Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation prog

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by pr

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by pr

Appendix 1: Contract Radiation Sterilization Facilities in the United States -- Appendix 2: Method 1 Dose Verification -- Appendix 3: Method 1 Quarterly Dose Au

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edi