by Dr. Yashashwini Reddy | Sep 2, 2025
🔹 Buffer Area in Sterile Facility 1. Definition The Buffer Area (also called the cleanroom or critical area) is a Class 100 / ISO 5 / Grade A-B environment where aseptic processing, sterile filling, and direct product exposure operations are performed. It is...
by Dr. Yashashwini Reddy | Sep 2, 2025
📌 Restricted Access Barrier System (RABS) in Pharmaceuticals A Restricted Access Barrier System (RABS) is an advanced containment and protection technology used in pharmaceutical sterile manufacturing to reduce contamination risks. It provides a physical and...
by Dr. Yashashwini Reddy | Aug 27, 2025
Media Fill Test — Sterile API Manufacturing (Aseptic Process Simulation) 1. Objective To demonstrate that the aseptic API manufacturing process (including personnel, equipment, materials, and environment) can reliably produce a sterile product by simulating routine...
by Dr. Yashashwini Reddy | Aug 18, 2025
Types of Purified Water Systems in Pharmaceuticals Pharmaceutical industries require high-quality water for manufacturing, cleaning, and formulation. Different water systems are designed to meet specific pharmacopeial standards (USP, EP, IP, JP) depending on their...
by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) Here is a complete Standard Operating Procedure (SOP) for the Cleaning of Clean Area (Sterile Area) in pharmaceutical manufacturing, ensuring compliance with GMP and sterile environmental control requirements. 1.0...
