Sterile packaging unit and method for producing same

Patent metadata

Field	Value
Publication number	US-11045566-B2
Application number	US-201615763609-A
Country	US
Kind code	B2
Filing date	Sep 22, 2016
Priority date	Sep 30, 2015
Publication date	Jun 29, 2021
Grant date	Jun 29, 2021

Abstract

A sterile packaging unit includes a disposable bioprocessing component ( 20 ) and a packaging ( 30 ). The disposable bioprocessing component ( 20 ) has a component wall that encloses a processing space and on which is secured a sensor system ( 40 ) with at least one sensor head (T, P, I, L, D) and with attached sensor electronics ( 42 ) that include a memory unit ( 44 ). The packaging ( 30 ) hermetically encloses the disposable bioprocessing component ( 20 ) and has a flexible packaging wall. The disposable bioprocessing component ( 20 ) and the packaging ( 30 ) are sterilized by being jointly irradiated with ionizing radiation. The sensor electronics ( 42 ) are connected electrically to a contact unit ( 34 ) extending through the packaging wall.

First claim

The invention claimed is:

1. A sterile packaging unit, comprising
a disposable bioprocessing component having a component wall defining and enclosing a processing space, a sensor mounted to the component wall, the sensor having at least one sensor head and with attached sensor electronics comprising a memory unit, a portion of the processing space being occupied by the sensor while leaving a remaining portion of the processing space unoccupied by the sensor, and
an outer packaging having a packaging wall, the disposable bioprocessing component being inserted in the packaging and the packaging wall being sealed to hermetically enclose the disposable bioprocessing component,
the outer packaging and the disposable bioprocessing component enclosed therein being in a sterilized state by being jointly irradiated with ionizing radiation,
wherein:
the sensor electronics are electrically connected to a contact unit extending through the packaging wall.

2. The packaging unit according to claim 1 ,
wherein:
the contact unit terminates in a pocket of the wrapper packaging wall that is accessible from outside of the wrapper packaging wall.

3. The packaging unit according to claim 1 ,
wherein:
the contact unit is electrically connected to an electrical energy storage.

4. The packaging unit according to claim 1 ,
wherein:
the sensor system comprises an electrically readable dosimeter.

5. The packaging unit according to claim 4 ,
wherein:
the sensor electronics comprise a control unit that is configured, after contacting the electrical energy storage, to read the dosimeter and write a read-out dose value into the memory unit.

6. The packaging unit according to claim 1 ,
wherein:
the sensor system comprises at least one environmental parameter sensor and the sensor electronics comprises a control unit that is configured, after contacting of the electrical energy storage, to periodically read the environmental parameter sensor electrical energy storage and to write read-out parameter values into the memory unit together with the corresponding reading time stamps.

7. The packaging unit according to claim 1 , further comprising:
a conductor extending through the component wall of the disposable bioprocessing component and connecting the sensor to the contact unit.

8. The packaging unit according to claim 1 , wherein the outer packaging comprises a flexible plastic bag defined at least in part by the packaging wall.

9. The packaging unit according to claim 1 , wherein the packaging wall is flexible.

Assignees

• Sartorius Stedim Biotech Gmbh

Inventors

• Leupold Marco
• Gao Wei
• Schlack Stefan
• Grimm Christian

Classifications

• A61L2202/181

  Flexible packaging means, e.g. permeable membranes, paper · CPC title

• A61L2/087 Primary

  Particle radiation, e.g. electron-beam, alpha or beta radiation · CPC title

• C12M37/00

  Means for sterilizing, maintaining sterile conditions or avoiding chemical or biological contamination (C12M23/38 takes precedence; filtration in general and filters per se B01D24/00-B01D41/00; autoclaves B01J3/04; treatment of microorganisms with electrical or wave energy C12N13/00) · CPC title

• A61L2/28

  Devices for testing the effectiveness or completeness of sterilisation or disinfection, e.g. indicators which change colour · CPC title

• C12M23/28

  disposable or single use · CPC title