Ethylene oxide sterilizer designed, manufactured and validated in accordance with manufacture standard YY 0503-2015 ETO sterilizer classification and requirements.
Validation standard: GB 18279.1-2015 (health care sterilizing- ETO- part 1: medical device sterilizing process development, conformation and normal control requirements).
Quality system standard: ISO 13485-2016; YY 0287-2016 (medical device quality system).
Providing software confirmation report with reference standard FDA-21CFR part 11.
Capacity: 10 pallets on the floor, 20 pallets double stacked.
Pallet size: 40 inches wide x 48 inches long x 40 inches tall.
Sterilizer Sections
Mechanical section: sterilizer chamber, heating system, vacuuming system, EO injection system (EO vaporizer), humidifying system, air change system.
Electrical control section: hardware of the control system, control system software description, independent data report management system, software verification, on-site installation, sterilizer control mode, software warning system, control software process, power failure protection.
Mechanical Section Details
Sterilizer chamber:
Cabinet structure: main body of the cabinet is fully welded; the inner cabinet, door frame, heating water jacket are covered by a heat insulation layer and outer plate.
Heating mode: uses method of hexahedron heating (four sides of the sterilizer chamber and two doors have water jackets) and combines the grouping and adjustable method to guarantee an even heating rate and temperature.
Process nozzles: only for testing, not for sterilization; test nozzles are made of stainless steel pipes, each equipped with stainless steel handball valves.
Components, pipes and accessories: all pipes in contact with ethylene oxide gas are made of stainless steel 304; all sealing gaskets and seals in contact with EO gas are made of polytetrafluoroethylene or silicone rubber.
Sealing door: pneumatic sliding; door seal is made of silicone rubber; with nitrogen filling, with a non-return valve during power failure to avoid gas leaking; vacuum system does not operate when door is opened; has pressure test function. Door type options: M (mechanical door, out of use), A (pneumatic sliding door), R (pneumatic revolving door), L (lifting door).
Sterilizer cabinet sizes: common volumes are 78L, 150L, 230L for hospital and laboratories; 1m³, 2m³, 3m³, 5m³, 8m³, 11m³, 15m³, 20m³, 26m³, 35m³, 40m³, 50m³, 60m³, 75m³, 90m³, 100m³ and 120m³ for medical product manufacturers or sterilization companies; any size can be customized.
Door (main part): door: stainless steel SS304, δ=8mm; door frame: rectangular steel 120 x 60/Q235; door water jacket: U-bar carbon steel; door sealing flange: GE: stainless steel; door: stainless steel SS304, δ=8mm; housing: stainless steel SS304, 1.2mm; insulation: ceramic fiber; door seal: silicone rubber internal feeding air 30-60°C, automatic control.
Heating system:
Heating water tank is placed on the wall of the sterilizing cabinet and connected by a steel frame; electric heating, circulation pump, temperature sensor, automatic water supplement and each water interface are integrated.
Heating water tank parameters: stainless steel, explosion-proof electric heating tube x 1; water tank: SS304; thermal insulation: fire resistant rubber plastic board 30mm; cover: stainless steel 430, δ=1.2mm; connecting pipe: galvanized pipeline; filter: stainless steel filter; a liquid level sensor, pneumatic ball valve control automatic feeding, water overflow, manual drainage.
Heating circulating system: hot water tank heats water to a predetermined temperature by stainless steel explosion-proof electric heater, monitored during sterilization by computer (temperature sensor); has function of supplying water automatically and holding temperature; water jacket distributes water evenly; heating area is bigger than non-heat area; total of 4 running back water pathways with valves to ensure heating rate and temperature uniformity.
Circulating pump: sterilizer is heated by hot water from the water tank through a filter; runs hot water in the water tank continuously to control sterilizer temperature.
Vacuum system:
Has a pre-vacuum (for first time and for negative pressure leak test and for getting rid of oxygen), removes and cleans EO gas in the sterilizer; discharge port connects to steam water separator and waste gas treatment equipment.
Vacuum pump is a single-pole vacuum pump and uses a step method to adjust the vacuum rate.
Injects EO gas / EO + CO2, or N2 gas when using pure EO to sterilize.
Vaporizer: uses pump to transfer heat to vaporizer to make EO change from liquid to steam; vaporizer liner: stainless steel; EO coil pipe: stainless steel pipe SUS304; vaporizer housing: stainless steel; insulation: fireproof aluminum silicate fiber blanket; heating method: main hot water tank supply.
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