by Dr. Yashashwini Reddy | Sep 1, 2025
🌡️ Different Types of Temperature Sensors 1. Thermocouples Principle: Seebeck effect (voltage generated at junction of two dissimilar metals). Range: –200 °C to +1800 °C (depending on type: J, K, T, R, S). Pros: Wide range, rugged, fast response. Cons: Lower accuracy...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To establish a standard procedure for monitoring non-viable airborne particulate matter in controlled manufacturing areas to ensure compliance with ISO 14644, EU GMP Annex 1, and regulatory requirements for sterile manufacturing. 2. Scope This SOP applies...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for monitoring microbiological contamination in controlled areas using the settle plate (passive air sampling) method. 2. Scope This SOP is applicable to all classified areas (Grade A/B/C/D) in manufacturing and microbiology...
by Dr. Yashashwini Reddy | Aug 29, 2025
1. Purpose To describe the procedure for performing microbiological integrity testing of sealed vials to ensure container closure integrity and sterility assurance. 2. Scope This SOP applies to all finished sterile product vials manufactured in the facility that...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the standard procedure for the safe and effective operation of the Fogster-ULV (Ultra-Low Volume) Fogger Machine for disinfection of classified and controlled areas in the facility. 2.0 Scope This SOP applies to all trained personnel...
