Temperature hardened pharmaceutical devices

• US 8,753,569 B2
• Filed: 07/14/2009
• Issued: 06/17/2014
• 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
• Primary Examiner(s): Griffin, Walter D.
• Assistant Examiner(s): Vandeusen, Christopher
• Application Number:
  US12/502,259
• Publication Number:
  US 20100017159A1
• Time in Patent Office: 1,799 Days
• Field of Search: 422/28
• US Class Current: 422/28
• 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 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, wherein said electronic device is a sensor, comprising a sensor head adapted to convert a physical characteristic to an electric signal and a sensor body, wherein said sensor is 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, and wherein said sensor comprises a storage device proximate said sensor head and configured to store calibration data associated with said sensor head, whereby said sensor head and said storage device are manufactured using SOI technology.

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 a communication protocol in accordance with IEEE 802.15.4.

6. The method of claim 3, wherein said means comprises a communication protocol in accordance with IEEE 802.15.1.

7. The method of claim 1, wherein said sensor body is manufactured using SOI technology.

8. The method of claim 1, wherein said sensor body comprises a signal processing unit, and said signal processing unit is manufactured using SOI technology.