Manufacturing and validation standards of implementation

Design, manufacture and verification refer to the following standards:

EN1422-2014 YY0503-2016《ETO STERILIZER》

ISO11135-2014 GB18279-2015《Sterilization of healthcare products - ethylene oxide - part 1: development, validation and routine control requirements for sterilization of medical》

Reference standard for software confirmation report: FDA-21CFR PART 11 and relevant FDA regulations and guidelines.

All equipment, spare parts, purchased parts, materials and specifications provided are in accordance with the relevant industry and national standards

Preheating room technical program

a、 Preheating room main structure

Preheating room size (length * width * height): 8000*1500*2300=27.6m3, one room

1、 The main structure is built by the demander( thickness no less than 75mm, density not less than 80K, high strength, class A fireproof silica rock plate, double colorful plate with 0.5mm, seamless connection fixed, with ladder for daily maintenance);

2、 The door(provided by the demander) is made of plate as above, the door frame is fitted with a bumper, four frame inlaid sealing tape, ensure maximum sealing. The door head is fitted with a wind curtain, door width 1.35m, manual double open door, one door for loading and one door for unloading.

3、 Install 2 moisture-proof and explosion-proof lights on the top, with automatic switch;

4、 There are working indicator lights in each preheating room, indicating starting and stopping;

5、 The air duct shall be prepared by demander(It is recommended to use 0.6mm thick stainless steel or galvanized iron sheet, exterior insulation class B1, 20mm rubber and plastic plate).

b、Heating system:

1、 Industrial steam heating;

2、 Adopt heating and humidifying integrated air cabinet, copper tube aluminum fin heat exchanger. The air volume is 1000m³/h, the air pressure is 350pa, and the fan is 0.5kw. The preheating room is equipped with one set, the circulating amount in the room is no less than 30 times /h to improve the thermal efficiency.

3、 Each set of wind cabinets is mounted on the preheated roof and hoisted by steel frame, 10 air supply outlets and 4 air return outlets, 10 air regulating valves, 14 guide windows, heat preservation seal treatment, can adjust the wind volume and wind direction;

4、 Preheating room maintains a slight positive pressure after starting the machine, combined with the circulation of wind action to heat exchange, heat conduction, thermal penetration also ACTS on preheated items.

c、Humidification system

1、 The stainless steel steam generator supply water automatically;

2、 The steam source shall be reduced to 2-4kg humidified, controlled by corner valve. Condensate is leaded to a drain through the trap.

3、 Steam enters the air duct through the filter and feeds to the room, blew through each fan to each outlets.

4、 The steam pipe and valve are all made of stainless steel. Needle valves control flow.

5、 A steam engine should supply pure water, other water source can’t be used to humidify.

d、Control system

1、 The preheating room is equipped with two temperature and humidity probes, to provide reliable data for the control system, make the preheating room temperature and humidity control accurate, and also display and monitor the room temperature and humidity.

2、 The control system adopts IPC and PLC control method, the whole process is fully automatic and can be recorded and printed as required: date, time( minutes ~ hours), lot number, product number, operator, temperature and humidity data, trend chart, historical graph. And all these data can be saved for 5 years (software refer to sterilizer);

3、 Intelligent and humanized operation interface to prevent mis-operation function, batch remind function, and parameter alarm function;

4、 Specialized electric control operation desk, liquid crystal displaying preheat setting parameters and real-time parameters, indicating switch, emergency stop button and fault alarm;

5、 The recorded data cannot be modified, when the software is updated, all data can be exported, saved, and sent back to the system to get the data;

6、 When the software parameters are modified, they are automatically recorded in the software operating system.

e、The performance parameters:

Item	Name	Parameters	Note
1	heating capacity	PDI heating mode, automatic switching, ensure the heating capacity and efficiency; The end of circulating water loop is equipped with valve to adjust water flow; Automatic heating by temperature control, temperature control can be set; Initial temperature 10 ℃ heating to 45 ℃ take time ≤2h; Room temperature distribution; the maximum average or average - the minimum ≤ 5 ℃; Humidity distribution:30-80%RH； If there are more than one room, consider the temperature and humidity distribution of each room should be roughly the same.
2	heat preservation performance	To adopt silicon rock plate, strong thermal insulation performance; the surface without temperature sensitivity
3	Work pressure	The micro positive pressure
4	Humidifying capacity	Pulse humidification or continuous humidification 30%RH-60%RH ≤ 30min, humidity uniformity ≤±10%RH;
5	Power load	Three-phase five line 380V, 50HZ, the actual load 30kw.

f、Configuration list:

Configuration list
Item	name	material	P/N	parameter	QTY	Note
1	Main material	Silicon rock plate	75mm	Double 0.5mm high density slilicon rock colorful plate	≈150㎡	Customer prepare by themselves
2	Door	Silicon rock plate		Width 1.35m	2pcs/room	demander prepare by themselves
3	Heating humidifying wind ark		BFP-10WD	1000m³/h air volume 0.5kw	1pc/room	integrated
4	wind curtain machine		1.5m	0.3kw	2pcs/room	One for each door
5	Control system	Carbon steel spraying paint	Special purpose for preheating room	Siemens IPC, PLC, Schneider electric	1 set	Two aeration rooms share one set
6	Temperature and humidity sensor			0-100℃	2pcs/room	Control temperature and humidity
7	Artificial materials				Some	For construction
8	Guide window				14pcs/room	Quality adjustable
9	Wind valve				10pcs/room	Quality adjustable
10	Air duct insulation			0.6mm SS or iron sheet, 20mm rubber and plastic heat preservation	some	Quality adjustable
11	Steam generator				1pc/ room

Preheating Room Technical Program For 20m3 Eto Sterilizer

Publish Time：2023-10-19