Sterilization validation

Sterilization validation and requalification are critical activities to demonstrate that a medical device can be consistently sterilized without compromising product safety, performance or packaging integrity.

SteriLandBio supports medical device manufacturers in the planning, execution, review and remediation of sterilization validation and requalification activities across all sterilization methods, including ethylene oxide, radiation, steam, dry heat, etc.

Our support may include the definition of validation or requalification strategy, product family and worst-case rationale, protocol and report preparation or review, bioburden and microbiological assessment, dose or cycle justification, deviation assessment, product adoption evaluations, routine monitoring strategy and alignment with applicable standards and regulatory expectations.

We help companies build sterilization validation and requalification packages that are technically justified, traceable and suitable for certification, audit review and routine process control.