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
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...
by Dr. Yashashwini Reddy | Aug 27, 2025
Validation of Clean Room Pass Boxes 1. Introduction A pass box is an enclosed space with doors on both sides, installed between two areas of different cleanliness grades.It allows the transfer of materials with minimum air turbulence and controlled contamination...
by Dr. Yashashwini Reddy | Aug 18, 2025
Contamination Control Strategies for Manufacturing Area In pharmaceutical manufacturing, contamination control is critical to ensure product quality, patient safety, and regulatory compliance. Contamination can occur in the form of particulate, microbial, chemical, or...
