GAMMA AND TEMPERATURE HARDENED PHARMACEUTICAL DEVICES

• US 20100017159A1
• Filed: 07/14/2009
• Published: 01/21/2010
• Est. Priority Date: 07/16/2008
• Status: Active Grant

• Current Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Original Assignee: EMD Millipore Corporation (Merck & Co., Inc.)
• Inventors: Burke, Aaron
• Granted Patent: US 8,753,569 B2
• Time in Patent Office: Days
• US Class Current: 702/81
• CPC Class Codes: A61L 2/081 Gamma radiation
• CPC Class Codes: A61L 2/087 Particle radiation, e.g. electron-beam, alpha or beta radiation
• CPC Class Codes: A61L 2202/24 Medical instruments, e.g. endoscopes, catheters, sharps

Abstract

A system and method for implementing embedded electronics in environments where radiation or extreme temperatures are used is disclosed. Embedded electronics are affixed to various components of a pharmaceutical system, thereby enabling the customer to download pertinent information about the component, such as lot number, date of manufacturer, test parameters, etc. Additionally, these electronics allow an array of functions and features to be implemented, such as integrity tests and diagnostics. The electronics in the pharmaceutical components utilize a technology that is not as susceptible to radiation and extreme temperatures as traditional electronics.

Claims

1. A method of creating a sterile component, having embedded electronics, comprising:

manufacturing an electronic device using Silicon on Insulator (SOI) technology;

affixing said electronic device to said component; and

sterilizing said component by subjecting said component to gamma or beta radiation.

2. The method of claim 1, wherein said component is selected from the group consisting of filters, bags, tubes and process instruments.

3. The method of claim 1, wherein said electronic device comprises wireless communication means.

4. The method of claim 3, wherein said means comprises RFID.

5. The method of claim 3, wherein said means comprises the communication protocol described in IEEE 802.15.4.

6. The method of claim 3, wherein said means comprises the communication protocol described in IEEE 802.15.1.

7. The method of claim 1, wherein said electronic device is a sensor adapted to convert a physical characteristic to an electric signal, selected from the group consisting of fluid condition sensors, including pressure sensors, temperature sensors, and flow rate sensors, and fluid component sensors, including chemical sensors and concentration sensors.

8. The method of claim 7, wherein said sensor comprises a sensor head, and said sensor head is manufactured using SOI technology.

9. The method of claim 7, wherein said sensor comprises a signal processing unit, and said signal processing unit is manufactured using SOI technology.

10. The method of claim 1, wherein said radiation is transmitted substantially along one direction, and said electronic device is oriented so as not to maximize its surface area exposed to said radiation.

11. The method of claim 1, further comprising the step of reconditioning said electronic device after exposure to said radiation.

12. The method of claim 11, further comprising attaching a heater near said electronic device and wherein said reconditioning comprises activating said heater subsequent to said exposure to said radiation.

13. The method of claim 1 further comprising the step of reconditioning said electronic device after exposure to said radiation wherein the step of reconditioning said electronic device is selected from the group consisting of keeping the device shut off for a preset period of time and heating the electronic device.

14. A method of creating a sterile component for pharmaceutical or medical use having embedded electronics, comprising:

manufacturing an electronic device using Silicon on Insulator (SOI) technology;

affixing said electronic device to said component; and

sterilizing said component by subjecting said component to high temperature steam sterilization.

15. The method of claim 14, wherein said component is selected from the group consisting of filters, bags, tubes and process instruments.

16. The method of claim 14, wherein said electronic device comprises wireless communication means.

17. The method of claim 14, wherein said means comprises RFID.

18. The method of claim 14, wherein said means comprises the communication protocol described in IEEE 802.15.4.

19. The method of claim 14, wherein said means comprises the communication protocol described in IEEE 802.15.1.

20. The method of claim 14, wherein said electronic device is a sensor adapted to convert a physical characteristic to an electric signal, selected from the group consisting of fluid condition sensors, including pressure sensors, temperature sensors, and flow rate sensors, and fluid component sensors, including chemical sensors and concentration sensors.

21. The method of claim 20, wherein said sensor comprises a sensor head, and said sensor head is manufactured using SOI technology.

22. The method of claim 20, wherein said sensor comprises a signal processing unit, and said signal processing unit is manufactured using SOI technology.

23. The method of verifying the temperature profile of a pharmaceutical or medical product as it is being brought to its desired storage temperature, comprising:

a. Affixing a temperature sensor to a container or carrier for said product, wherein said temperature sensor is constructed from electronic devices manufactured using SOI technology;

b. Placing said product into a temperature chamber adapted to bring said product to said desired storage temperature;

c. Using said temperature sensor to record a plurality of temperature measurements as said product is brought to said desired temperature; and

d. Comparing said plurality of temperature measurements to an acceptable temperature profile.

24. The method of claim 23, wherein said temperature sensor records temperatures at fixed intervals.

25. The method of claim 23, wherein said temperature sensor transmits said plurality of temperature measurements to an external device before said comparison is performed.

26. The method of claim 23, wherein said measurements are transmitted wirelessly.

27. The method of claim 23 further comprising the steps of

(e) bringing the product back to a desired use temperature;

(f) Using said temperature sensor to record a plurality of temperature measurements as said product is brought back to its desired use temperature; and

(g) Comparing said plurality of temperature measurements to an acceptable temperature profile.