Single-use container, system and method for the prevention of over-pressurization

Patent metadata

Field	Value
Publication number	US-2016298810-A1
Application number	US-201514680370-A
Country	US
Kind code	A1
Filing date	Apr 7, 2015
Priority date	Apr 7, 2015
Publication date	Oct 13, 2016
Grant date	—

Abstract

A single-use container for the prevention of over-pressurization is provided. The single-use container has an enclosure for a fluid and an over-pressurization relief device fluidly connected to the enclosure. The over-pressurization relief device is configured to relieve pressure from the enclosure when a pressure of the fluid within the enclosure exceeds a specified relief pressure. The specified relief pressure is set to be lower than the burst pressure of the enclosure. The over-pressurization relief device is connectable to a controlled pathway for relieving the fluid from the enclosure in a controlled manner.

First claim

What is claimed is:

1 . A single-use container ( 10 ) comprising an enclosure ( 100 ) for a fluid and an over-pressurization relief device ( 120 ) fluidly connected to the enclosure ( 100 ),
wherein the over-pressurization relief device ( 120 ) is configured to relieve pressure from the enclosure ( 100 ) when a pressure of the fluid within the enclosure ( 100 ) exceeds a specified relief pressure, wherein the specified relief pressure is set to be lower than the burst pressure of the enclosure ( 100 ), and wherein the over-pressurization relief device ( 120 ) is connectable to a controlled pathway for relieving the fluid from the enclosure ( 100 ) in a controlled manner.

2 . The single-use container ( 10 ) of claim 1 , wherein the single-use container ( 10 ) is a sterilizable plastic disposable container that is adapted to contain at least one fluid.

3 . The single-use container ( 10 ) of claim 1 , wherein the over-pressurization relief device ( 120 ) is integrated into the enclosure ( 100 ).

4 . The single-use container ( 10 ) of claim 3 , wherein the over-pressurization relief device ( 120 ) is configured such that it can be sterilized utilizing a validated method, preferably by at least one of gamma irradiation, autoclaving, steam sterilization and chemical sterilants.

5 . The single-use container ( 10 ) of claim 1 , wherein the over-pressurization relief device ( 120 ) is located at an external container ( 118 ) that is aseptically connected ( 112 ) to the enclosure ( 100 ).

6 . The single-use container ( 10 ) of claim 5 , wherein the over-pressurization relief device ( 120 ) is configured such that it can be sterilized utilizing a validated method, preferably by at least one of gamma irradiation, autoclaving, steam sterilization and chemical sterilants.

7 . The single-use container ( 10 ) of claim 1 , wherein the over-pressurization relief device ( 120 ) comprises at least one film layer ( 202 ) configured to break when being exposed to a breakage pressure corresponding to the specified relief pressure.

8 . The single-use container ( 10 ) of claim 7 , wherein the film structure of the at least one film layer ( 202 ) is weakened in at least one position to set the breakage pressure.

9 . The single-use container ( 10 ) of claim 8 , wherein the film structure is weakened by at least one of stretching, perforation, chemical processing, and physical processing.

10 . The single-use container ( 10 ) of claim 7 , further comprising at least one sensor configured to indicate when the at least one film layer ( 202 ) has been breached because exposed to the breakage pressure.

11 . The single-use container ( 10 ) of claim 7 , wherein the at least one film layer ( 202 ) comprises an electrical wire ( 228 ) that carries an electric current, the electrical wire ( 228 ) being configured to break and to trigger an alarm when the at least one film layer ( 202 ) is exposed to the breakage pressure.

12 . The single-use container ( 10 ) of claim 7 , further comprising at least one of a laser and/or a beam of light adjacent the at least one film layer ( 202 ), wherein the at least one of a laser and/or a beam of light is configured to be deflected and to trigger an alarm when the at least one film layer ( 202 ) is exposed to the breakage pressure.

13 . The single-use container ( 10 ) of claim 7 , wherein the over-pressurization relief device ( 120 ) comprises multiple film layers and/or membrane filters having different pressure relief ratings which can be selected and deployed into a flow path of the enclosure ( 100 ) to adjust the specified relief pressure.

14 . The single-use container ( 10 ) of claim 1 , wherein the over-pressurization relief device ( 120 ) comprises at least one membrane filter ( 242 ) configured to have a bubble point pressure corresponding to the specified relief pressure.

15 . The single-use container ( 10 ) of claim 14 , further comprising a reservoir of wetting fluid.

16 . The single-use container ( 10 ) of claim 15 , wherein the single-use container contains at least one of the following: a valve, a backflow prevention device, a film layer to prevent the wetting fluid in the fluid reservoir from entering into the enclosure ( 100 ).

17 . The single-use container ( 10 ) of claim 14 , further comprising at least one of a chiller and/or a coating on the membrane filter ( 242 ) configured to facilitate condensation onto the at least one membrane filter ( 242 ).

18 . The single-use container ( 10 ) of claim 14 , further comprising at least one sensor configured to indicate when the at least one membrane filter ( 242 ) has achieved bulk flow due to being exposed to the bubble point pressure.

19 . The single-use container ( 10 ) of claim 14 , wherein the over-pressurization relief device ( 120 ) comprises multiple film layers and/or membrane filters having different pressure relief ratings which can be selected and deployed into a flow path of the enclosure ( 100 ) to adjust the specified relief pressure.

20 . The single-use container ( 10 ) of claim 1 , wherein the over-pressurization relief device ( 120 ) comprises at least one film layer configured to break at a breakage pressure corresponding to the specified relief pressure and at least one membrane filter configured to have a bubble point pressure corresponding to the specified relief pressure.

21 . The single-use container ( 10 ) of claim 1 , wherein the over-pressurization relief device ( 120 ) comprises at least one of:
at least one internal film layer configured to break at a breakage pressure corresponding to the specified relief pressure, at least one membrane filter configured to have a bubble point pressure corresponding to the specified relief pressure, and at least one external film layer configured to break at a breakage pressure enclosed within a holder.

22 . The single-use container of claim 1 , wherein the over-pressurization relief device ( 120 ) further comprises a pressure relief valve.

23 . A system for the prevention of over-pressurization in a single-use container ( 10 ), the system comprising:
the single-use container ( 10 ) of claim 1 , and a controlled pathway ( 500 ) connected to the over-pressurization relief device ( 120 ) of the single-use container ( 10 ).

24 . The system of claim 23 , wherein the controlled pathway ( 500 ) connects to at least one of an external pressure relief device, an external filter ( 144 ; 180 ), and a drain ( 188 ).

25 . The system of claim 23 , wherein the controlled pathway ( 500 ) comprises at least one sterilizing-grade filter.

26 . A method to prevent over-pressurization in a single-use container ( 10 ), the method comprising:
connecting an enclosure ( 100 ) for a fluid with an over-pressurization relief device ( 120 ) for relieving pressure from the enclosure ( 100 ) when a pressure of the fluid within the enclosure ( 100 ) exceeds a specified relief pressure, wherein the specified relief pressure is set to be lower than the burst pressure of the enclosure ( 100 ), and connecting a controlled pathway ( 500 ) to the over-pressurization relief device ( 120 ) for relieving the fluid from the enclosure ( 100 ) in a controlled manner.

Assignees

• Sartorius Stedim Biotech Gmbh

Inventors

• Maggiore Frank

Classifications

• F17C2260/021

  Avoiding over pressurising · CPC title

• F17C13/06 Primary

  Closures, e.g. cap, breakable member ({for autoclaves B01J3/03}; closures for {large} containers in general B65D {B65D90/54}; {for pressure vessels in general F16J13/00}) · CPC title

• F17C2205/0341

  Filters · CPC title

• C12M41/40

  of pressure · CPC title

• C12M23/14 Primary

  Bags · CPC title