Gamma and temperature hardened pharmaceutical devices

• US 8,798,954 B2
• Filed: 03/08/2012
• Issued: 08/05/2014
• 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): Bui, Bryan
• Application Number:
  US13/414,886
• Publication Number:
  US 20120163411A1
• Time in Patent Office: 880 Days
• Field of Search: 702/130
• US Class Current: 702/130
• 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 verifying a temperature profile of a pharmaceutical or medical product as said product is being brought to a 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. bringing 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 storage temperature; and

d. comparing said plurality of temperature measurements to an acceptable temperature profile to insure a proper temperature profile was followed.

2. The method of claim 1, wherein said temperature sensor records temperatures at fixed intervals.

3. The method of claim 1, wherein said temperature sensor transmits said plurality of temperature measurements to an external device before said comparison is performed.

4. The method of claim 1, wherein said measurements are transmitted wirelessly.

5. The method of claim 1, further comprising the steps of

(e) bringing said product to a desired use temperature;

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

(g) comparing said plurality of temperature measurements to an acceptable temperature profile to insure a proper temperature profile was followed.

6. The method of claim 1, wherein said desired storage temperature is less than −

55°

C.