by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) Here is a complete Standard Operating Procedure (SOP) for the Sanitization of FFS (Form-Fill-Seal) Area, ensuring compliance with GMP standards and maintaining environmental control in sterile and non-sterile...
by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) 1.0 Objective To lay down the procedure for cleaning, sanitization, and verification activities required to resume aseptic area operations after any maintenance work, ensuring compliance with GMP and sterility...
by Dr. Yashashwini Reddy | May 12, 2025
Standard Operating Procedure (SOP) Here is a comprehensive SOP that covers the cleaning of Pressure Vessel, Peristaltic Pump, and Spraying Gun, typically used in pharmaceutical, biotech, or sterile manufacturing environments. 1. Objective To establish...
by Dr. Yashashwini Reddy | May 5, 2025
Blow Fill Seal (BFS) and Form Fill Seal (FFS) Technologies in Sterile Manufacturing In sterile manufacturing, maintaining product sterility is paramount, particularly for pharmaceuticals, biologics, and medical devices that require strict contamination control. Two...
by Dr. Yashashwini Reddy | May 3, 2025
Restricted Access Barrier System (RABS) in Pharmaceuticals – Detailed Explanation 1. Introduction A Restricted Access Barrier System (RABS) is a contamination control technology used in the pharmaceutical industry, particularly in aseptic processing environments. It...