Autoclave (Hinged Door)
Sterilization (or sterilisation) in 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.
PHARMALAB STERILIZER
Our sterilizer has been engineered to meet the stringent manufacturing standards, like cGMP, EN285 (European), MHRA (UK), FDA (US), being followed by the Pharmaceutical & Bio-tech industries, Pharmalab 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
- PHARMALAB Quality system Approved by BVQI : ISO 9001 – 2008 Quality Management System.
- ISO-13485:2003 Quality Systems for Medical Devices
- The design and construction to comply with Good Manufacturing Practice (cGMP)
- Design and Construction as per ASME code. Authorized to use “U” and “R” stamp
- Approved & Certified design CE (PED -2014/68/EU)
- Compliant to EN285
FEATURES
- Control system as per 21CFR part 11.
- Dimple jacket of SS 316L provided for enchanced / uniform and temperature distribution (within ±1oC during the sterilization phase).
- 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.
- 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).