Maintenance of sterilizer equipment
Preventive maintenance shall be planned and implemented in accordance with documented procedures.
Procedures shall be documented and maintenance personnel shall be trained.
Only after all specified maintenance tasks have been satisfactorily completed and documented can the equipment be used for processing products.
Equipment to be maintained and/or calibrated on a routine basis can include, but is not limited to, the following preconditioning, chamber and aeration equipment:
- 1)EO monitoring equipment (i.e. environmental and/or chamber);
- 2)temperature and humidity sensor equipment;
- 3)chamber jacket re-circulation system;
- 4)chamber jacket system;
- 5)weighing scales;
- 6)pressure transducers;
- 7)valves;
- 8)timers;
- 9)recorders;
- 10)gaskets and seals;
- 11)monitoring gauges;
- 12)door safety interlocks;
- 13)filters (for periodic replacement);
- 14)air/gas circulation systems.
- 15)safety pressure relief valves or rupture discs;
- 16)audible and visual alarms;
- 17)volatizers/vaporizers;
- 18)boiler system for steam and heat supply;
- 19)evacuation equipment (vacuum pumps);
Records of maintenance shall be retained
The maintenance scheme, maintenance procedures and maintenance records shall be reviewed at specified intervals by a designated person and the results of the review shall be documented.
It is necessary to periodically review the maintenance records and to make any adjustments that are indicated by the data.
Mechanical Part of EO Sterilizer
1,Sterilizer main cabinet，
2,Heating system，
3,Vacuuming system，
4,EO feeding system，
5,Humidifying system，
6,Aeration system.
Mechanical Part of EO Sterilizer
1 sterilizer chamber
1.1 Cabinet structure: the main body of the cabinet is welded by the inner cabinet, door frame, heating water jacket, covered by heat preservation layer and outer plate.
1.2 Heating mode: use the method of hexahedron heating and combine the grouping and adjustable way to guarantee the heating rate and temperature.
1.3 Process nozzles: only for testing, not for sterilization. The test nozzles are made of stainless steel pipes, and one of them is equipped with stainless steel handball valves.
1.4 Components, pipes and accessories: All pipes, which would contact ethylene oxide gas, are made of stainless steel 304; and all of the sealing gaskets and seals, which would contact EO gas, are made of polytetrafluoroethylene or silicone rubber.
1.5 sealing door： The doors of the sterilizer are pneumatic sliding; the door seal is made of silicone rubber; nitrogen filling, with a non-return valve during power off avoiding the gas leaking; no need to brush oil; no need to vacuum when open the door and it also has the pressure test function.
2 Sterilizer——heating system
The heating system is heated to the sterilized cabinet set temperature.
2.1 The heating water tank is placed on the top of the sterilizing cabinet and with the steel frame connected. Electric heating, circulation pump, temperature sensor, automatic water supplement and each water interface are integrated.
2.2 The parameters of the heating water tank.
2.3 heating circulating system
2.3.1. Hot water tank: The water is heated to a predetermined temperature by stainless steel explosion-proof electric heater, and is monitored during the sterilization process by computer (temperature sensor); It has the function of automatic water supply, and hold temperature; water jacket distributes evenly. Heating area is bigger than the non-heating area. Totally there are 4 running back water ways with valve to ensure the heating rate and temperature uniformity.
2.3.2. Circulating pump： The sterilizer is heated by the hot water from the water tank through the filter. Running the hot water in the water to tank continuously to control the temperature of the sterilizer, and control the water temperature in the tank to control the sterilizer temperature.
3 Sterilizer--vacuum system
The vacuum system pre-vacuum, remove and clean the EO gas in the sterilizer. Discharge port connects to the steam water separator, and waste gas treatment equipment.
a) The vacuum pump adopts single-pole 5.5kw junze vacuum pump, and USES step method to adjust the vacuum rate.
b) Vacuum device: pneumatic ball valve, check valve. Prevent negative pressure backwater, prevent power failure backwater function.
4 sterilizer——EO injection system
EO injection system feeds EO gas/ EO + N2.
4.1 Vaporizer：structure and material,
4.2 EO feeding device
4.2.1 The top of the cabinet has 3 EO injection holes；The feeding mouth is easy to take apart for cleaning;
4.2.2 Vaporization pump: the hot water in the main water tank is transported to the vaporizer.
4.2.3 The EO feeding mouth of the sterilization cabinet is equipped with an independent control temperature sensor; EO temperature is a super low, the system will alarm and stop dosing.
4.2.4 The EO input can also be weighed and controlled according to the pressure difference control in the sterilizer.
4.2.5 EO input pipeline: filter, pneumatic ball valve, flow meter, pressure gage. The pipe is equipped with the removal of the residual EO device (to the exhaust gas treatment system, exhaust gas when the cylinder is replaced)
4.2.6 The EO vaporizing water tank needs to be separated.
4.2.7 The water tank needs to have bottom valve.
5 sterilizer—humidifying system
The humidification system adjusts the humidity in the sterilizer by adding saturated steam.
5.1 The steam generator is configured by 6KW steam generator; automatic water replenishment, automatic heating and automatic protection.
5.2 Humidifier: filter (5 inches) division of water removal, trap, pneumatic ball valve, needle valve, steam from the side of the cabinet into the humidifier, 2 humidifier holes.
5.3 Humidifying system can start humidifying process by two ways: humidity sensor and pressure difference method.
6 Sterilizer——air change system.
Changing air system is the air system for feeding filtered air。
6.1 The air change device includes the handball valve, the pneumatic ball valve, the explosion proof proportional valve (control rate), the precision filtration and the coarse effect filtration.
6.2 The precision filter is pre - coarse filtering, which can fully prolong the service life of the rear precision filter. The filter precision is 0.3 Um, and the 1 core filter is used to shorten the air changing time to the maximum.
6.3 The fresh air is incorporated into the internal circulation duct and enters the sterilizer.
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