A clean room facility is one which has a defined environmental control of particulate and microbial contamination and is constructed, maintained, and used in such a way as to minimize the introduction generation and retention of contaminants.
GMD Disposables has an ultra-modern Clean Room facility the entire manufacturing area is designed to meet Class 10,000 cleanliness standard of US FED 209E equivalent to ISO Class 7.
All process areas have terminal High Efficiency Particulate (HEPA) Filters with an efficiency of 99.97% down to 0.3 micron. Raw material movement into the clean room facility is through well-designed air locks and dynamic pass boxes.
This provides an environment which protects from external contamination and reduces the bio-burden on the product prior to sterilization, thus ensuring low amounts of endotoxins post-sterilization.