Clean Rooms - creating the right environment

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.

Lotus Surgicals has an ultra-modern Clean Room facility for manufacturing various medical devices. The infrastructure complies with the specifications, testing and validation norms of International Regulatory Agencies, such as ISO, WHO, USFDA and EU.

Some of the impressive operational and constructional features of the Lotus Clean Room facility are:

• The entire 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 7. This provides an environment which protects from external contamination
• The air handling systems are designed to ISO requirements (ISO 14644), thus providing air of high quality with respect 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 maintained effectively between adjacent rooms to prevent ingress of particulates (viable and non-viable)
• Temperature and relative humidity control is provided through an energy efficient air conditioning system and dehumidifiers, ensuring stability of environmental condition during manufacturing, which is extremely important for synthetic absorbable sutures
• The clean rooms have been constructed with non-particle shedding modular panels made of powder coated GI sheets with polyurethane foam at its core, ensuring airtight clean rooms, better insulation and ease of maintenance. Epoxy flooring and covings at all corners provide smooth surfaces and prevent generation and accumulation of dust. It also prevents settling and harboring of micro-organisms incorners and crevices
• The clean room clothing is pre-sterilized (by autoclaving). It is provided to all personnel 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 entry of contaminants into the clean room facility
• All doors and windows are flushed with walls on both sides. The door and window frames are equipped with non-particle shedding gaskets to make them airtight
• Door Interlocking System is provided in all critical areas to avoid cross contamination and to prevent unauthorized man-material entry

All the above features contribute significantly in reducing the bio-burden and particulates on the product prior to sterilization. This helps us produce a risk-free, sterile product that can be used with confidence by the surgeons.