WO2019243258A1

WO2019243258A1 - Sales unit for a fluid processing system and method for preparing said system to be put into use

Info

Publication number: WO2019243258A1
Application number: PCT/EP2019/065884
Authority: WO
Inventors: Johannes WORTMEYER
Original assignee: Sartorius Stedim Biotech Gmbh
Priority date: 2018-06-19
Filing date: 2019-06-17
Publication date: 2019-12-26

Abstract

The invention relates to a sales unit (10) for an inflatable fluid processing system (12) having a plurality of fluid processing components (16) which are fluidically, reversibly interconnected and which each have a gas-tight wall and an interior enclosed by the wall, comprising: - the fluid processing system (12) per se and - a flexible primary packaging (14) that encloses the fluid processing system (12) and acts as a sterile barrier, said primary packaging having a wall and an interior containing the fluid processing system (12). The invention is characterised in that the wall of the primary packaging (14) has a first opening (26) which is gas-conductively connected to the interior of the fluid processing system (12) and which is gas-tightly sealed off from the gap between the walls of the fluid processing system (12) and the primary packaging (14), wherein the first opening (26) is connected to a sterile interface (18, 24) for the sterile shielding of the fluid processing system (12) from the environment outside the primary packaging (14). The invention further relates to two methods for preparing a fluid processing system (12) provided in the form of such a sales unit (10) to be put into use.

Description

Sales unit for a fluid processing system and method for preparing for its commissioning

description

Field of the Invention

The invention relates to a sales unit for an inflatable

Fluid processing system with a plurality of fluid processing components, which are fluid-conducting, reversibly connected to each other and each have a gas-tight wall and an interior surrounded by the wall

- the fluid processing system as such and

a flexible primary packaging surrounding the fluid processing system, acting as a sterile barrier, with a wall and an interior containing the fluid processing system.

The invention further relates to a method for preparing the commissioning of a fluid processing system provided in the form of such a sales unit.

State of the art

In the modern biotechnological and pharmaceutical industry, the use of so-called disposables, i.e. Components for fluid processing intended and designed for single use have been established. The term processing is to be understood broadly in the present context and includes the actual treatment of fluids, such as their filtering or mixing, but also their mere conduction or storage, so that the term fluid processing components, for example, filtration devices, valves, hose lines, bag-like

Bioreactors etc. includes. From such fluid processing components

composite, more or less complex fluid processing systems often offered pre-assembled. To create storable and transportable

The preassembled unit has proven its worth

Fluid processing system in a flexible, closed and acting as a sterile barrier primary packaging, for example a transparent PE film. The primary packaging is typically only removed immediately before use. This includes, in particular, the connection of the fluid processing system, which has been freed from the primary packaging, to an integrity test device, with which the fluid processing system is tested for leaks before the fluid intended for the actual processing is applied, or before it is installed in a larger fluid processing system. For this purpose, the fluid processing system must be inflatable, because the integrity test is carried out by applying compressed air to the interior of the system through which fluid is actually processed, with the resulting excess pressure being maintained when the system is intact. In the event of a leak, on the other hand, there is a pressure drop that is detected by suitable sensors on the

Integrity test device can be determined. In this sense, the term "inflatable" is to be understood, which does not necessarily imply a significant elasticity of the system walls. In order to be able to be subjected to such a compressed air-based integrity test, the fluid processing systems contained in their respective primary packaging are typically designed as (with the exception of a compressed air supply opening) self-contained systems. In particular, later ends are open ends due to gas-tight caps or gas-tight

Sterile connectors completed.

The disadvantage here is that the entire

Fluid processing system must be discarded, since the system interior at the leak has come into contact with the non-sterile environment, so that contamination cannot be excluded. Especially in cases where the leak is not due to the perforation of one of the walls

Fluid processing components, but only on a carelessly closed or loosened connection between two

Fluid processing components is based, this seems particularly annoying, since such reversible connections - unlike perforated walls - would generally be repairable. task

It is the object of the present invention to provide an improved sales unit for fluid processing systems which, in particular, offers the possibility, in the event of an integrity test failing, because of fundamentally repairable damage to the system, to actually repair it, instead of discarding the entire system in any case have to.

Statement of the invention

This object is achieved in connection with the features of the preamble of claim 1 in that the wall of the primary packaging has a first breakthrough, which is in gas-conducting connection to the interior of the fluid processing system and against the space between the walls of the

Fluid processing system and the primary packaging is sealed gas-tight, the first opening being connected to a sterile interface for sterile shielding of the fluid processing system from the environment outside the primary packaging.

Advantageous methods for using sales units according to the invention, in particular in the context of the preparation for the commissioning of the respective

Fluid processing systems are given in claims 6 and 7.

Preferred embodiments are the subject of the dependent claims.

The basic idea of the invention is to modify the known primary packaging in such a way that a sterile connection of a compressed air source

Integrity test device can be made to the fluid processing system without first removing the primary packaging. That remains during the integrity test

The fluid processing system is therefore protected against contamination from the environment by the sterile barrier of the primary packaging. A leak in the fluid processing system therefore does not represent a connection between the interior of the system and the non-sterile environment. If the leak is a defect that can be repaired in principle, for example an incorrectly closed connection terminal between two Fluid processing components, these can be repaired "through the primary packaging". Repair tools, including the hands of a user, are attached in the usual way, but from outside the primary packaging, the flexible wall of the primary packaging being placed as a flexible intermediate layer between the element to be repaired and the repair tool. If the integrity of the system is determined in a further integrity test after the repair has been carried out, it can be used in a conventional manner, in particular after the primary packaging has been removed, despite the original fault and does not necessarily have to be discarded.

To achieve this, a first breakthrough is provided in the wall of the primary packaging. This first breakthrough, however, is in a gas-conducting connection to the interior of the fluid processing system, thus connecting it to the environment, which initially appears to be contraindicated. A connection of the

On the other hand, the first breakthrough does not create any space between the walls of the fluid processing system on the one hand and the primary packaging on the other. Rather, the first breakthrough and its connection to the interior of the fluid processing system are created in such a way that said

The space remains sealed gas-tight - both against the environment and against the interior of the fluid processing system. In spite of the connection between the inside of the building created by the first breakthrough

Fluid processing system and the environment the required sterility of the

To maintain the fluid processing system, it is further provided according to the invention that the first opening is in turn connected to a sterile interface which ensures the necessary sterile shielding of the (interior of the) fluid processing system from the environment outside the primary packaging. In other words, a completely contraindicated connection is first created, which is "corrected" by an additional measure with regard to the sterility of the fluid processing system. However, this complication of the entirety, which does not appear to be very intuitive, leads to the previously explained advantage which is achieved by the present invention.

The sterile interface mentioned can be implemented in different ways. In a first variant, it is provided that the sterile interface as a Fluid processing system is designed upstream of the fluid inlet or outlet side, sterile air filter arranged within the primary packaging. In other words, in addition to the actual fluid processing system, the primary packaging also envelops an additional sterile air filter. On the one hand, this is associated with said first breakthrough in the wall of the primary packaging. On the other hand, it is connected to a fluid inlet or outlet of the fluid processing system. In this way, the entry path for contamination created by the first breakthrough is closed before reaching the actual fluid processing system. To carry out the integrity test, an (unsterile) compressed air source can be connected to the first breakthrough and the test can be carried out in the usual way. Since any compressed air has to pass through the additional sterile air filter before reaching the fluid processing system, there is no risk of contamination of the system. Also the

Space between the fluid processing system and the wall of the

Primary packaging remains sterile. After passing the integrity test, if necessary after repairing a leak, the primary packaging and, if necessary or desired, the additional sterile air filter can be removed and that

Fluid processing system can be coupled in the usual way with a fluid connection of a larger system provided for this purpose.

In a second variant of the invention, it is provided that the sterile interface is designed as a sterile air filter forming a gas inlet or outlet of the fluid processing system. This variant therefore requires a fluid processing system that already contains a sterile air filter, for example as a ventilation outlet. This sterile air filter belonging to the fluid processing system as such is assigned a double function in the mentioned embodiment of the invention, namely its actual, original function as a component of the fluid processing system and, on the other hand, the additional function as a sterile interface. The integrity test is carried out as for the variant described above. After passing the integrity test, however, only the primary packaging is removed, whereas the sterile air filter as part of the fluid processing system with the others

Fluid processing components remains connected. The contamination of its side facing away from the system during the integrity test is not critical because this side is non-sterile even when the fluid processing system is operated as intended. In other words, the aforementioned variants of the invention enable a method for preparing the commissioning of a fluid processing system provided in the form of such a sales unit, comprising the steps:

- gas-conducting connection of the first opening to a compressed air source,

Introducing compressed air into the fluid processing system,

- Checking the fluid processing system for gas leakage into the primary packaging,

- In the event of gas leakage through a faulty connecting element between two fluid processing components: repairing the connecting element from outside the primary packaging, the wall of the primary packaging serving as a flexible intermediate layer between a repair tool and the

Connecting element works.

In a third variant of the invention, it is provided that the sterile interface is connected upstream of the fluid processing system on the fluid inlet or outlet side

Sterile connector is formed. Such a sterile connector, which can be arranged in the first breakthrough itself or connected to it with an outwardly projecting piece of hose, creates the possibility of using an external sterile air filter to supply the compressed air source required for carrying out the integrity test

Connect fluid processing system. The non-sterile side of the sterile air filter is connected directly to the compressed air source. Its sterile side can be connected sterile to the first opening by means of said sterile connector, the connection to the fluid processing system of which had been kept sterile by said sterile connector during transport and storage. After passing the integrity test, if necessary after a leak repair, the actual commissioning is carried out exactly as in the case of the above-mentioned variant.

This variant of the invention thus enables a method for preparing the

Commissioning of one provided in the form of such a sales unit

Fluid processing system comprising the steps:

- gas-conducting connection of the first opening with an external sterile air filter,

- gas-conducting connection of the external sterile air filter to a compressed air source,

- Introducing compressed air into the fluid processing system via the external

Sterile air filter,

- Checking the fluid processing system for gas leakage into the primary packaging, - In the event of gas leakage through a faulty connecting element between two fluid processing components: repairing the connecting element from outside the primary packaging, the wall of the primary packaging serving as a flexible intermediate layer between a repair tool and the

Connecting element works.

In a development of the invention, the procedure is that the wall of the

Primary packaging has further openings, which are gas-conducting connection to the interior of the fluid processing system and are sealed gas-tight against the space between the walls of the fluid processing system and the primary packaging, the further openings on the one hand with a fluid or gas inlet or outlet of the fluid processing system and on the other hand are connected to a sterile connector. In other words, in addition to the first opening and the associated connection, further openings and connections are provided in the manner of the third variant of the present invention. If all inputs and outputs of the fluid processing system are guided outside of the primary packaging in this way, it is possible to carry out the actual commissioning of the system without first removing the primary packaging. The work step saved here can be associated with significant time and thus cost savings, particularly in the case of large and / or complex systems.

Further features and advantages of the invention result from the following special description and the drawing.

Brief description of the drawing

Show it:

FIG. 1: a schematic representation of a first embodiment of a sales unit according to the invention,

FIG. 2 shows a schematic illustration of a second embodiment of a sales unit according to the invention, Figure 3 is a schematic representation of a third embodiment of a sales unit according to the invention and

FIG. 4 shows a further development of the embodiment from FIG. 1.

Detailed description of preferred embodiments

The same reference symbols in the figures indicate the same or analog elements.

Figure 1 shows a highly schematic representation of an inventive

Sales unit 10. The sales unit 10 comprises a fluid processing system 12, which is wrapped in a flexible primary packaging 14. The

In the illustrated embodiment, fluid processing system 12 consists of

Essentially consisting of three fluid processing components 16, the specific function of which is not relevant in the context of the present invention. For example, it can be filtration arrangements, reactor vessels, hoses, valves, etc. The

In all embodiments of the invention, fluid processing components 16 are preferably manufactured as components designed and designed for single use, preferably made of plastic and particularly preferably at least in regions made of flexible plastic.

In addition to the fluid processing system 12, a sterile air filter 18 not belonging to the fluid processing system 12 is additionally contained in the interior of the primary packaging 14 in the embodiment shown. The fluid processing components 16 are connected to one another and to the sterile air filter 18 by means of connecting flanges 20 which are clamped together by means of clips 22. In the illustrated embodiment, the fluid processing system 12 also has two as

Sterile connectors 24 formed external connections, via which it can be connected to corresponding connections of an external fluid processing system during commissioning. The sterile connectors 24 in particular form a gas-tight seal of the fluid processing system 12.

The sterile air filter 18 has a further connecting flange 20, one

Breakthrough 26 penetrated sealed in the wall of the primary packaging 14. On in this way the non-sterile side of the sterile air filter 18 is in contact with the surroundings of the

Primary packaging 14 in connection. His sterile side, however, is inside the

Primary packaging 14 connected to the fluid processing system 12. The

Breakthrough 26 in the wall of the primary packaging 14 is sealed in any case so that no contact between the surroundings of the primary packaging 14 and the

There is a gap between its wall and the fluid processing system 12. The fluid processing system 12 is therefore in a sterile atmosphere within the primary packaging 14.

Such a sales unit 10 is suitable to be connected to an external compressed air source 28 without opening the primary packaging 14 via the connection flange 20 of the sterile air filter 18 projecting through the opening 26. The compressed air source 28 can be used to apply compressed air to the fluid processing system 12, and any leaks can be measured using a suitable sensor

Pressure drop can be detected. If such a pressure drop results, for example, from an incorrectly closed clamp 22, this can easily be repaired through the flexible wall of the primary packaging 14. same for

of course for other externally repairable damage or errors.

As soon as the fluid processing system 12 has passed the integrity test, possibly after a repair, the primary packaging 14 can be removed. The

The fluid processing system 12 can then be separated from the sterile air filter 18 and installed in a larger fluid processing system via the connection flange 20 that has become free and the sterile connectors 24.

FIG. 2 shows a second embodiment of the invention, which does not differ in construction from the embodiment of FIG. 1. A functional difference is, however, that the sterile air filter 18 is part of the

Fluid processing system 12 and therefore itself is a fluid processing component 16. The connecting flange 20 used in the integrity test to connect the compressed air source 28 and penetrating the opening 26 in the wall of the primary packaging 14 serves in the operating state of the fluid processing system 12, i.e. built into a larger fluid processing plant, typically as one

Vent outlet, which need not be sterile. Hence its inevitable Contamination during storage and transport of the sales unit 10 is not critical. For the rest, reference can be made in full to what has been said above regarding the embodiment of FIG. 1.

FIG. 3 shows a third embodiment of the sales unit 10 according to the invention. Here the opening 26 in the wall of the primary packaging 14 is sealed and penetrated by a sterile connector 24. In the integrity test, the compressed air source 28 is connected to this sterile connector 24 via an external sterile air filter 18.

This takes place in particular via a corresponding sterile connector 24 of the external sterile air filter 18. For the rest, reference can be made to what has been said above with regard to FIGS. 1 and 2.

Finally, FIG. 4 shows a further development of the embodiment from FIG. 1. In this embodiment, the sterile connectors 24 also protrude

Fluid processing components 16 the wall of the primary packaging 14. This variant allows the fluid processing system 12 to be installed in a larger fluid processing system without first removing the primary packaging 14.

Of course, the embodiments discussed in the specific description and shown in the figures represent only illustrative embodiments of the present invention. In the light of the disclosure herein, those skilled in the art will understand a wide variety

Spectrum of possible variations given.

LIST OF REFERENCE NUMBERS

10 sales unit

12 fluid processing system

14 primary packaging

16 fluid processing component

18 sterile air filters

20 connecting flange

22 bracket

24 sterile connector

26 breakthrough in the wall of 14

28 Compressed air source

Claims

claims

1. Sales unit (10) for an inflatable fluid processing system (12) with a plurality of fluid processing components (16) which are fluid-conducting, reversibly connected to one another and each have a gas-tight wall and an interior surrounded by the wall

- The fluid processing system (12) as such and

- A surrounding the fluid processing system (12) as a sterile barrier

active, flexible primary packaging (14) with a wall and an interior containing the fluid processing system (12),

characterized,

that the wall of the primary packaging (14) has a first opening (26) which is in gas-conducting connection to the interior of the

Stands fluid processing system (12) and is sealed gas-tight against the space between the walls of the fluid processing system (12) and the primary packaging (14),

the first opening (26) being connected to a sterile interface (18; 24) for sterile shielding of the fluid processing system (12) from the environment outside the primary packaging (14).

2. sales unit (10) according to claim 1,

characterized,

that the sterile interface is designed as a sterile air filter (18) arranged upstream of the fluid processing system (12) on the fluid inlet or outlet side and arranged within the primary packaging (14).

3. sales unit (10) according to claim 1,

characterized,

that the sterile interface acts as a gas inlet or outlet for the

Fluid processing system (12) forming sterile air filter (18).

4. sales unit (10) according to claim 1,

characterized,

that the sterile interface is designed as a sterile connector (24) connected upstream of the fluid processing system (12) on the fluid inlet or outlet side.

5. sales unit (10) according to any one of the preceding claims,

characterized,

that the wall of the primary packaging (14) has further openings which are in gas-conducting connection to the interior of the fluid processing system (12) and against the space between the walls of the

Fluid processing system (12) and the primary packaging (14) are sealed gas-tight,

the further openings being connected on the one hand to a fluid or gas inlet or outlet of the fluid processing system (12) and on the other hand to a sterile connector (24).

6. Procedure for preparing for commissioning one in the form of a

Sales unit (10) according to one of claims 2 to 3 provided

Fluid processing system (12) comprising the steps:

- Gas-conducting connection of the first opening (26) with one

Compressed air source (28),

Introducing compressed air into the fluid processing system (12),

- Check the fluid processing system (12) for gas leakage into the

Primary packaging (14),

- In the event of gas leakage through a faulty connecting element (20, 22) between two fluid processing components (16): repair the

Connecting element (20, 22) from outside the primary packaging (14), the wall of the primary packaging (14) acting as a flexible intermediate layer between a repair tool and the connecting element (20, 22).

7. Procedure for preparing for commissioning one in the form of a

Sales unit (10) provided according to claim 4

Fluid processing system (12) comprising the steps: - Gas-conducting connection of the first opening (26) with an external

Sterile air filter (18),

- Gas-conducting connection of the external sterile air filter (18) with one

Compressed air source (28),

Introducing compressed air into the fluid processing system (12) via the external sterile air filter (18),

- Check the fluid processing system (12) for gas leakage into the

Primary packaging (14),