1. PURPOSE

1.1 To verify that the new ETO sterilizer (Serial Number: 201346 and Model: HMQ-100) is functional and

is capable of delivering the specified process within defined tolerances. It will confirm the ability of the

ETO sterilizer to operate effectively and safety.OPERATIONAL QUALIFICATION PROTOCOL

For HZBOCON 98.6 M 3Size ETO Sterilizer (S/N: 201346)

Used to sterilize Medical Devices Products

PROTOCOL#: ZSP-14-11 Jun 4th , 2014

1.2 This protocol defines the Operational Qualification (OQ) requirements and the corresponding

acceptance criteria for the 98.6 m 3 EO Sterilizers which installed at ETO sterilization facility xxx

medical product Co., LTD., which is located inxxx .

2. BACKGROUND

2.1 In order to expand capacity, A new 98.6 m3 ETO sterilizers are added and installed in the new ETO

sterilization facility of xxx China, xxx will use them to sterilize medical products.

2.2 The sterilizer is a 98.6 cubic meter chamber manufactured by HZBOCON Mechanical and Electrical

Equipment Co.Ltd . It is water-jacketed

with gas circulation system, it use 100% ETO gas as sterilizing agent, The sterilizer hold thirty (30)

pallets of size L1000mm x W1200mm x H120mm and the inner size of chamber is L16600mm x

W2700mm x H2200mm.

2.3 OQ study

2.3.1 This study will document operation of the chamber as well as document temperature and

humidity distribution characteristics within the chamber after this chamber has been installed.

2.3.2 The temperature and humidity distribution study will utilize sensors to conduct it per the

designated diagram in this protocol.

3. REFERENCE

3.1 ISO11135-1:2007 Sterilization of health care products — Ethylene oxide — Part 1: Requirements for

development, validation, and routine control of a sterilization process for medical devices

3.2 ISO11135-2:2008 Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the

application of ISO 11135-1

3.3 AAMI TIR15:2009 Physical aspects of ethylene oxide sterilization

4. RESPONSIBILITIES

4.1 Sterilization validation department

4.1.1 Sterilization Engineer will draft Operational Qualification protocol, gather supporting

documentation & data and review, write final validation technical report.

4.1.2 Sterilization QA director will review and approve validation protocol and final technical report.

4.2 Testing center

4.2.1 Responsible calibration personnel will prepare calibration procedure and complete calibration of

all relevant measuring device before installation qualification.

4.3 Equipment department

4.3.1 Install, set-up, and operate equipment for purposes of this study.

4.3.2 Provide technical support for any utility related issue.

4.4 ETO production workshop

4.4.1 Technician: Provide process and equipment documentation, provide technical support.

4.4.2 Operator: Assist for inspect equipment and collect relevant evidence.

4.1.3 Vice general manager: Review and approve validation protocol and final technical report.

5. DEVIATION AND CHANGE CONTROL

5.1 Deviation and/or change may happen during the qualification process. If it occurs, a corresponding

deviation form on Attachment A will be completed and submitted to the validation engineer for

disposition. The deviation form will describe the deviation / change, the impact to qualification,

resulting investigation, and action. The deviation form will be reviewed for acceptability and approved

by the personnel responsible for protocol approval. The deviation form will be the part of the

qualification report for final determination.

CONFIDENTIAL –

This document contains proprietary information that may not be reproduced or disclosed without written approval.

Page 2 of 26OPERATIONAL QUALIFICATION PROTOCOL

For HZBOCON 98.6 M 3Size ETO Sterilizer (S/N: 201346)

Used to sterilize Medical Devices Products

PROTOCOL#: ZSP-14-11 Jun 4th , 2014

6. TEST INSTRUMENTS AND MATERIAL

6.1 Total forty –two (42) temperature sensors and twenty-nine(29) dual sensors for both temperature and

humidity function are utilized to do temperature and humidity distribution study for empty chamber at

least according to the requirements of ISO11135-1. In fact, forty –four (44) temperature sensors and

thirty (30) dual sensors will be utilized to do the study.

7. OPERATIONAL QUALIFICATION PROCEDURE

7.1 Test Instruments and Calibration

7.1.1 All test instruments and equipment use in OQ should be within current calibration, and the

calibrations should be traceable to national standard. The following test instruments and

equipment shall be calibrated:

7.1.1.1 Temperature sensor (44pcs)

7.1.1.2 Dual sensor with temperature and humidity(30pcs)

7.1.2 List all test instruments and equipment used in OQ with their accuracy, precision, range,

calibration due date in the Attachment I.

7.1.2.1 Instrument Name

7.1.2.2 Model Number

7.1.2.3 Serial Number

7.1.2.4 Range

7.1.2.5 Precision

7.1.2.6 Calibration certificate No.

7.1.2.7 Calibration due date.

7.1.3 Acceptance Criteria

7.1.3.1 Each test instruments and equipment used in OQ must be within the calibration due

date and the calibration should be effective.

7.2 Operation Verification Check

7.2.1 Run the sterilization chamber and all its accessories for 4 hours under a whole sterilization

cycle, in this trail can inject compressed air into the chamber instead of EO gas. While the

sterilizer is running, assure sterilizer chamber, instruments, auxiliary equipments are turned on

and that all equipments, controls and readouts are running and functioning properly. The

followings will be checked and documented on Attachment B1~B5. In the running, if any

abnormity be found, stop the machine at once and check it.

7.2.1.1 Sterilizer Control Unit Functionality Verification. (Attachment B1)

7.2.1.2 Sterilizer Assistant Fixture Functionality Verification. (Attachment B2)

7.2.1.3 Sterilizer Alert System Functionality Verification. (Attachment B3)

7.2.1.4 Sterilizer Computer Functionality Verification. (Attachment B4)

7.2.1.5 Below functional fixture should be verified and documented in Attachment B5

7.2.1.5.1 Electric control cabinet: verify the switches, buttons, and gauges are

operational and functional properly.

7.2.1.5.2 Computer control system: verify the software, printer, and UPS are

operational and functional properly.

7.2.1.5.3 Steam generator: Verify the steam generator is operational and functional

properly and has the ability to moisturizing the air in chamber. And the steam

quality should meet the requirements.

7.2.1.5.4 Water heating system: the water heating system is operational and functional

properly and has the ability to heat the chamber.

CONFIDENTIAL –

This document contains proprietary information that may not be reproduced or disclosed without written approval.

Page 3 of 26OPERATIONAL QUALIFICATION PROTOCOL

For HZBOCON 98.6 M 3Size ETO Sterilizer (S/N: 201346)

Used to sterilize Medical Devices Products

PROTOCOL#: ZSP-14-11 Jun 4th , 2014

7.2.1.5.5 EO vaporizer: the EO vaporizer is operational and functional properly and

has the ability to heat the EO and achieve the minimum gas input

temperature (15℃).

7.2.1.5.6 ETO gas circulation system: the gas circulation fans is operational and

functional properly.

7.2.1.5.7 Chiller (include water pump): the chiller is operational and functional

properly.

7.2.1.5.8 EO exhaust, emission control and abatement systems: the system is

operational and functional properly.

7.2.1.5.9 The system software: the software is operational and functional properly

7.2.1.5.10 Nitrogen generator: the system is operational and functional properly.

7.2.1.5.11 Doors can lift by oil pump, they can be opened and closed successfully;

7.2.1.5.12 The two (2) computers can realize communication each other, any of two

can operate sterilizer successfully if close the other.

7.2.1.5.13 Air filter system: the air filter is operational and functional properly

7.2.2 Acceptance Criteria

7.2.2.1 The test results must meet the specification.

7.2.2.2 The actual response for each action must be the same as the expected.

7.2.2.3 A response of “Yes” is required for items which require a Yes / No response.

7.2.2.4 Any response of “No” must be explained in the comments section.

7.3 Vacuum speed , nitrogen injection speed, air injection speed and leakage Study

7.3.1 Conduct vacuum speed study at -30Kpa & -60Kpa & -90Kpa by following the methods defined

in Attachment C and document the result onto that form also.

7.3.2 Conduct nitrogen injection speed study by following the methods defined in Attachment C and

document the result onto that form also.

7.3.3 Conduct air injection speed study by following the methods defined in Attachment C and

document the result onto that form also.

7.3.4 Conduct vacuum leakage speed study at -90Kpa by following the methods defined in

Attachment C and document the result onto that form also.

7.3.5 Acceptance Criteria:

7.3.5.1 Vacuum speed must be above 3.5 KPa/min.

7.3.5.2 Nitrogen injection speed must be less than 8Kpa/min.

7.3.5.3 Air injection speed must be less than 8Kpa/min.

7.3.5.4 The leakage speed during six (6) hours keeping period shall be within 2KPa.

7.4 Safety and Alert Function Check

7.4.1 Equipment that detects atmospheric levels of EO or gas mixtures shall be installed near the

sterilizer and anywhere else where potential exposure could occur.

7.4.2 Each alarm device or equipment protection device shall be identified, documented and

indicated for testing in this protocol, the following positive alert shall be check and record in

Attachment B-3. The safety and alert function can be checked during trial operation.

7.4.2.1 Sensor failure alert: when the sensor of the temperature, pressure or humidity

failure, the sterilizer will give a sound and display a failure message on the screen.

7.4.2.1.1 Disconnect the temperature sensors with line, humidity sensors,

pressure sensors one by one; verify the sensor failure alert function of

the machine.

7.4.2.2 Over pressure alert: when the pressure of the chamber exceeds the setting

pressure, the sterilizer will give a sound and display an alert message on the

screen.

CONFIDENTIAL –

This document contains proprietary information that may not be reproduced or disclosed without written approval.

Page 4 of 26OPERATIONAL QUALIFICATION PROTOCOL

For HZBOCON 98.6 M 3Size ETO Sterilizer (S/N: 201346)

Used to sterilize Medical Devices Products

PROTOCOL#: ZSP-14-11 Jun 4th , 2014

CONFIDENTIAL –

This document contains proprietary information that may not be reproduced or disclosed without written approval.

Page 5 of 26

7.4.2.2.1 Set the gas joint final pressure, verify when the pressure meets the

required pressure, the over pressure alert function is OK.

7.4.2.3

Over temperature alert: when the temperature of the chamber exceeds the setting

temperature, the sterilizer will give a sound and display an alert message on the

screen.

7.4.2.3.1 Set the temperature of the chamber/water tank/vaporizer, verify the over

temperature alert function.

7.4.3 Acceptance Criteria

7.4.3.1 Each safety and alert function shall give an expected response when failure

occurs.

7.4.3.2 A response of “Yes” is required for items which require a Yes / No response.

7.4.3.3 Any response of “No” must be explained in the comments section.

7.5 Humidifing System Verification

7.5.1 Conduct verification according to attachment D and document the result also on Attachment D.

7.5.2 Acceptance Criteria: The humidity must be obviously changed after moist injection. The result

must meet the requirements of ISO11135-1.

7.6 Chamber Wall Temperature Study – 1 time

7.6.1 Set hot water temperature , open hot water circulation pump, after the water temperature keep

stable for 1 hours at least , use surface temperature meter to measure temperature of chamber

wall which place water jacket, see attachment F1 for measuring location and document the

results on F2.

7.6.2 There are forty-nine (49) water jacket distributed in chamber and five (5) water jacket distributed

in each door.

7.6.3 Acceptance Criteria

7.6.3.1 The actual temperature of all points in chamber wall should meet the requirements that

difference between maximum and minimum should be within 10℃.

7.6.3.2 Documented any problems that may have occurred during validation and all correction

of any issues that may have been completion before the operation qualification.

7.7 Temperature & Humidity Distribution Study in Empty Chamber – 3 times

7.7.1 This study is to verify and document that the temperature and humidity distribution is within the

set-up range, stable and uniform. The empty chamber statuses will be simulated.

7.7.2 Sensor Program: forty –four (44) temperature sensors and thirty (30) dual sensors shall be

used for OQ purpose.

7.7.3 Perform this study by following actions:

7.7.3.1 Time synchronize: Check the time controller of chamber and synchronize the time of

these items and the data programming computer. Times should be synchronized to

within 5 minutes.

7.7.3.2 Program all sensors to start before the intended study start time. The start time intervals

for every sensor should be within 1 minute. Recording intervals of the temperature or

dual sensors should be no more than 10 minutes.

7.7.3.3 Sensors Placement: Place the forty –four (44) temperature sensors and thirty (30) dual

sensors in the interspaces of the room evenly, the placement as per the following

diagram --- Sensor Location for Temperature / Humidity Distribution Study.OPERATIONAL QUALIFICATION PROTOCOL

For HZBOCON 98.6 M 3Size ETO Sterilizer (S/N: 201346)

Used to sterilize Medical Devices Products

PROTOCOL#: ZSP-14-11 Jun 4th , 2014

CONFIDENTIAL –

This document contains proprietary information that may not be reproduced or disclosed without written approval.

Page 6 of 26

7.7.3.4 Sterilization parameters setting: Set the sterilization parameters as SOP VS-EO019/02,

Verify all valves and controls are in the proper set positions. Once the program start time

has passed, start the operation of the chamber.

7.7.3.5 Nitrogen will be used instead of EO during EO injection stage in each cycle.

7.7.3.6 Sterilization finished: Upon completion of running, shut the chamber down. Document

the time the study ended. Remove the sensors and download the data. Assure all data

is downloaded to a backup drive.

7.7.3.7 Collect all monitoring equipment and records of the sterilizer chamber, such as data and

charts for temperature, humidity etc. the data record interval shall be within 5 minutes.

Verify that all required parameters were achieved.

7.7.4 Acceptance Criteria

7.7.4.1 The record of sterilization cycle must follow the requirement in below table.

Remarks: Due to empty chamber has low humidity, so the displayed humidity from chamber humidity sensors is not considered

during temperature and humidity distribution study.

7.7.4.2 During exposure stage, the temperature difference between monitoring location

temperature and average chamber temperature are within 3℃ .

7.7.4.3 Documented any problems that may have occurred during validation and all correction

of any issues that may have prevented completion of the operation qualification.

8 OPERATIONAL QUALIFICAITON REPORT

8.2 Operational Qualification report will be written, clearly showing how the acceptance criteria of this

protocol were met. If there were any deviations from the protocol, then the completed deviation forms

must be included in the report. The report will be reviewed and approved by Allmed.

OPERATIONAL QUALIFICATION PROTOCOL For HZBOCO 98.6 M 3Size ETO Sterilizer

Publish Time：2023-11-07