'') feeding a fluid (10)
from a storage container (4, 4'') into the preparation container
(3, 3'') via a feed line (6), preparing the ingredients with the
fluid (10, 10'') into a substance mixture (11, 11''), and removing
the substance mixture (11, 11'') from the preparation container (3,
3', 3'') into a receiving container via a discharge line (12, 12',
12''). A device also is provided for carrying out the method.
Inventors: |
Jornitz; Maik; (Manorville,
NY) ; Schlack; Stefan; (Goettingen, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sartorius Stedim Biotech GmbH |
Goettingen |
|
DE |
|
|
Assignee: |
; Sartorius Stedim Biotech
GmbH
Goettingen
DE
|
Family ID: |
45888163 |
Appl. No.: |
14/044435 |
Filed: |
October 2, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
PCT/EP2012/001170 |
Mar 16, 2012 |
|
|
|
14044435 |
|
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|
Current U.S.
Class: |
141/9 ;
141/85 |
Current CPC
Class: |
A61M 2205/7518 20130101;
A61M 39/08 20130101; A61J 2205/10 20130101; A61J 3/002 20130101;
A61M 2205/7509 20130101; B65B 3/003 20130101; A61J 1/2089
20130101 |
Class at
Publication: |
141/9 ;
141/85 |
International
Class: |
B65B 3/00 20060101
B65B003/00 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 12, 2011 |
DE |
10 2011 016 767.6 |
Claims
1. A method preparing mixtures of pharmaceutical or
biopharmaceutical substances (11, 11'') comprising the steps: a)
arranging a preparation container (3, 3', 3'') already made up with
ingredients in a receptacle (2) of a device (1, 1', 1''); b)
feeding a fluid (10) from a storage container (4, 4'') into the
preparation container (3, 3'') via a feed line (6); c) preparing
the ingredients with the fluid (10, 10'') into a substance mixture
(11, 11''); and d) removing the substance mixture (11, 11'') from
the preparation container (3, 3', 3'') into a receiving container
(13, 13', 13'') via a discharge line (12, 12', 12'').
2. The method of claim 1, wherein the pharmaceutical or
biopharmaceutical substances are medicaments that are individual to
a patient.
3. The method of claim 1, wherein after arranging the preparation
container (3, 3', 3'') in the receptacle (2) of the device (1, 1',
1''), the method further comprises using a reading unit (17) for
reading out a coding (16) of the preparation container (3), calling
up from a memory parameters necessary for carrying out the method
and making the coding (16) and the parameters available to a
monitoring and controlling unit (5).
4. A method for preparing mixtures of pharmaceutical or
biopharmaceutical substances (11') comprising the steps: a)
arranging a preparation container (3'') in a receptacle of a device
(1''), b) feeding ingredients from a plurality of ingredient
storage containers (23, 24, 25, 26) into the preparation container
(3''), c) feeding a fluid (10'') from a fluid storage container
(4'') into the preparation container (3'') via a feed line (6''),
d) preparing the ingredients with the fluid (10'') into a substance
mixture (11''), and e) removing the substance mixture (11'') from
the preparation container (3'') into a receiving container (3'')
via a discharge line (12'').
5. The method of claim 4 wherein the pharmaceutical or
biopharmaceutical substances are medicaments that are individual to
a patient.
6. The method of claim 4, wherein after arranging the preparation
container (3, 3', 3'') in the receptacle (2) of the device (1, 1',
1''), the method further comprises using a reading unit (17) for
reading out a coding (16) of the preparation container (3), calling
up from a memory parameters necessary for carrying out the method
and making the coding (16) and the parameters available to a
monitoring and controlling unit (5).
7. A device (1, 1', 1'') for the preparation of mixtures of
pharmaceutical or biopharmaceutical substances (11, 11''),
comprising: a preparation container (3, 3', 3'') with ingredients;
a receptacle (2) configured to receive the preparation container
(3, 3', 3''), a storage container (4, 4'') with a fluid (10, 10'')
that can be fed in a monitored manner to the preparation container
(3, 3', 3'') via a feed line (6); a receiving container that
communicates with the preparation container (3, 3', 3'') via a
discharge line (12, 12', 12''); and at least one sterile filter
(22), or at least one virus filter or at least one combination of a
sterile filter and a virus filter arranged upstream or downstream
of the preparation container (3, 3', 3'').
8. The device of claim 7, wherein the preparation container (3, 3',
3'') has the at least one sterile filter (22) or the at least one
virus filter or the at least one combination of a sterile filter
and a virus filter.
9. The device of claim 7, the preparation container (3, 3', 3'') a
pad, on or in which the sterile filter or the virus filter or the
combination of the sterile filter and the virus filter is
arranged.
10. The device of claim 7, wherein the preparation container (3,
3', 3'') and the receiving container (13, 13', 13'') are welded to
one another by way of a hose connection.
11. The device of claim 7, wherein at least one of the preparation
container (3, 3', 3'') and the receiving container (13, 13', 13'')
has at least one sensor for determining a parameter of the prepared
substance mixture.
12. The device of claim 7, the at least one sterile filter (22),
the at least one virus filter or the at least one combination of a
sterile filter and a virus filter is connected fixedly to the
receiving container (13, 13', 13'').
13. The device of claim 12, further comprising a mixing nozzle
connected to the receiving container or to the at least one sterile
filter (22), the at least one virus filter or the at least one
combination of a sterile filter.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation-in-part of
PCT/EP2012/001170, which claims priority on DE 10 2011 016 767.6,
filed Apr. 12, 2011, the disclosures of which are incorporated
herein by reference.
BACKGROUND
[0002] 1. Field of the Invention
[0003] The invention relates a method that includes arranging a
preparation container already made up with ingredients in a
receptacle of a device, feeding a fluid from a storage container
into the preparation container via a feed line, preparing the
ingredients with the fluid into a substance mixture, and removing
the substance mixture from the preparation container into a
receiving container via a discharge line. The invention also
relates to a device that includes a preparation container with
ingredients that can be arranged in a receptacle, a storage
container with a fluid that can be fed in a monitored manner to the
preparation container via a feed line, and a receiving container
that communicates with the preparation container via a discharge
line.
[0004] 2. Description of the Related Art
[0005] In the pharmaceutical and biopharmaceutical sector, in
particular in the preclinical or clinical sector, and also in
research and development, it is often necessary to prepare small
volumes of buffers and media. The buffers and media are often
prepared as already made up in accordance with predetermined
formulations, which require careful and relatively time-consuming
handling by the specialist personnel. It is particularly important
in this respect to prepare substance mixtures that are made to
conform to the volumes, concentrations and components or media
required by the final consumer.
[0006] For example, WO 2010/125329 A1 discloses a device and a
method for the portioned preparation of beverages, in particular
for the preparation or brewing of coffee. This device consists of a
preparation container with ingredients, that is coffee powder, that
can be arranged in a receptacle of the known device, a storage
container with a fluid, that is water, which is fed in a monitored
manner to the preparation container via a feed line. The water that
is fed to the preparation container in a heated form brews the
coffee powder mixture, which is fed as a prepared substance
mixture, that is as coffee, to a receiving container, that is a
coffee cup, via a discharge line.
[0007] The preparation container is in this case formed as a closed
capsule or cartridge, which contains the substance mixture to be
prepared.
[0008] There are, however, also known devices that use a so-called
pad instead of a capsule or cartridge.
[0009] The object of the invention is to provide a device and a
method with which the preparation of mixtures of pharmaceutical or
biopharmaceutical substances can be made possible even with
prescribed small or medium volumes, concentrations and media or
components that are easily and reliably made to suit the final
consumer.
SUMMARY OF THE INVENTION
[0010] This object is achieved by the use of a device for preparing
mixtures of pharmaceutical or biopharmaceutical substances,
comprising a preparation container with ingredients that can be
arranged in a receptacle, a storage container with a fluid that can
be fed in a monitored manner to the preparation container via a
feed line, and a receiving container that communicates with the
preparation container via a discharge line.
[0011] A storage container should also be understood as meaning a
fluid preparation system and, if the fluid is water, also a water
preparation system for analytically pure water, as sold for example
by Sartorius AG of Gottingen under the name Arium.RTM.. Other
systems that may be used here are those that produce water for
injection purposes. Such systems could be designed for example in
the form of multicolumn distillation or falling film
evaporation.
[0012] It has not so far occurred to a person skilled in the art to
consider devices and methods such as those known for the
preparation of beverages, such as coffee for example, for the
preparation of mixtures of pharmaceutical or biopharmaceutical
substances, which must take place under high-purity, sterile
conditions.
[0013] Adaptation of known devices known for the use or preparation
of mixtures of pharmaceutical or biopharmaceutical substances makes
it possible even under high-purity, sterile conditions to prepare
mixtures of pharmaceutical or biopharmaceutical substances
relatively quickly, reliably and easily from small to medium
amounts or volumes, in prescribable concentrations and media or
components, that are made to suit the final consumer. In principle,
this device is also suitable for larger amounts or volumes.
[0014] The invention preferably involves the use of the device for
the preparation of medicaments that are individual to a
patient.
[0015] The device preferably has a sterile filter or a virus filter
or a combination of a sterile filter and a virus filter in the feed
line to the preparation container and/or in the discharge line. As
a result, it is ensured that only sterile and/or virus-free fluid
is fed to the preparation container and only sterile and/or
virus-free prepared substance mixture is fed to the receiving
container.
[0016] The preparation container may be formed as a cartridge or a
capsule. A cartridge or capsule may in this case have both the feed
line and the discharge line on one side. However, it is also
possible to use a pad or membrane pad as the preparation container.
If a membrane pad is used, the feed line and the discharge line are
arranged on opposite sides of the pad.
[0017] It is also possible to feed ingredients individually to the
preparation container in the device from a plurality of storage
containers. In principle, it is also possible to arrange two or
more preparation containers next to one another in a parallel
arrangement or one behind the other in a series arrangement. The
preparation containers may be connected to one another by way of
hose connections, which are for example welded in a sterile
manner.
[0018] The preparation container may have a mixing arrangement that
facilitates the preparation process. The mixing arrangement may in
this case also be formed by mixing nozzles. The preparation
container or the receiving container may also be vibrated in a
vibrating device for the creation of a mixing process.
[0019] The device for the preparation of mixtures of pharmaceutical
or biopharmaceutical substances preferably comprises a preparation
container with ingredients that can be arranged in a receptacle, a
storage container with a fluid that can be fed in a monitored
manner to the preparation container via a feed line, a receiving
container that communicates with the preparation container via a
discharge line, and a sterile or virus filter or a combination
thereof that may be arranged upstream or downstream of the
preparation container.
[0020] The preparation container may have the at least one sterile
or virus filter or a combination thereof. This filter or
combination of filters may be arranged at inlet and/or outlet
opening(s), inside and/or outside the preparation container.
[0021] In this respect, the preparation container may also be
formed as a pad, on or in which a sterile filter is arranged.
[0022] The preparation container and the receiving container may be
connected to one another by way of a hose connection or may be
connected to one another, for example by sterile welding. Thus, the
preparation container could have on the output side and the
receiving container (for example a bag) could have on the input
side a respective welded hose, the free ends of which are welded to
one another in a sterile manner in a welding unit.
[0023] A filter device may be on the receiving container there and
may have a mixing nozzle that ends in the receiving container.
[0024] The receiving container with the ingredients may be
connected to the filter for example by way of piercing.
[0025] The bioreactor could, for example, be connected to a
controlling unit that controls a mixing operation and/or carries
out pH measurements, conductivity measurements or other
measurements or tests (release tests for media etc.).
[0026] The receiving container may be welded or fixedly connected
directly to a sterile and/or virus filter or a combination of a
sterile filter and a virus filter. The filter may be sterilized
together with the receiving container. The receiving container may
also be formed inter alia as a bag or bioreactor.
[0027] The receiving container may be connected releasably to a
sterile and/or virus filter or a combination of a sterile filter
and a virus filter.
[0028] The preparation container may be welded directly to a
sterile and/or virus filter or a combination of a sterile filter
and a virus filter.
[0029] The receiving container may include a mixing device of its
own.
[0030] The preparation container and/or the receiving container may
have at least one sensor for determining a parameter of the
prepared substance mixture. In this respect, the pH value, the
temperature, the conductivity or other parameters may be measured
and, if appropriate, regulated by way of a controlling and
monitoring unit. It is also possible to arrange a biochip, for
example for determining sterility, in the preparation container
and/or receiving container.
[0031] The invention also relates to a method for preparing
mixtures of pharmaceutical or biopharmaceutical substances
comprising the steps:
a) arranging a preparation container already made up with
ingredients in a receptacle of a device, b) feeding a fluid from a
storage container into the preparation container via a feed line,
c) preparing the ingredients with the fluid into a substance
mixture, and d) removing the substance mixture from the preparation
container into a receiving container via a discharge line.
[0032] The method step c) may be performed in a bag or
bioreactor.
[0033] Adaptation of known methods for preparing mixtures of
pharmaceutical or biopharmaceutical substances makes it possible,
even under high-purity and/or sterile conditions, to prepare
mixtures of pharmaceutical or biopharmaceutical substances
relatively quickly, reliably and easily in small to medium amounts
or volumes, in prescribable concentrations and media or components,
that are made to suit the final consumer.
[0034] The feed line may also comprise a filter, for example a
sterile filter. Similarly, the removal of the substance mixture may
take place via such a filter. The filter may also be attached here
directly to the receiving container (for example also be welded to
it). Furthermore, the filter may include a mixing nozzle on the
output side.
[0035] The already made up preparation container is closed off from
its surroundings and is only connected to the feed line and the
discharge line when it is received by the device, for example by
piercing with a piercing spike.
[0036] Use of the already made up preparation container ensures the
correct dosage of the ingredients.
[0037] The invention also relates to a method comprising the
following steps:
a) arranging a preparation container in a receptacle of a device,
b) feeding ingredients from a plurality of storage containers into
the preparation container, c) feeding a fluid from a storage
container into the preparation container via a feed line, d)
preparing the ingredients with the fluid into a substance mixture,
and e) removing the substance mixture from the preparation
container into a receiving container via a discharge line for the
preparation of mixtures of pharmaceutical or biopharmaceutical
substances.
[0038] Feeding ingredients from a plurality of storage containers
into the receiving container means that individual preparation with
different components is possible or a variable composition of the
substance mixture is possible while using the same preparation
container.
[0039] The methods may be used for the preparation of medicaments
that are individual to a patient, such as infusions or cytostatics
or parenterals for example. Similarly, preparation of artificial
blood, synthetic blood or blood substitute, such as
hemoglobin-based blood substitutes or perfluorocarbons, for
example, is possible.
[0040] The method may further include using a reading unit for
reading out a coding of the preparation container after arranging
the preparation container in the receptacle of a device and then
calling up from a memory parameters that are necessary for carrying
out the method and making the coding and those parameters available
to a monitoring and controlling unit. Thus automated preparation of
the substance mixture is easy and reliable and at the same time
makes an individual composition possible. Similarly, an
identification can be implemented with the aid of electromagnetic
waves (RFID) or other identification mechanisms.
[0041] Further details of the invention emerge from the following
detailed description and the accompanying drawings, in which
preferred embodiments of the invention are illustrated by way of
example.
BRIEF DESCRIPTION OF THE DRAWINGS
[0042] FIG. 1 is a schematic representation of a device for the
preparation of mixtures of pharmaceutical or biopharmaceutical
substances.
[0043] FIG. 2 is a side view of a preparation container.
[0044] FIG. 3 is a view from below of the container of FIG. 2 from
direction III.
[0045] FIG. 4 is a schematic representation of a further device for
the preparation of mixtures of pharmaceutical or biopharmaceutical
substances with a sterile filter in the discharge line of the
preparation container.
[0046] FIG. 5 is a further schematic representation of a device for
the preparation of mixtures of pharmaceutical or biopharmaceutical
substances with a plurality of storage containers.
[0047] FIG. 6 is a schematic representation of a further device for
the preparation of mixtures of pharmaceutical or biopharmaceutical
substances with a sterile filter linked directly to receiving
container.
[0048] FIG. 7 is a schematic representation of a further device for
the preparation of mixtures of pharmaceutical or biopharmaceutical
substances with a sterile filter linked to receiving container via
a tube.
[0049] FIG. 8 is a schematic representation of a further device for
the preparation of mixtures of pharmaceutical or biopharmaceutical
substances with a sterile filter linked directly to the preparation
container via a tube.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0050] A device 1 substantially consists of a receptacle 2 for a
preparation container 3, a storage container 4 and a controlling
and monitoring unit 5.
[0051] In the exemplary embodiment of FIG. 1, the receptacle 2 is
connected to the storage container 4 by way of a feed line 6. A
regulating valve 7 is arranged in the feed line 6 and is monitored
by the controlling and monitoring unit 5. The receptacle 2 has an
upper side 8 facing the preparation container 3, and a piercing
spike 9 is provided on the upper side 8. After the placing of the
preparation container 3 onto the receptacle 2, a fluid 10 located
in the storage container 4 can be fed to the preparation container
3 via the piercing spike 9 and a prepared substance mixture 11 can
be discharged into a receiving container 13 via a discharge line
connected to the piercing spike 9. The fluid 10 to be fed to the
preparation container 3 may be monitored by a sensor S and
temperature-controlled in a temperature-controlling device 14 of
the controlling and monitoring unit 5. The preparation container 3
has an underside 15 facing the upper side 8 of the receptacle 2,
and a coding 16, for example as a barcode, is provided on the upper
side 8 of the receptacle 2. The coding 16 is read out by a reading
unit 17 and fed to the controlling and monitoring unit 5. The
coding 16 is used by the controlling and monitoring unit 5 to call
up from a memory, which is not represented any further, the
parameters necessary for carrying out the method and to use them
for carrying out the preparation method.
[0052] The exemplary embodiment of FIG. 4 shows a device 1' with a
preparation container 3' that has a mixing arrangement 18 therein.
The mixing arrangement 18 is illustrated as including an agitator
19 with an agitating shaft 20, but could, for example, have a
magnetic agitator with a magnetic drive. Fluid or other
ingredients, such as powder, can be fed via the mixing arrangement.
A sterile filter 22 is arranged in the discharge line 12' upstream
of the receiving container 13', which is formed as a disposable bag
21. The agitator may alternatively be attached in the bag or in the
preparation container 3'. Sensors S may be arranged in the
preparation container 3' and/or in the receiving container 13' to
monitor conditions therein.
[0053] Consequently, a method can be carried out for example with
the following steps:
a) arranging the preparation container 3' in the receptacle of the
device 1', b) monitored automatic feeding of ingredients and a
fluid (for example water) 10 from corresponding storage containers
into the preparation container 3', c) preparing the ingredients
with the fluid into a substance mixture, the substance mixture
being thoroughly mixed by the mixing arrangement 18 or the agitator
19 thereof, d) measuring prescribed parameters (for example
conductivity, pH value and temperature) and approval e) removing
the substance mixture from the preparation container 3' via the
sterile filter 22 (for example by breaking through a barrier) and
via the discharge line 12' into the receiving container 13', f)
printing out a label and adhesive attachment to the preparation
container, and g) closing the preparation container 3' or the
disposable bag 21 (for example by welding and detachment of the
discharge line hose 12').
[0054] In the exemplary embodiment of FIG. 5, the device 1'' has a
preparation container 3'' with a mixing arrangement 18''. Arranged
upstream of the preparation container 3'' in the exemplary
embodiment 4 are a plurality of storage containers 23, 24, 25, 26,
via which the various media or ingredients can be fed by the
controlling and monitoring unit 5'' and assigned regulating valves
7''. The fluid 10'' from the storage container 4'' is fed from the
preparation container 3'' likewise via a regulating valve 7''.
Correspondingly, the prepared substance mixture 1'' is fed to a
receiving container 13'' via a discharge line 12''. The storage
containers 23, 24, 25, 26 can be manually selected both by way of
the controlling and monitoring unit 5'' and by way of a touchscreen
27.
[0055] FIG. 6 schematically illustrates a further embodiment of a
device in accordance with the invention. The device 101 shown in
FIG. 6 has a receiving container 113 in the form of a flexible
disposable bag. A hose 106 extends from a storage container (not
shown) similar to the storage container 4 shown in FIG. 1 and a
preparation container similar to the preparation container 3 shown
in FIG. 1. A controlling and monitoring unit 105 communicates with
the hose 106 for controlling the flow of fluid through the hose 106
and toward the receiving container 113. A storage container 124 is
incorporated into the hose 106 and may define a capsule with powder
that is to be fed into the fluid directed to the receiving
container 113. A sterile filter 122 is linked directly to the
receiving container 113 for filtering fluid flowing through the
hose 106 and into the receiving container 113. Coded indicia 116,
such as barcodes, are provided on the storage container 124 and the
sterile filter 122 and can be read by a code reader, as described
with respect to the device 1 illustrated in FIG. 1. A mixing nozzle
126 is provided for mixing and/or agitating the fluid mixture fed
into the receiving container 113. Additionally, or alternatively, a
mixing device 118, such as an agitator, may be provided within the
receiving container 113. At least one sensor S is provided in the
receiving container 113 for monitoring conditions therein. The
device 101 function substantially as the other embodiments and has
the advantages described above with respect to the other
embodiments.
[0056] FIG. 7 schematically illustrates a further embodiment of a
device in accordance with the invention. The device 201 shown in
FIG. 7 has a receiving container 213 in the form of a flexible
disposable bag. A hose 206 extends from a storage container (not
shown) similar to the storage container 4 shown in FIG. 1 and a
preparation container similar to the preparation container 3 shown
in FIG. 1. A controlling and monitoring unit 205 communicates with
the hose 206 for controlling the flow of fluid through the hose 206
and toward the receiving container 213. A storage container 224
communicates with the hose 206 near the receiving container 213,
and may define a capsule with powder that is to be fed into the
fluid directed to the receiving container 213. A sterile filter 222
is linked to the receiving container 213 via a tube 223 for
filtering fluid flowing into the receiving container 213. Coded
indicia 216, such as barcodes, are provided on the container 224
and the sterile filter 222 and can be read by a code reader, as
described with respect to the device 1 illustrated in FIG. 1. A
mixing nozzle 224 is provided for mixing and/or agitating the fluid
mixture fed into the receiving container 213. Additionally, or
alternatively, a mixing device 218, such as an agitator, may be
provided within the receiving container 213. At least one sensor S
is provided in the receiving container 213 for monitoring
conditions therein. The device 201 function substantially as the
other embodiments and has the advantages described above with
respect to the other embodiments.
[0057] FIG. 8 schematically illustrates a further embodiment of a
device 301. The device 301 is similar to the device 1 shown in FIG.
1. More particularly, the device 301 includes a preparation
container 303 that is in communication with a storage container 304
via a feed line 306. A regulating valve 307 is arranged in a feed
line 306 extending from the storage container 304 to the
preparation container 303. A storage container 324 also is in
communication with the feed line 306 and may contain a powder that
is fed into the fluid 310 flowing through the feed line 306 and
toward the preparation container 303. The device 301 differs from
the preceding embodiments in that a sterile filter 322 is linked to
the preparation container 303 via a tube 323. Coded indicia (e.g.
barcodes) and readers are provided as in the other embodiments.
This embodiment is particularly useful for larger units.
[0058] Of course, the embodiments discussed in the specific
description and shown in the figures only represent illustrative
exemplary embodiments of the present invention. In the light of the
disclosure here, a person skilled in the art is offered a wide
spectrum of possibilities for variation.
* * * * *