Sterilization Management

Sterilization plays a critical role in the medical device development process. A proper sterilization validation is required to meet regulatory requirements. Our engineering team will work with you to develop and maintain sterilization processes that bring your device to market in the most effective and efficient way possible.

The optimal sterilization process for a given device is determined by materials, shelf life, quality, and application requirements of the device. The following sterilization processes are commonly used throughout the medical device industry:

  • Gamma sterilization
  • ETO sterilization
  • E-Beam sterilization

The Biomerics engineering team will work with you to develop a product validation plan that will be compliant to regulatory requirements based on the device classification and specifications. Our engineering and validation services include:

  • Sterilization Validation
  • Packaging Validation
  • Biocompatibility
  • Shipping Validation
  • Environmental Process Controls
  • Stability (Shelf Life) Validation
  • Sterilization Audit & Release Testing Plan

All test methodologies and procedures are executed in strict accordance with ISO, USP, AAMI and/or specific customer supplied requirements.

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