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Hot air sterilizer machinery designed according to forced convection principle with fast hot-air transmission circulation, and then through HEPA FILTER ensures the chamber air class within 100. Chamber inside the bottle , appliance, aluminum cover, rubber stoppers( completed non germ when hot-air temperature up to 170℃~ 260℃ then reduce temperature, in accordance with the cGMP regulations. Before the machine leave the factory finish whole testing, Provide equipment IQ & OQ data manual, and all instruments calibrating report such as sheet document, contain varied kind of gauge and Temperature sensor, Provide original CALIBRATION document, in according with cGMP requirement.
Use for Pharmaceuticals/ Biotechnology/ Electronics/ Chemicals/ Foods etc. Mainly use for glass metal sterilizer and hot source effective. Such as vial, ampoule, injection bottles, aluminum cover etc.
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1. The quality dependable，in according with cGMP regulation.
2. Absolute high temperature(750℉)and high efficiency Hepa filter(DOP. Test 99.97%), ensure the chamber air class within 100. (Use hot air effect Hepa filter to filter after enter chamber will complete sterilize bacteria, chamber inside bacteria quantity below 6 log (10-6)
3. Intake/ exhaust choice 99.97% filer device to use.
4. Charge DOP, particle counter test hole and validation testing holes are available for inspection.
5. Prepare a validation hole to make Quality Assurance people test the FP/FH value of the chamber between the heating distribution and the heating penetration.
6. During sterilization process, the chamber empties every position temp. within±5℃.
7. Every filter has one pressure guard check two-side the pressure and check filter life.
8. Intake /exhaust has one stop-door can compete control every cycle open and close.
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1. This machine is designed and fabricated by high quality technique; all construction materials are made of AISI 34, 316, 316L stainless steel and comply with cGMP standard.
2. Sealed door packing use ring silicone rubber material, ensure hot air no leakage.
3. Adjust type inter/exhaust fender.
4. Sealed interior chamber (Argon welding) and stainless steel chamber permit washing the chamber.
5. Single door or pass through type double door available.
6. Auto controller has two over temperature protect to ensure operate safely.
7. The sterilizer has two-door design that separates the sterilizer from the washing room and sterilized room.
8. Bottles are to be loaded into the washing room and to be sterilized by the sterilizer and loaded out to sterilized room.
9. The door control use interlock device to avoid different air class causing contamination.
10. Sterilizer trolley use stainless and sterilizer tray can harmony with filling machine use.
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