Using contract sterilization organizations is an extremely popular method amongst the medical, pharmaceutical and food industries. Outsourcing of the sterilization validation process is cost-effective, but the organization must be able to validate their entire process to be able to prove the standards required.
Drug products and equipment require validation of the processes used for sterilization. Sterilization validation methods will always reach high levels of sterility without affecting the packaging or the device.
The FDA Enforces the Rules
The Food and Drug Administration sets the minimum standards required for all sterilization validation. This applies to medical devices and finished pharmaceuticals.
The validation process used will always include the purpose and objectives of the sterilization system. It will list the specific characteristics of the production equipment and detail all the tests that will be performed.
Specifically, the criteria for acceptance for meeting the quality standards must be clear from the data that is collected. The process will identify how and when approvals are given and provide the effective date and any documentation that is required to support the requirements.
The reports will provide an ongoing assessment of all the equipment used. Any deviations from standard practices must be validated to ensure that the criteria for acceptance have been met in all circumstances.
What Will the Results Look Like?
The process testing results will be produced in a manner that is expected.
Different sterilization validation processes will be used, depending upon the sterilization method used. Therefore, different detailed reports and methods will be required for ethylene oxide validation, radiation validation, and steam validation.
Using a high-quality contract sterilization organization is important to be able to ensure that all the processes are carried out to a minimum standard as required by law. An experienced contract sterilization company will meet and surpass all the requirements necessary and can provide expert validation for all of their processes and methods used.
