by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To define the procedure for calibration of the Slit-to-Agar Air Sampler used for environmental monitoring to ensure accurate measurement of microbial air contamination. 2. Scope This SOP applies to all STA air samplers used in microbiology or cleanroom...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To define the procedure for proper handling, storage, usage, and disposal of biological indicators (BIs) used to monitor and validate sterilization processes (steam, dry heat, ethylene oxide, hydrogen peroxide, etc.). 2.0 Scope This SOP applies to all...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the procedure for performing the Bowie-Dick test to assess steam penetration and air removal efficiency in steam sterilizers (autoclaves). 2.0 Scope This SOP applies to all steam sterilizers (autoclaves) used in pharmaceutical manufacturing,...
by Dr. Yashashwini Reddy | Aug 28, 2025
1. Purpose To define a standardized procedure to evaluate and verify the antimicrobial effectiveness of disinfectants and sporicidal agents used for routine cleaning and disinfection of classified and non-classified areas, equipment surfaces, and utilities in the...
by Dr. Yashashwini Reddy | Aug 27, 2025
Maintenance of Aseptic Conditions in Pharmaceutical Sterile Areas 1. Introduction Sterile areas in pharmaceutical manufacturing (e.g., aseptic filling, compounding, cleanrooms, isolators) require strict control to prevent contamination. Maintaining aseptic conditions...
