Sterilization is simple terms, refers to any process that effectively kills or eliminates transmissible agents (such as bacteria, viruses, spore forms etc.) from a surface, equipment or biological culture medium.
Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Of these, heat (steam) sterilization is proven to be the most effective.
A minimum temperature-time relationship must be maintained throughout all portions of load to accomplish effective sterilization. Exposure time depends upon size and contents of load, and temperature within the sterilizer. At the end of the cycle, re-evaporation of water condensate must effectively dry contents of the load to maintain sterility.
Our sterilizer has been engineered to meet the stringent manufacturing standards, like cGMP, being followed by the Pharmaceutical & Bio-tech industries, we believes in “Total Quality” and “Total Customer Satisfaction”, hence manufacturing is in accordance with GAMP & ISO 9001 guidelines & our providing of documentation (Like DQ, OQ, IQ) enables customer to meet the above standards.
CERTIFICATION, GUIDELINE AND STANDARDS
- The design and construction to comply with Good Manufacturing Practice (cGMP)
- Design and Construction as per ASME code.
FEATURES
- Control system as per 21CFR part 11.
- Bioseal: A biological safety barrier separates the sterile and non-sterile zone.
- Integration of sterile section with isolator.
- Machine gasket groove for the door.
- Air detection system for porus load.
- Rack & Pinion arrangement for door movements.
- Pneumatic cylinder movemant
- Seal water recirculation arrangement.
- Temperature control through PLC using floating sensor mechanism.
- Electric Steam Generator (Optional).
- Provided with Pure steam sampling arrangement with heat exchanger for easy draw of sample in aseptic and safe temperature condition(Optional).
