FOLLOWUS
Zhejiang Hospital of Integrated Traditional Chinese and Western Medicine, Hangzhou, Zhejiang 310003, China
GU Jinghua, Email: agu616@163.com
ZHANG Jiying at 58055033@qq.com
Published:15 June 2025
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Gu Jinghua,Zhang Jiying.Application Analysis on Physical Parameter Monitoring in Pre-Vacuum Pressure Steam Sterilizer Using a Temperature-Pressure Measurement Device[J].Sterile Supply,2025,04(01):15-20.
Gu Jinghua,Zhang Jiying.Application Analysis on Physical Parameter Monitoring in Pre-Vacuum Pressure Steam Sterilizer Using a Temperature-Pressure Measurement Device[J].Sterile Supply,2025,04(01):15-20. DOI: 10.11910/j.issn.2791-2043.2025.1.02.
Objective
2
This study aims to explore the application of a temperature-pressure measurement device for real-time monitoring of physical parameters in pre-vacuum steam sterilizers by analyzing critical parameters and evaluating sterilizer performance
thereby ensuring sterilization effectiveness and providing a scientific basis for the physical monitoring practice of sterilizers.
Methods
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Using calibrated temperature-pressure detectors and 7 kg simulated test packs
real-time monitoring of physical parameters for three pre-vacuum steam sterilizers was conducted every two months under both full-load and partial-load conditions from January 2024 to March 2025. Parameters recorded included mean sterilization temperature
maximum and minimum sterilization temperatures
temperature uniformity
sterilization time
equilibrium time
sterilization hold time
and sterilization pressure. These were compared against preset sterilization parameter standards
and the causes of data deviations were analyzed.
Results
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A total of 50 monitoring and re-testing sessions were conducted on the three sterilizers
of which 20 sessions were under partial load (14 qualified; qualification rate of 70%) and 30 were under full load (28 qualified; qualification rate of 93.33%)
resulting in an overall qualification rate of 84%. Among the eight unqualified sessions
one session had a temperature exceeding 137℃
one session had a temperature below 134℃
eight sessions had an equilibrium time exceeding 30 seconds
and four sessions had temperature uniformity >2℃.
Conclusion
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The temperature-pressure measurement device can detect physical parameters of pre-vacuum steam sterilizers. Deviations in the sterilization process can be promptly identified and corrected through real-time monitoring and recording of critical parameters
ensuring that sterilization effectiveness meets standards. Differences were observed compared to the standard 4 kg test pack. It is recommended to incorporate this device into the routine sterilizer monitoring system to strengthen medical safety.
ZHENG S W , JIANG D , LIU P , et al . Management quality of surgical instrument and influence of cleaning and sterilization on the surgical outcomes of the patient: a review [J ] . Altern Ther Health Med , 2023 , 29 ( 8 ): 863 - 869 .
Association for the advancement of medical instrumentation . ANSI/AAMI ST79: 2010/A 4 : 2013 . Comprehensive guide to steam sterilization and sterility Assurance in Health Care facilities [S ] . 2017.
National Health and Family Planning Commission of the People’s Republic of China . Central sterile supply department (CSSD) Part Ⅲ: surveillance standard for cleaning, disinfection and sterilization ( WS310.3—2016 ) [S ] . 2016 .
Zhang Q , Qian L M . Guideline for Management and Technology of Central Sterile Supply Department [M ] . Beijing : People’s Health Press , 2023 .
British Standards Institute . BS EN ISO 17665— 1 : 2006 . Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices [S ] . 2006.
State Administration for Market Regulation , Standardization Administration of the People’s Republic of China . Technical requirements for large steam sterilizers ( GB 8599—2023 ) [S ] . Beijing : Standards Press of China , 2023 .
QIN H J . Analysis and new research progress of sterilization monitoring in disinfection supply center [J/OL ] . J Cardiovasc Surg Electron Ed , 2019 , 8 ( 1 ): 186 - 189 .
ZHAO P , WANG X , TIAN Y . Present situation analysis and progress of sterilization monitoring methods in disinfection supply center [J ] . J Qilu Nurs , 2017 , 23 ( 16 ): 64 - 66 .
GU J H , ZHANG J Y , LU L X , et al . Application of high temperature and high pressure recorder in monitoring of vacuum pressure steam sterilizer [J ] . Chin J Nosocomiology , 2016 , 26 ( 21 ): 5022 - 5024 .
WANG X , ZHANG J , ZHANG Q , et al . The temperature and pressure detector is used to detect and analyze the pressure steam sterilization program [J ] . Chin J Disinfect , 2018 , 35 ( 8 ): 614 - 615 .
ZHANG W , YAN P Q , CHEN N N , et al . Research on physical parameters detection of pre-vacuum pressure steam sterilizer [J ] . China Med Equip , 2022 , 19 ( 9 ): 157 - 161 .
ZHOU J , GUO W , SHE X W , et al . Evaluation of performance of pressure steam sterilizer by lumen sterilization process challenge device with different penetration difficulties [J ] . Chin J Nosocomiology , 2020 , 30 ( 4 ): 610 - 614 .
CHEN Y Z . Pharmaceutical Equipment and Process Design [M ] . Chemical Industry Press , 2022 , 04 .
ZHOU S T , SHI J H , LI B , et al . Validation on sterilization parameters of external surgical instrument packs and analysis on sterilization practices [J ] . Chin J Disinfect , 2023 , 40 ( 9 ): 667 - 670, 675 .
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