Inline sensor arrangement and method for commissioning same

Patent metadata

Field	Value
Publication number	US-10705044-B2
Application number	US-201615386015-A
Country	US
Kind code	B2
Filing date	Dec 21, 2016
Priority date	Dec 21, 2015
Publication date	Jul 7, 2020
Grant date	Jul 7, 2020

Abstract

The present disclosure includes an inline sensor arrangement and a method for bringing an inline sensor arrangement into service, where the inline sensor arrangement includes a sensor embodied to produce and to output a measurement signal correlated with the measured variable, and where the sensor has at least one sterile sensor element for contact with the measured medium and at least one housing, which surrounds the sensor element and encloses the sensor element in a chamber sealed from an environment of the housing. The method includes performing a heat sterilization of at least one part of the inline sensor arrangement comprising a housing exterior of the housing, opening the housing after terminating the heat sterilization, and bringing the sensor element into contact with the measured medium.

First claim

The invention claimed is:

1. A method for bringing an inline sensor arrangement into service for registering measured values of a measured variable representing an analyte content of a measured medium, the method comprising:
providing an inline sensor arrangement including a sensor structured to produce and to output a measurement signal correlated with a measured variable representing an analyte content of a measured medium, wherein the sensor has at least one sterile sensor element configured to contact the measured medium and a housing that surrounds and encloses the sensor element in a chamber sealed from an environment of the housing;
performing a heat sterilization of at least one part of the inline sensor arrangement including a housing exterior of the housing;
irreversibly opening the housing to an interior of the container in a sterilized region of the housing exterior of the housing after terminating the heat sterilization; and
bringing the sensor element into contact with the measured medium.

2. The method of claim 1 , wherein the opening of the housing and the bringing of the sensor element into contact with the measured medium occurs aseptically.

3. The method of claim 1 , the method further comprising sealedly integrating the inline sensor arrangement into a wall of a process container before the performing of the heat sterilization, wherein the heat sterilization of the inline sensor arrangement is performed simultaneously with a heat sterilization of the process container, and wherein the housing is opened to the process container after termination of the heat sterilization.

4. The method of claim 3 , wherein the process container has a container connection that surrounds a connector space communicating with the process container, and the inline sensor arrangement includes a process connection complementary to the container connection, the method further comprising:
connecting the container connection with the process connection before the performing of the heat sterilization, wherein the process connection is connected with the housing of the inline sensor arrangement such that the sensor element is arranged on a side outside of the connection space and facing away from the process container when the process connection and the connection of the process container are connected with one another.

5. The method of claim 1 , wherein the performing of the heat sterilization of the inline sensor arrangement occurs in an autoclave.

6. The method of claim 1 , the method further comprising registering the humidity within the housing as a function of time at least during the performing of the heat sterilization, wherein the inline sensor arrangement includes at least one humidity sensor for registering the humidity within the housing.

7. The method of claim 1 , wherein the housing includes a wall formed from one or more housing components sealedly enclosing the chamber and forming a barrier against the diffusion of steam into the chamber, and wherein the wall has an average water vapor permeability of less than 420 g/m 2 ·d, at a temperature of 110° C., a pressure difference between the chamber and the environment of the housing wall of less than 5 bar, and a difference between the relative humidities in the chamber and the environment of the wall of greater than 67%.

8. The method of claim 7 , wherein the wall has an average water vapor permeability of less than 125 g/m 2 ·d.

9. The method of claim 7 , wherein the wall has an average water vapor permeability of less than 15 g/m 2 ·d.

10. The method of claim 7 , wherein the wall has an average water vapor permeability of less than 6 g/m 2 ·d.

11. The method of claim 1 , wherein the at least one sensor element includes at least one biological detection element for the analyte.

12. The method of claim 11 , wherein the at least one biological detection element for the analyte is an enzyme that is lyophilizable while maintaining at least 10% of its activity.

13. The method of claim 1 , wherein the at least one sensor element is an enzyme based glucose sensor including glucose oxidase.

14. The method of claim 1 , wherein the at least one sensor element is thermally decoupled from the environment of a housing exterior of the housing at least during the performing of the heat sterilization.

15. The method of claim 1 , wherein the inline sensor arrangement includes at least one temperature sensor, the method further comprising:
monitoring a temperature of the at least one sensor element during the heat sterilization using the at least one temperature sensor.

16. The method of claim 1 , wherein the chamber contains silica gel or zeolite.

17. The method of claim 1 , wherein a relative humidity within the housing does not exceed 23%.

18. The method of claim 1 , wherein a relative humidity within the housing does not exceed 3%.

19. The method of claim 1 , wherein a relative humidity within the housing does not exceed 1%.

20. A method for bringing an inline sensor arrangement into service for registering measured values of a measured variable representing an analyte content of a measured medium, the method comprising:
providing an inline sensor arrangement including a sensor structured to produce and to output a measurement signal correlated with a measured variable representing an analyte content of a measured medium, wherein the sensor has at least one sterile sensor element configured to contact the measured medium and a housing that surrounds and encloses the sensor element in a chamber sealed from an environment of the housing;
performing a heat sterilization of at least one part of the inline sensor arrangement including a housing exterior of the housing;
before performing the heat sterilization, cooling the inline sensor arrangement to less than 8° C.;
opening the housing after terminating the heat sterilization; and
bringing the sensor element into contact with the measured medium.

21. The method of claim 20 , the inline sensor arrangement is cooled to less than −13° C.

22. The method of claim 20 , the inline sensor arrangement is cooled to less than −20° C.

Assignees

• Endress Hauser Conducta Gmbh Co Kg

Inventors

• Hanko Michael
• Eubisch Angela
• Heymann Anne

Classifications

• A61L2103/23

  Containers other than laboratory or medical, e.g. bottles or mail · CPC title

• G01N27/283

  Means for supporting or introducing electrochemical probes · CPC title

• C12Q1/006

  for glucose · CPC title

• A61L2/04

  Heat (radiation A61L2/08) · CPC title

• G01N33/54366

  Apparatus specially adapted for solid-phase testing · CPC title