製薬機械（装置）

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. When hot air temperature up to 170°C~260°C then reduce temperature the chamberr inside the bottle, appliance, aluminum cover and rubber stopper (Low temp.) completed non germ and in according with the cGMP requlations. 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, correspondence with cGMP requirement.

Features:

• The quality dependable, in according with cGMP requlation.
• Absolute high temperature (750°F) and high efficiency hepa filter (DOP. Test 99.97%), ensure air class within 100 (use hot air effect hepa filiter to filter after enter chamber will complete sterilize bacteria, charmber inside bacteria quantity below 6 log
• Intake/ exhaust choice 99.97% filter dervice to use.
• Charge DOP, particle counter tets hole and validation testing holes are available for inspection.
• 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.
• During sterilizer process, the charmber inside empties temp within ±5°C.
• Every filter has one pressure gauge check two-side the pressure and check filiter within.
• Intake / exhaust has one damper can compete control every cycle open and close.

Control System:

Hot air sterilizer system use human machine interface touch screen (LCD with color) and PLC sequence controller easy to operate and maintain, operation panel can set up several type of display information, according the screen description to operate, adjust or install the machine.

1. By temperature recorder to record continuous cure of the chamber sterilization process, can choose 6 points or 12 points.
2. Automatic sterilizer cycle including heating --> drying --> sterilizing --> cooling --> finishing etc. five stages.
3. Prevent hot temperature and bottle break when cooling cycle not yet finish the door can't open.
4. Option purchase equipment to check chamber during turning is regular condition and recorder display pressure value.

Construction:

• This machine is designed and fabricated by high quality technique, all construction materials are made of AISI 304, or 316L stainless steel and comply with cGMP standard.
• Sealed door packing use ring silicone rubber material, ensure hot air no leakage.
• Adjustable inlet and outlet damper for chamber heat distribution.
• Sealed interior chamber (argon welding) and stainless steel chamber permit washing the chamber.
• Single door or pass through type double door available.
• Auto controller has two temp control ensure operate safety.
• The sterilizer has two-door design that seoarates the sterilizer from the washing room and sterilized room.
• The bottle loading are from washing room side after sterilization completion products unloading are only from sterilizing room side.
• The door control use interlock device to avoid different air class causing contamination.
• Sterilizer trolley use stainless and sterilizer tray can in harmony with filling machine use.

Specifications: