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Explanation of domestic and international standards for product bioburden and sterility testing during sterilization confirmation process | Online training

Explanation of domestic and international standards for product bioburden and sterility testing during sterilization confirmation process | Online training

  • Time of issue:2022-05-21
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Explanation of domestic and international standards for product bioburden and sterility testing during sterilization confirmation process | Online training

Dear customer
Thank you and your team for their long-term support of Jinnan Medical Testing business!
After 7 years of accumulation and development, in order to better serve customers, the company has officially transformed from the first party laboratory of "Jinpai Medical Company Internal Laboratory" to a third-party testing institution "Shenzhen Jinnan Medical Testing Technology Co., Ltd.", and has obtained CNAS recognition certificate and CMA qualification recognition certificate; The scope of testing capabilities mainly involves microbiological and chemical testing of medical devices, clean room (area) testing, sterile barrier system testing, packaging transportation testing, purified water testing, etc.
Jinnan Medical Testing Laboratory has always adhered to the quality policy of "fair behavior, scientific methods, accurate data, and standardized service" and the core values of "integrity, pragmatism, winning the full trust of customers; professionalism, efficiency, and creating long-term value for customers", in order to repay customers' trust in Jinnan Laboratory; In order to better support customers in carrying out their daily testing business more smoothly, Jinnan Company plans to share the product bioburden and sterility testing domestic and foreign standard explanations of the ethylene oxide sterilization confirmation process with the company's technical research and inspection personnel. We will hold an online sharing meeting in June 2022 and sincerely invite you to participate!
The specific meeting arrangements are as follows:
1、 Conference organization
Shenzhen Jinnan Medical Testing Technology Co., Ltd
Shenzhen Jinpai Medical Packaging and Sterilization Service Co., Ltd
2、 Meeting time
June 17, 2022 14:00-16:30
3、 Meeting format
Online live streaming
4、 Meeting content
1. Analysis of differences in the selection of bioburden testing standards for medical devices before registration and sterilization confirmation at home and abroad (ISO11737.1-2018, GB/T19973.1-2015, Chinese Pharmacopoeia, American Pharmacopoeia, European Pharmacopoeia, etc.);
2. Introduction to the requirements and methods for bioburden testing of medical device products in accordance with ISO11737.1-2018 and GB/T19973.1-2015;
3. Selection and Difference Analysis of Product Sterility Testing Standards for Medical Device Sterilization Confirmation Process (ISO11737.2-2019, GB/T19973.2-2018, Chinese Pharmacopoeia, American Pharmacopoeia, European Pharmacopoeia, etc.);
4. Introduction to the requirements and methods for sterility testing of medical device products in accordance with ISO11737.2-2019 and GB/T19973.2-2018.

5、 Conference presenters
Zhang Lan, Master of Microbiology
Engaged in inspection and laboratory management related to medical devices for many years;
Proficient in microbial testing, chemical testing, and cleanroom testing related to sterile medical devices;
Proficient in all international and domestic standards related to testing, such as GB, ISO, CP, USP, EP, etc;
I am currently serving as the laboratory manager and authorized signatory for all testing fields such as CNAS, CMA microbiology, chemistry, and packaging at Shenzhen Jinnan Medical Testing Technology Co., Ltd.
6、 Attendees
Enterprise technical research and development personnel, inspection personnel.
7、 Contact registration method
1. Training contact person: Mr. Zheng/Jinnan Testing and Marketing Department
2. Registration phone number: 19129490661/13923648758 (same WeChat account)
3. Registration email: ks09@kingservice-ps.com
4. Registration method:

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