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WO2025045990A1 - Système et procédé de test d'intégrité de récipient - Google Patents

Système et procédé de test d'intégrité de récipient Download PDF

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Publication number
WO2025045990A1
WO2025045990A1 PCT/EP2024/074154 EP2024074154W WO2025045990A1 WO 2025045990 A1 WO2025045990 A1 WO 2025045990A1 EP 2024074154 W EP2024074154 W EP 2024074154W WO 2025045990 A1 WO2025045990 A1 WO 2025045990A1
Authority
WO
WIPO (PCT)
Prior art keywords
test gas
container
chamber
test
cci
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2024/074154
Other languages
English (en)
Inventor
Lars ABEL
Christian PROFF
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Hoffmann La Roche Inc
Original Assignee
F Hoffmann La Roche AG
Hoffmann La Roche Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by F Hoffmann La Roche AG, Hoffmann La Roche Inc filed Critical F Hoffmann La Roche AG
Publication of WO2025045990A1 publication Critical patent/WO2025045990A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/20—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material
    • G01M3/22—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators
    • G01M3/226—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators
    • G01M3/229—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material for pipes, cables or tubes; for pipe joints or seals; for valves; for welds; for containers, e.g. radiators for containers, e.g. radiators removably mounted in a test cell
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/04—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point
    • G01M3/20—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material
    • G01M3/202—Investigating fluid-tightness of structures by using fluid or vacuum by detecting the presence of fluid at the leakage point using special tracer materials, e.g. dye, fluorescent material, radioactive material using mass spectrometer detection systems
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
    • G01M3/00—Investigating fluid-tightness of structures
    • G01M3/02—Investigating fluid-tightness of structures by using fluid or vacuum
    • G01M3/26—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors
    • G01M3/28—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds
    • G01M3/2807—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds for pipes
    • G01M3/2815—Investigating fluid-tightness of structures by using fluid or vacuum by measuring rate of loss or gain of fluid, e.g. by pressure-responsive devices, by flow detectors for pipes, cables or tubes; for pipe joints or seals; for valves ; for welds for pipes using pressure measurements

Definitions

  • the present invention relates to a container closure integrity (CCI) testing system and a method of CCI testing a container.
  • CCI testing method and system can be used for testing tightness of a stopper closure of a container, wherein the container has a hollow interior, an outlet, an open end and a stopper arranged to close the hollow interior.
  • the container can particularly be a primary packaging and be filled or intended to be filled with a pharmaceutical, chemical or drug substance.
  • integrity of involved container and primary packagings in which the substances are filled, is of high importance.
  • integrity of a container or primary packaging generally indicates the ability of keeping a content or substance inside the respective container or packaging and of keeping detrimental environmental contaminants outside the respective container or packaging.
  • Leaks are typically perceived as holes or cracks of a certain diameter and length. Leakage may be a measure of gas flow (in mass or volume or units) that passes through a leak path under specific conditions. Leakage of 1 [mbar x I I sec] is given when the pressure in a closed container of 1 liter rises or falls within 1 sec by 1 mbar.
  • SUBSTITUTE SHEET (RULE 26) of syringes, cartridges and vials, stoppers may undergo certain movements or deformations, or the stoppers may be or get impaired such that tightness may be affected.
  • test container closure integrity is to provide a test gas into the interior of the container and to measure the test gas outside the container or vice versa.
  • a test gas For example, an open end or back side of a syringe may be exposed to a test gas at a specific pressure and concentration.
  • test gas concentration is measured at an outlet of the syringe.
  • test gas involving CCI testing methods may be comparably quick and useful, they still have some downsides which decrease accuracy, reliability and reproducibility.
  • the pressure of the test gas decreases when test gas passes the stopper and exits the outlet.
  • the pressure difference between test gas side and the outlet side varies and the test gas signal varies accordingly.
  • Such varying pressure difference may affect accuracy of the measurements.
  • the invention is a container closure integrity (CCI) testing system to test or control physical container closure integrity of a container.
  • the container has a hollow interior, an outlet, an open end and a stopper arranged to close the hollow interior.
  • the container can be any suitable receptacle for receiving a chemical or pharmaceutical substance such as a drug substance.
  • a chemical or pharmaceutical substance such as a drug substance.
  • such containers often are used as primary packaging.
  • drug as used herein relates to a therapeutically active agent, also commonly called active pharmaceutical ingredient (API), as well as to a combination of plural such therapeutically active substances.
  • the term also encompasses diagnostic or imaging agents, like for example contrast agents (e.g. MRI contrast agents), tracers (e.g. PET tracers) and hormones, that need to be administered in liquid form to the patient.
  • diagnostic or imaging agents like for example contrast agents (e.g. MRI contrast agents), tracers (e.g. PET tracers) and hormones, that need to be administered in liquid form to the patient.
  • the chamber is coupled to the container holder to form an encasing of a second aperture being the other one of the open end of the container or the outlet of the container when the first aperture is received by the container holder. It has an exhaust outlet.
  • the test gas supply is coupled to the chamber.
  • conditioning gas in this connection relates to any suitable gas different from or not comprising test gas. It can be ambient air, an air-like gas, Nitrogen or a similar pure and particularly inert gas appropriate for the specific application of the CCI testing system.
  • the term “activate” in connection with the gas supplies can relate to configuring the respective gas supply to provide gas.
  • activation of the gas supplies can relate to opening a pressurized gas reservoir.
  • the valve arrangement can be embodied to activate the test gas supply and/or the conditioning gas supply by opening or closing respective test gas or conditioning gas reservoirs and/or a supply pipe.
  • the gas supplies can have pressurized reservoirs containing the respective gases and the valve arrangement opens and closes the reservoirs to allow efficient provision of the gases as the need may be.
  • the conditioning gas supply preferably houses the conditioning gas at a pressure higher than atmospheric pressure and preferably is configured to release the conditioning gas at about 6 bar.
  • the conditioning gas supply advantageously comprises a conditioning gas reservoir such as a pressurized tank or containment.
  • the test gas supply houses the test gas at a pressure higher than atmospheric pressure and is configured to release the test gas at about 1 .5 bar.
  • the CCI testing system comprises a flow regulation unit configured to determine an extent of flow into the chamber.
  • the flow regulation unit includes a flow meter or flow sensor to determine a dimension of the regulated flow. Like this, the flow can be verified and accurately adjusted, if required.
  • the CCI testing system comprises a control unit coupled to the test gas supply and the test gas detector.
  • the control unit can be coupled to the flow regulation unit to achieve an indirect coupling to the test gas supply and/or the conditioning gas supply, if any.
  • the control unit can be coupled to the test gas supply and the test gas detector as well as to other components by being in communication with these components.
  • coupling of the control unit can be embodied by a data transmission connection, wherein the data transmission can be established in one or both ways. Thereby, the data transmission connection can be a wired or a wireless connection.
  • the control unit allows to efficiently control and operate the CCI testing system or specific components thereof.
  • the control unit can be or comprise a computer.
  • the term "computer” relates to any electronic data processing device. It includes individual devices such as laptop computers, desktop computers, server computers, tablets, smartphones, systems embedded in other devices (embedded systems), or the like. It also covers combined devices or computer networks such as distributed system emit components in different locations.
  • computers are composed of various building blocks or components such as processors (CPU), permanent data storage devices with a recording medium such as a hard disk, flash memory or something similar, random access memories (RAM), read-only memory (ROM), communication adapters such as USB adapters, LAN adapters, WLAN adapters, Bluetooth adapters or the like, user interfaces such as keyboards, mice, touch screens, monitors, microphones, speakers, and other components.
  • Computers can be composed of the above components and/or other components in a broad variety of embodiments.
  • the computer can be configured in accordance with embodiments of the invention by comprising and running a specific software. Such software may comprise a set of commands affecting the computer to perform certain actions when being executed.
  • the control unit preferably is configured to apply a test cycle according to a test protocol. By implementing the test protocol in the control unit, an accurate and efficient test cycle can be achieved.
  • the test protocol preferably comprises a step of flushing the test gas through the chamber for a gassing duration.
  • the flushing of the test gas can be achieved by the control unit providing instructions or commands to the test gas supply and/or the valve arrangement and/or the flow regulation unit. Further, the control unit can receive information or data from the flow regulation unit in order to accurately control the flushing of the chamber with test gas.
  • the control unit can receive information or data from the flow regulation unit in order to accurately control the flushing of the chamber with test gas.
  • the test gas can be provided at a constant pressure to the second aperture of the container.
  • the gassing duration preferably is in a range of about 5 seconds to about 10 minutes and, advantageously, in a range of about 20 seconds to about 120 seconds.
  • flushing durations allow the test gas detector to generate a reliable and robust signal.
  • this accuracy of test gas detection can be comparably high and, still, the testing duration can be suitably or appropriately short or fast.
  • the control unit preferably is coupled to the valve arrangement, wherein the control unit is configured to adapt the valve arrangement to activate the test gas supply for the gassing duration to flush the test gas through the chamber.
  • the control unit is configured to adapt the valve arrangement to activate the test gas supply for the gassing duration to flush the test gas through the chamber.
  • the control unit preferably is configured to evaluate test gas measurements of the test gas detector collected during flushing the test gas through the chamber. Such evaluation may result in an assessment of the leakage situation of the container. In particular, a dimension of leakage can be determined and the container can be rated as to its conformity with certain standards.
  • the test protocol comprises a step of flushing conditioning gas through the chamber for a conditioning duration.
  • conditioning gas flushing allows for removing other gas such as test gas from the chamber.
  • disturbance of measurements or detection can be prevented or at least essentially lowered such that accurate operation and assessment can be achieved.
  • the conditioning duration preferably is in a range of about 5 seconds to about 20 seconds and advantageously is about 10 seconds. Such conditioning durations allow for a sufficient and efficient conditioning of the system.
  • control unit preferably is coupled to the valve arrangement, wherein the control unit is configured adapt the valve arrangement to activate the conditioning gas supply for the conditioning duration to flush the conditioning gas through the chamber.
  • control unit is configured adapt the valve arrangement to activate the conditioning gas supply for the conditioning duration to flush the conditioning gas through the chamber.
  • the control unit preferably is configured to adapt the valve arrangement to deactivate the conditioning gas supply when the test gas supply is activated and to adapt the valve arrangement to deactivate the test gas supply when the conditioning gas supply is activated.
  • a proper sequence of flushing can be achieved and the conditioning gas flushing can be separated from the test gas flushing.
  • the test protocol comprises a step of clearing a tight connection between the container holder and the test gas detector for a clearing duration.
  • the tight connection can be embodied by a channel, tube, pipe, hose and/or similar structure.
  • disturbance of detection or measurement by residuals in the tight connection e.g., stemming from earlier test cycles, can be prevented or essentially lowered.
  • the clearing duration preferably is in a range of about 10 seconds to about 30 seconds and particularly is about 20 seconds. Such clearing durations allow for a sufficient and efficient clearing of the system.
  • the clearing step comprises applying a subatmospheric pressure such as a vacuum to the tight connection.
  • a subatmospheric pressure such as a vacuum
  • Such vacuum application allows for efficiently clearing or preparing the system.
  • the container holder is configured to horizontally hold the container when receiving the first aperture.
  • Such horizontal arrangement can be particularly useful when flushing the test gas.
  • the control unit is coupled to the exhaust outlet and configured to selectively open and close the exhaust outlet.
  • the invention is a method of CCI testing a container to control physical container closure integrity of the container.
  • the method comprises the steps of: (i) obtaining a container having a hollow interior, an outlet, an open end and a stopper provided to close the hollow interior; (ii) mounting the container to a container holder by tightly receiving a first aperture being one of the outlet of the container or the open end of the container, wherein the container holder is tightly coupled to a test gas detector which is configured to detect test gas, such as Helium, exiting the first aperture when being received by the container holder; (iii) arranging a chamber such that it tightly couples to the container holder to form an encasing of a second aperture being the other one of the open end of the container or the outlet of the container when the first aperture is received by the container holder; and (iv) applying a test cycle according to a test protocol.
  • the method according to the invention and its preferred embodiments described below may efficiently implement the effects and benefits of the CCI testing system and its preferred embodiments described above.
  • the method according to the invention allows for an improved container closure testing and control in a comparably reliable, quick and reproducible manner.
  • the test protocol comprises a step of flushing the test gas through the chamber for a gassing duration.
  • the gassing duration preferably is in a range of about 5 seconds to about 10 minutes and, preferably, in a range of about 20 seconds to about 120 seconds.
  • the method preferably comprises a step of evaluating at least one test gas measurement of the test gas detector collected during flushing the test gas through the chamber.
  • the test protocol comprises a step of flushing a conditioning gas through the chamber for a conditioning duration.
  • the conditioning duration preferably is in a range of about 5 seconds to about 20 seconds and particularly is about 10 seconds.
  • the step of flushing the test gas through the chamber preferably is applied before the step of flushing the conditioning gas through the chamber.
  • the test protocol comprises a step of clearing a tight connection between the test gas detector and the first aperture for a clearing duration.
  • the clearing duration preferably is in a range of about 10 seconds to about 30 seconds and particularly is about 20 seconds.
  • the clearing step preferably comprises applying a subatmospheric pressure to the tight connection.
  • the step of flushing the test gas through the chamber preferably is applied after the step of clearing the chamber.
  • the method involves a CCI testing system as described above.
  • the control unit of the CCI testing system can be configured to apply the test cycle according to the test protocol.
  • FIG. 1 shows an embodiment of CCI testing system 1 according to the invention.
  • the CCI testing system 1 is designed to test closure integrity of a syringe 2 as container.
  • the syringe 2 has a barrel 22 with a hollow interior 223 an outlet 221 forming a first aperture of the syringe 2 and an open end 222 forming a second aperture of the syringe 2.
  • a stopper 21 is provided into the hollow interior 223 closing the hollow interior 223 and forming a dosage chamber between the stopper 21 and the outlet 221 .
  • the CCI testing system 1 comprises a Helium detector 11 as test gas detector, a syringe holder 13 as container holder, a chamber 14, a flow regulator 15 equipped with a flow meter as flow regulation unit, a valve arrangement 16, two gas supplies 17 and a control unit 18.
  • the chamber 14 is coupled to the syringe holder 13 and encases the complete syringe 2 extending out of the seat 131 of the syringe holder 13, when the outlet 221 is received by seat 131. It has an exhaust outlet 141 at a bottom to allow gas to exit the chamber 14. Further, it has an inlet 142 which is connected to the flow regulator 15 via a pipe. The flow regulator 15 is in fluid connection with the valve arrangement 16 via another pipe.
  • the gas supplies 17 comprise a Helium supply 171 having a pressure tank filled with Helium as test gas and a Nitrogen supply 172 having a pressure tank filled with Nitrogen as conditioning gas.
  • the valve arrangement 16 has a first valve 161 associated to the Helium supply 171 and a second valve 162 associated to the Nitrogen supply 172. By means of the first and second valves 161 , 162 the valve arrangement 16 is configured to selectively open and close the Helium supply 171 and the Nitrogen supply 172.
  • the gas supplies 17 are coupled to the inlet 142 of the chamber 14 via the valve arrangement 16 and the flow regulator 15.
  • the computer of the control unit 18 runs a dedicated software to implement a test protocol for applying a test cycle. More specifically, the test protocol includes a sequence of steps to be performed in the test cycle including the following.
  • control unit 18 activates the Helium detector 11 to apply a vacuum to the container holder 13 for 20 seconds.
  • the connection pipe between the Helium detector 11 and the container holder 13 as well as the channel 132 of the container holder 13 form a tight connection between the Helium detector 11 and the syringe seat 131 and, thus, the outlet 221 of the syringe 2.
  • the container holder 13 is configured to effect the vacuum of the Helium detector 11 to the outlet 221 of the syringe 2.
  • the control unit 18 applies a gassing step for a gassing duration of 30 seconds. Therefore, the control unit 18 adapts the valve arrangement 16 to open the first valve 161 , thereby activating the Helium supply 171 , and to close the second valve 162, thereby deactivating the Nitrogen supply 172. Since the Helium is held at an overpressure in the pressure tank of the Helium supply 171 , which is configured to release the Helium at about 1.5 bar, the control unit 18 can adjust a flow rate and pressure provided by adjusting the flow regulator 15. The flow rate further is monitored by the flow meter of the flow regulator 15 such that the control unit 18 accurately sets a predefined flow rate by opening the first valve 161 and controlling the flow regulator 15. The Helium passing the first valve 161 flows into the chamber 14 via the inlet 142 and exits the chamber 14 vis the exhaust outlet 141. Like this, the chamber 14 is flushed by Helium.
  • the open end 222 of the syringe 2 is exposed to a Helium flow.
  • a pressure difference between the interior 223 of the syringe and the inside of the chamber 14 can precisely and constantly be set.
  • the Helium detector 11 measures for Helium exiting the outlet 221 of the syringe 2.
  • the Helium measurements collected by the Helium detector 11 are transferred to the control unit 18 which evaluates the Helium measurements to establish an assessment of the closure integrity of the syringe 2 being closed by the stopper 21 .
  • the control unit 18 applies a conditioning step for a conditioning duration of 10 seconds.
  • the control unit 18 adapts the valve arrangement 16 to close the first valve 161 , thereby deactivating the Helium supply 171 , and to open the second valve 162, thereby activating the Nitrogen supply 172. Since the Nitrogen is held at an overpressure in the pressure tank of the Nitrogen supply 172 which is configured to release the Nitrogen at about 6 bar, the Nitrogen supply 172 provides Nitrogen, wherein a flow of Nitrogen is adjusted by the control unit 18 based on data obtained from the flow regulator 15. The Nitrogen flushes the chamber 14 by entering its inlet 142 and exiting its exhaust outlet 141 .
  • the disclosure also covers all further features shown in the Fig. individually although they may not have been described in the afore or following description. Also, single alternatives of the embodiments described in the figures and the description and single alternatives of features thereof can be disclaimed from the subject matter of the invention or from disclosed subject matter.
  • the disclosure comprises subject matter consisting of the features defined in the claims or the exemplary embodiments as well as subject matter comprising said features.
  • the present disclosure covers intermediate generalisations of features or groups of features of the embodiments described and shown in the figures. I.e., specific features or groups of features as disclosed in the figures and the associated sections of the description may be combined with the more general embodiments of the invention as disclosed in connection with the description of the invention.

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  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Examining Or Testing Airtightness (AREA)

Abstract

Un système de test CCI (1) pour tester l'intégrité de fermeture d'un récipient (2) avec un intérieur creux (223), une sortie (221), une extrémité ouverte (222) et un bouchon (21) agencé pour fermer l'intérieur creux (223), comprend un support de récipient (13), une alimentation en gaz de test (171), un détecteur de gaz de test (11) et une chambre (14). Le support de récipient (13) est conçu pour recevoir étroitement une première ouverture qui est l'une de l'extrémité ouverte (222) du récipient (2) ou de la sortie (221) du récipient (2). L'alimentation en gaz d'essai (171) comprend un gaz d'essai. Le détecteur de gaz de test (11) est étroitement couplé au support de récipient (13) et configuré pour détecter un gaz de test sortant de la première ouverture lorsqu'il est reçu par le support de récipient (13). La chambre (14) est couplée au support de récipient (13) pour former une enveloppe d'une seconde ouverture qui est l'autre de l'extrémité ouverte (222) du récipient (2) ou de la sortie (221) du récipient (2) lorsque la première ouverture est reçue par le support de récipient (13). L'alimentation en gaz de test (171) est couplée à la chambre (14). Le détecteur de gaz d'essai (11) est conçu pour appliquer une pression sous-atmosphérique au support de récipient (13) et le support de récipient (13) est conçu pour effectuer la pression sous-atmosphérique vers la première ouverture. L'alimentation en gaz d'essai (171) est conçue pour fournir un gaz d'essai dans la chambre (14). La chambre (14) présente une sortie d'échappement (141). La chambre (14) est configurée pour exposer la seconde ouverture à un flux de gaz généré par l'alimentation en gaz de test (171) fournissant un gaz de test dans la chambre (14) et hors de la chambre (14) par l'intermédiaire de la sortie d'échappement (141), lorsque la première ouverture est reçue par le support de récipient (13).
PCT/EP2024/074154 2023-08-31 2024-08-29 Système et procédé de test d'intégrité de récipient Pending WO2025045990A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23194731.8 2023-08-31
EP23194731 2023-08-31

Publications (1)

Publication Number Publication Date
WO2025045990A1 true WO2025045990A1 (fr) 2025-03-06

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019053113A1 (fr) * 2017-09-14 2019-03-21 Lonza Ltd Dispositif et procédé pour test amélioré d'intégrité de fermeture
EP3757538A1 (fr) * 2019-06-26 2020-12-30 Sartorius Stedim Fmt Sas Systeme et procede pour detecter une perte possible d'integrite d'une poche flexible pour produit biopharmaceutique

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019053113A1 (fr) * 2017-09-14 2019-03-21 Lonza Ltd Dispositif et procédé pour test amélioré d'intégrité de fermeture
EP3757538A1 (fr) * 2019-06-26 2020-12-30 Sartorius Stedim Fmt Sas Systeme et procede pour detecter une perte possible d'integrite d'une poche flexible pour produit biopharmaceutique

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