MANUFACTURING FACILITY- CLEAN ROOM CLASS

Highly specialized Cleanroom for manufacturing carrying specific requirements for sterility and regulatory accountability.

The entire manufacturing facility is designed to meet the Class 10,000 purity standard of ISO 14644 (i.e. not more than 3, 52,000 particles of size 0.5 microns per cubic meter of air) equivalent to ISO 14644 / Class 7. This eliminates the risk of exterior contamination.

The air-handling units are designed as per international standard ISO 14644, thus provides high-quality air with respect to particulate count. The handling zones are constructed to provide clean and purified air with at least 60 air changes per hour in the essential operation areas.

Cleanrooms provide total control over temperature, pressure, contamination and relative humidity control to ensure consistent cleanliness of products.

The maintenance of cleanroom in manufacturing through an energy-efficient air conditioning system and dehumidifiers, guaranteeing the stability of environmental conditions during production.

All practice areas have terminal High-Efficiency Particulate Air (HEPA) filters with an efficiency of 99.97% down to 0.3 microns.

Assembly Area/ Manufacturing Area – Clean Room Class 10,000 or ISO Class 7
Lab (Class 10,000 and Class 1,000) ISO Class 6 and ISO Class 7
A differential pressure as per ISO 14644 is sustained successfully amid adjoining rooms to restrict the entry of particulates (viable and non-viable).

The cleanrooms have been constructed with non-particle shedding modular panels (PUF panels) built of powder-coated GI sheets with polyurethane foam at its core, guaranteeing airtight clean rooms, improved protection and ease of maintenance.

Epoxy flooring and covings at each angle provide ultra-fine surfaces and avoid production and accrual of dirt. It also avoids settling and safeguard of microbes in intervals. Non-shedding / lint-free cleanroom wear is obligatory for all personnel entering the cleanroom set-up area, thus diminishes the contamination.

Moulded components enter the cleanroom through well-designed airlocks and dynamic pass boxes, which precludes the entry of contaminants.

Moulding area is also maintained to Clean Room Class 10,000 or ISO Class 7 whereas the permissible limit is Clean Room Class 100,000.

Door Interlocking System is provided in all major areas to restrict the entry of contaminants into clean rooms set up areas.

“All the above salient features provide us with the confidence to assure the quality of our products.”