IM3 Consulting Group

   Sterilization & Packaging

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Our staff has considerable expertise in all major sterilization methods including steam, ethylene oxide, vaporized hydrogen peroxide, peracetic acid, and novel methods including supercritical CO2 and NO2.  We evaluate sterilization methods for use with both reusable medical devices (hospital sterilization) and terminal sterilization of packaged single-use products (contract or industrial sterilization).  We also help sterilizer manufactures with process and cycle development, material compatibility, measurement of sterilant residuals, and microbiological methods.  We have excellent relationships with the leading third-party test laboratories, and can manage all aspects of your verification & validation protocols.  We also serve as a consultant to regulators for novel low-temperature sterilization methods.  Specific services include the following:

·     Material & Packaging Requirements for terminally-sterilized single-use medical devices per ISO 11607-1

·     Validation & Control of sterilization process per ISO 14937

·     Testing Sterility per ISO 11737-2

·     Selection and Validation of Chemical Indicators per ISO 11140-1 & FDA Guidance

·     Selection and Validation of Biological Indicators per ISO 11138 & FDA Guidance

·     Process Challenge Device and Test Pack Design and Testing

·     Development and Use of Resistometers per ISO 18472

·     Testing of new hospital sterilizers for FDA or CE Mark

·     Determination of Critical Process Parameters

·     Half-Cycle Test Protocols

·     Simulated Use and In Use testing

·     Biocompatibility testing of Materials

·     Qualification of ancillary products including sterilization containers, pouch, wraps and trays

·     Material & Functional Compatibility Testing

·     Survivor Curve analysis and D-Value Calculation via Direct Enumeration or Fraction Negative methods