Contract Cleanroom Assembly and Packaging
An ISO and FDA Registered Facility: ISO 13485:2003 | FDA Registered 2032092
Validation of processes used to sterilize medical device equipment are the most critical validation activities undertaken. Validation of the sterilization process is required to provide evidence of compliance to regulatory bodies. The objective of Validation is to determine that the sterilization process will consistently achieve sterility and that it won't have an undesirable effect on the device or its packaging.
SpecialTeam provides contracted certified sterilization validation services that meet current requirements for each form of sterilization.
We can provide turnkey product validation with all necessary documentation, product sample submissions and quarterly validation requirements.
Per FDA guidelines, a written plan is developed. The plan states how validation will be conducted, including test parameters, product characteristics, production equipment, and decision points on what constitutes acceptable test results. As an ISO Certified (ISO 13485:2003) and FDA Registered (2032092) facility, we ensure that the validation process is documented and that the documentation is properly maintained.