Optimizing sterilization management

Our engineering team will work with you to develop and manage the optimal sterilization process for your device, including gamma, EtO, and e-beam sterilization. We can also develop a product validation plan that complies with regulatory requirements. We have our own validated EtO sterilization cycle with weekly runs. Many new products can be qualified without a full validation. All test methodologies and procedures comply with ISO, USP, AAMI and/or customer-supplied requirements. Our services include:

• Sterilization validation
• Bioburden
• Environmental process controls
• Sterilization audit & release testing plan