A clean room facility is one that has a defined environmental control of particulate and microbial contamination and is assembled, maintained and used in such a way as to minimize the introduction generation and retention of contaminants.
A.P.S. Surgicals has an ultra-modern Clean Room facility for manufacturing various kinds of Surgical Dressings and Medical Devices.
Some of the remarkable operational and constructional features of the our Clean
Room facility are:
- The whole manufacturing area is designed to meet Class 10,000 cleanliness standard of US FED 209E (i.e. not more than 10,000 particles of size 0.5 microns per cubic feet of air) equivalent to ISO Class 1. This provides an environment that protects from outside contamination
- The air handling systems are intended to ISO requirements (ISO 14644), thus supplying air of high quality with regard to particulates. The processing areas receive clean and filtered air with a minimum of 60 air changes per hour in the core process areas.
- All process areas have terminal High Efficiency Particulate (HEPA) Filters with an efficiency of 99.97% down to 0.3 micron.
- The air flow is unidirectional and in a laminar fashion across all workstations, lowering contamination risk.
- A differential pressure of 12 to 15 Pascals is preserved effectively between adjacent rooms to prevent ingress of particulates (viable and non-viable)
Temperature and relative humidity control is offered through an energy efficient air conditioning system and dehumidifiers, ensuring stability of environmental condition during manufacturing.
- The clean rooms are assembled with non-particle shedding modular panels made from powder coated GI sheets with polyurethane foam at its center, ensuring airtight clean rooms, better insulation and ease of maintenance. Epoxy flooring and covings at all corners give smooth surfaces and protect against generation and accumulation of dust. It’s offered to all employees entering the clean room facility, thus minimizing contamination in the clean room areas
- Raw material movement into the clean room facility is through well-designed air locks and dynamic pass boxes, thus minimizing the entrance of contaminants into the clean room facility
- All doors and windows are flushed with walls on both sides. The window and door frames are equipped with non-particle shedding gaskets to make them airtight.
- Door Interlocking System is supplied in all critical areas to avoid cross contamination and to prevent unauthorized man-material entranceAll the above features contribute significantly in reducing the bio-burden and particulates on the item before sterilization. This helps us create a risk-free, sterile product which can be used with confidence by the surgeons.