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 | May 3, 2025
In a sterile facility, especially in industries like pharmaceuticals, biotechnology, or medical device manufacturing, maintaining a controlled environment is crucial for ensuring product safety and preventing contamination. One key component in maintaining sterility...
