Details:

Technical Plan

1. Standards for Sterilizer Manufacturing and Validation

This type of epoxy ethane sterilizer is designed, manufactured and validated in accordance with the following standards:

1. ISO13485-2016 medical device quality management system.
2. EN1422-2014 ethylene oxide sterilization requirements and test methods.
3. 2006.95.EC low voltage directive.
4. 2006.42.EC machine directive.
5. 94.9.EC ATEX 95 equipment directive.
6. EN1127-1:2019 explosive atmospheres. Explosion prevention and protection.
7. YY0503-2015 classification and requirements for ethylene oxide sterilizers.
8. ISO11135-2014 EO development, validation and routine control of sterilization.
9. FDA 21 CFR Part 11 electronic record and electronic signature.

2. Sterilizer is made main by two parts:

A. Mechanical Part

1. Sterilizer chamber;
2. Heating system;
3. Vacuuming system;
4. EO injection system;
5. Humidifying system;
6. Air change system.

B.Electrical Control Part

1. Hardware of the control system;
2. Control system software description;
3. Independent data report management system;
4. Software verification;
5. On-site installation;
6. Sterilizer control mode;
7. Software warning system;
8. Control software process;
9. Power failure protection.

3. Sterilizer:

A. Mechanical Part

1 Sterilizer Chamber

1.1 Chamber structure: The main body of the chamber is welded by the inner pot, 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 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.

1.4 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.

Door type（ optional） door with variety of structure sealing form:

1. M: Mechanical door(old model, out of use)

2. A: Pneumatic sliding door

3. R: Pneumatic revolving door

4. L: Lifting door.

1.5 Sterilizer chamber size:

Our sterilizer common volumes:

1. 78L, 150L, 230L for hospital and lab.

2. 1m3, 2m3, 3m3, 5m3, 8m3, 11m3, 15m3, 20m3, 26m3, 35m3, 40m3, 50m3, 60m3,75m3, 90m3, 100m3 and 120m3, for medical product manufactures or sterilization stations. Please note, any size can be customized.

This sterilizer specification:

1.6 Main Structure Material

Chamber Body (Main Part)

Door (Main Part)

2. Sterilizer Heating System

The heating system is heated by the central heating system

2.1 The heating water tank is installed on the wall 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 heating method: Electricity, industrial steam, natural gas(a extra boiler is needed).

2.2 Heating system water tank specification:

2.3 Heating Circulating System

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 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.

Vacuum brand: BE: Yanfeng; LE: Yanfeng: GE: SIHI/Nash.

4. Sterilizer - EO Injection System

EO injection system would inject EO gas/ EO + CO2; if pure EO gas is used, the N2 gas would injected through the EO injection system too.

4.1 Vaporizer: Structure and Material

4.2 EO Injection Arrangement

4.2.1 If without internal circulation fan: the top of the cabinet has three EO injection holes; the injection mouth is easy to take apart for cleaning; if there’s internal circulation fan, EO injection only need one.

4.2.2 Vaporization pump: the hot water in the main water tank is transported to the vaporizer.

4.2.3 The EO injection 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).

5. Sterilizer - Humidifying System

The humidification system adjusts the humidity in the sterilizer by injecting saturated steam.

5.1 The steam generator is configured by 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.

5.3 Humidifying system can start humidifying process by two ways: humidity sensor and pressure difference method.

6. Sterilizer - Air Displacement System

Replace air is the air system for injecting filtered air

6.1 The air replacement 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 μm, and the 1 core filter is used to shorten the air replacing time to the maximum.

6.3 The fresh air is incorporated into the internal circulation duct and enters the sterilizer.

B. Electrical Part

The control operation system of the sterilization cabinet will achieve automatic control of the sterilization process, with stable and reliable operation.

1. Hardware of the Control System:

1.2 Control System

There are three system options:

1. Integrated control system: BGIB3-EO
2. IPC separate system: BGD83-EO
3. Control system: (only for BE series)

Buyer can choose either BGIB3 or BGD83 as what they want. BGIB3 is more popular. BGD83 is normally for the buyers, who have limited space to make a separator control room in the workshop, so the computer can be moved out side of the workshop to office.

2. Control System Software Description:

Operation system: Windows 10 operation system.

Control system: EOCS.

2.1 The control system of the sterilizer can set 4 level password，which authorizes the operators, administrators and maintenance level respectively. Each user can set the username and password independently.

2.2 The control system of sterilizer can support more than 100 sterilization recipes.

2.3 Monitoring and management system of computer will provide on time alarm when the temperature, pressure, humidity and other parameters changes not normally, such as water temperature, ultra high temperature sterilization temperature ultra high temperature sterilization temperature, ultra low temperature pressure and ultra high pressure sterilization, ultra low pressure gasifier temperature, humidity and ultra-low humidity …were recorded in bacteria parameter report clearly and displayed separately.

2.4 Sterilizer supervisor management system, can continuously showing, collecting, and recording daily sterilizing data, which need to be supervised( sterilizing temperature T1, sterilizing temperature T2, sterilizing pressure P1, sterilizing pressure P2, sterilizing humidity RH1, water tank temperature T5, EO temperatureT6, EO vaporizer T7).

2.5 Sterilizer monitoring management system, which can print historical trend map in the form of free combination, supports the direct conversion of historical trend map to PDF output.

2.6 Detailed Description:

3. Independent Data Report Management System

3.1 Data exception points can be collected and recorded.

3.2 It can implement process data record mode, never lose key parameters.

3.3 Automatically generate sterilization batch record.

3.4 Support the setting of different recording time intervals at different stages, save the printing paper, reduce the records of redundant data, and facilitate the auditor's review.

3.5 Batch record summary can be generated automatically, and the qualified situation of sterilization can be determined automatically in advance, which can greatly reduce the labor intensity of data audit personnel of sterilization record, and can reach the level of parameter.

3.6 Supports direct conversion of data format to PDF output.

3.7 Detailed data recording function is supported. The range of record parameters can be selected as: T1, T2, T5, T6, T7, P1, P2, RH1.

3.8 Support process time automatic summary function, running process data automatic summary function, product list entry and management function.

Data Report System: Detailed Data Record Function

4. Software Validation:

The standardized system can provide professional software verification report free, and the non – standard system software verification report will be charged extra.

5. On-Site Installation:

The on-site standard specialties installation makes the system more stable.

6. Sterilizer Control Mode:

Sterilizer control mode: by switching, soft manual and full-automatic.

7. Software Warning System

For safety purpose, the system has more than 100 alarm or reminding.

7.1 The alarm system is divided into two types: normal work and abnormal fault alarm.

7.2 The alarm system will record all the working tips and fault alarm of the system

7.3 The alarm system intelligently judges the types of the alarm and produces the corresponding text hints, and the normal operation and simple trouble shooting method can be found through the operation manual.

7.4 Work warning project: high and low water level fault, sensor fault, door seal low pressure, low compressed air, low steam pressure, low vacuum feeding water, low or high vaporizer temperature, low temperature of EO injection, EO injection start, EO injection finish etc. Totally there are about 100 alarms.

7.5 Automatic operation process fault alarm, fault item: failure of vacuum pump, circulation pump failure and vaporization pump failure, abnormal temperature of sterilizing room, abnormal hypothermia in sterilizing room, abnormal high temperature of water tank, abnormal high temperature of vaporizer, abnormal leakage of sterilizer body and abnormal high pressure of cabinet, EO absolute low temperature, bearing abnormal temperature of circulating fan, abnormal speed of circulating fan and so on.

7.6 The control program has remote interactive function with the user terminal and provides remote technical service.

8. Control Software Process:

8.1 Ethylene oxide injection amount: the injection amount can be controlled by differential pressure method or weight method according to the technical standard of the demander.

8.2 Sterilization time: automatic control, according to the requirements of the process.

8.3 Sterilization process flow: sterilization process flow is the standard version of the routine process as follows:

Heating - heat preservation-vacuuming- leak detection- humidification-humidification balance-dosing-sterilizing (EO exposure)-air cleaning-removing residual- sterilization cycle end (open and unload sterilized products).

9. Power Failure Protection:

9.1 The power failure protection device can keep the door seal seals gassing working condition.

9.2 Sterilization software itself has the function of power failure protection. Control power reconfigure UPS, and continue to monitor sterilization parameters and record data during the UPS working period.

Requirements for On-Site Construction Supporting Facilities: Customer is responsible for it.

1. Option of ETO workshop supporting equipment (the client chooses according to the current situation, and this item is not included in the quotation).

2. Requirements for auxiliary facilities outside the ETO workshop: Customer should be responsible

- Building requirement: Workshop height is at least 4.5meters, workshop door should be at least: width x height=3m x 3m, the factory should be well ventilated, well lighting and emergency lighting, all electrical appliances incorporate explosion - proof grade, (there is a disinfecting device for the import and export of personnel, and a disinfecting filter device for the import and export of goods).

- Ground requirement: The ground should be flat, can bear 2t/m2 pressure, concrete pouring, and a pit in the sterilizer position (depth 270mm please refer to workshop layout), with grounded device. The floor of the workshop is covered with floor paint, which has special safety channel identification.

- Environment: The environment temperature: 5 ℃ to 40 ℃. Relative humidity: 75% or less RH. Atmospheric pressure: 80kPa.

- Power Requirement:

380V, 50Hz, three-phase five wires 25 square international wire.

- Water requirements: Heating water: DN25 pure water pipeline, water pressure more than 2kg, valves and pressure gauge. (Municipal water pipeline DN25, water pressure more than 3kg, factory has your own filter). Humidifying water: Pure water pipeline DN15, water pressure more than 2kg, with valves and pressure gauge.

- Steam requirements: Filter, remove water, adjust pressure to 4kg, with valves and pressure gauge.

- EO gas: EO percentage range 30%~100%; each cycle each cubic meter will consume about: 0.6~0.8kgs EO gas. If 100% EO gas is used, nitrogen gas is strongly suggested to wash the sterilizer chamber before EO injection.

- Discharge and drainage: There is a water outlet near the bottom of the cabinet and the control room for regularly discharging the circulating water and body water of the sterilizer. The waste gas adopts the waste gas treatment device of our factory or the seepage pool of the outlet water pipe road.

3. Site construction requirements: The buyer prepare:

4. Project Progress:

Spare Part:

GE series spare parts list V1.7

Documents Will Be Provided:

1. Company profile, qualification certificate

2. Product list

3. Producing-in-process inspection record

4. Safety notification, safety operation manual, daily maintenance.

5. ETO sterilizer operation instruction. (Operation instruction, mechanical drawing, electrical drawing, common troubleshooting table).

6. Auxiliary information, qualification certificates.

7. Sensor validity certificate, qualification certificate (if need the third party test certificate, please notify).

8. Provide software validation reports, functional validation.

9. Provide IQ/OQ validation.

Drawing or diagram: layout, schematic diagram, general assembly diagram.

Function List of LE Series and GE Series:

The Series Sterilizer Control System Functions List

These three series are different. Customers can choose one series according to functional requirements.

- GE series has the highest price because of its high configuration, full functions and the most detailed reports. To use IPC to operate.

- LE series, can meet the needs of most customers, price is lower than GE. To use IPC to operate.

- BE series function is simple. Touch screen to operate.

Customer List (Just a Few Customers for Example)

Our sterilizers has be sold to more than 30 different countries. The volume of the sterilizers is from 1 cbm to 120cmbs. Our sales in the past 5 years, annual sales quantity is 260 sets.

Magnetic Fan (Only for Sterilize ≥30m3)

Water Jacket (GE Series)

ETO Sterilizer: