Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluations, it features 64 new protocols on topics such as sterility assurance, media fill guidelines, and environmental control.Leak testing should be witnessed and signed off to signify approval. Acceptable leakage rates and leak testing procedures and reports should be based upon the SMACNA HVAC Duct Leakage Test Manual. 3.6.5 Insulation for HVAC ductwork anbsp;...
|Title||:||Validation Standard Operating Procedures|
|Author||:||Syed Imtiaz Haider|
|Publisher||:||CRC Press - 2006-05-30|