ECMC - Model ECHS-01 -Hot Air Sterilizer for Class 100 Environments

FromECMC (E CHUNG MACHINERY CO.)

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The Hot Air Sterilizer by ECMC (E CHUNG) ensures sterilization within Class 100 cleanroom standards, leveraging a forced convection design that circulates air through a HEPA filter to achieve rapid thermal conditioning. Operating within a high temperature range of 170 to 260°C, this equipment is engineered for precise sterilization of materials such as bottles, aluminum caps, and rubber stoppers, in compliance with current good manufacturing practices (cGMP). Tailored to cater to the stringent requirements of the pharmaceutical and biotech sectors, it supports both standard and custom specifications. ECMC integrates advanced control systems to track and manage temperature curves, ensuring reliable and consistent sterilization outcomes. The design focuses on adherence to international standards, thereby maintaining equipment efficacy and safety in medical manufacturing and processing environments.

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To ensure Hot Air Sterilization inside of the chamber is within Class 100 , it's designed in accordance to the principle of forcing convection, passing through HEPA filter, and the speed of hot air transported circulation is fast.

When the hot air temperature is reached 170 ~ 260°C, the internal temperature will be decreased, and the bottles, appliances, aluminum caps, and rubber stoppers (low temperature) are completed sterilized and comply with cGMP regulation.

The quality is dependable in according with ISO 9001 and cGMP regulations.
Absolute high temperature (398℃) 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).
Intake / exhaust choice 99.97% filter device to use.
Charge DOP, particle counter test 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 sterilization process, the chamber inside empties temp. with ± 5℃.
Every filter has one pressure gauge check two-side the pressure and check filter life.
Intake / exhaust has one damper can compete control every cycle open and close.

Apply for Pharmaceuticals / Biotechnology / Electronics / Chemicals / Foods industries, etc.
Mainly use for the glass & metal sterilizer and hot source depyrogenation, such as vial, ampoule, injection bottles, various medical bottles, aluminum cover, and rubber stopper, etc.

This machine is designed and fabricated by high quality technique, all construction materials are made of SS304, 316 or 316L stainless steel and comply with cGMP standard.
Sealed door packing uses the ring silicone rubber material to ensure hot air without leakage.
Adjustable inlet and outlet dampers are for the chamber heat distribution.
Sealed interior chamber (Argon welding) and stainless steel chamber permit washing the chamber.
Single door or pass through type double door are available.
Auto controller has two Temp. controls to ensure the operation being safe.
The sterilizer has two-door design that separates the sterilizer from the washing room and sterilizing room.
The bottle loading is from washing room side after sterilization being completed and the product unloading is only from sterilizing room side.
The door control uses interlock device to avoid contamination being caused from the different air class.
Sterilizer trolley uses stainless and sterilizer tray can be harmony with the filling machine.