Work Environment

The manufacturing and packaging of our medical devices are carried out in a highly hygienic atmospheric condition.
Fumigation is carried out in the production, packaging area at weekend to control the bio-burden level
The production area is totally enclosed and the air handling system is introduced.
Class 10,000 clean room is maintained at Microbiology lab and air conditioning is maintained at the Quality Control Lab and the microbiological tests are carried out under class 100 Laminar Air Flow.
Raw materials, Semi-finished material, and finished materials are stored in highly hygienic condition.
The bio-burden levels check on in the product and atmosphere is conducted periodically in accordance with ISO 11737-1:2018 “Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products”
The “cleanroom” is validated according ISO 14644 series.
Training programs are implemented for cleanroom personnel.

The walls are repainted at the planned frequency. The AHU and LAF are maintained in good condition and validation is carried out in defined frequency.
Pest control measures are taken to ensure freedom from insects and rodent attack.

Housekeeping is maintained throughout the production and packing operations.
Mopping of all critical area like manufacturing, packaging, quality control laboratory etc., is carried out with disinfectant at fixed intervals.
No sweeping is allowed inside the factory. Only mopping is conducted in the critical areas.
All drains are cleaned regularly and disinfected.
Toilets, change rooms, and washing areas are cleaned frequently using disinfectant solutions.
Machinery is cleaned daily to remove any foreign materials.
Windows, fans, lightings, and walls of the rooms are cleaned at regular intervals.