Infrastructure

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.

We use a highly advanced 100% pure ethylene oxide gas sterilizer that delivers precise moisture levels for effective sterilization, and utilizes minimum quantity of ethylene oxide gas that was easy to recover at the end of the cycle. This procedure has taken into consideration the very special hygroscopic nature of synthetic absorbable sutures which has the tendency to bond effectively with ethylene oxide in the presence of moisture thus they degenerate and lose strength on storage, leading to serious implications for the patient and the surgeon.

Packaging is a very critical step especially when it comes to synthetic absorbable sutures which are moisture sensitive and tend to lose their tensile strength and absorption properties if not packed with a proper moisture and oxygen resistant barrier which is hermetically sealed.

GMD has developed, after in-depth study and months of research, a special device for the humidity sensitive suture were the aluminium packed suture will be vacuumed and nitrogen flushed to provide dual moisture barrier to help maintain the tensile strength of the suture material and give it a long shelf life.