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
1.0 Purpose To establish a procedure for performing finger dab (finger imprint) tests for monitoring personnel hygiene practices and aseptic conditions in classified areas. 2.0 Scope This SOP applies to all personnel working in aseptic and controlled areas (Grades A,...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To define the procedure for the preparation of disinfectant solutions used in pharmaceutical/biotechnology facilities for cleaning and sanitization purposes. 2.0 Scope This SOP applies to all personnel involved in the preparation, dilution, and labeling of...
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...
