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

June 17, 2022

Dear Customer: Hello:

Thank you and your team for your long-term support for Jinnan Medical Testing business!

After 7 years of accumulation and development, in order to better serve customers, the company has officially changed from the first-party laboratory of "Jinpai Medical Company Internal Laboratory" to the third-party testing organization "Shenzhen Jinnan Medical Testing Technology Co., Ltd. ", and obtained the CNAS accreditation certificate and CMA qualification certificate; the scope of testing capabilities mainly involves medical device microbiology and chemical testing, clean room (area) testing, sterile barrier system testing, package transportation testing, purified water testing, etc.

Jinnan Medical Testing Laboratory has always been adhering to the quality policy of "behavioral justice, scientific methods, accurate data, and standardized services" and the core values ​​of "integrity and pragmatism to win the full trust of customers; professionalism and efficiency to create long-term value for customers" , in order to give back to customers’ trust in Jinnan Laboratory; and in order to better support customers to carry out work more smoothly in the daily inspection business submission, Jinnan Company intends to confirm the bioburden and non-toxicity of products in the process of ethylene oxide sterilization Bacteria testing and domestic and foreign standards are shared with the company's technical research and development and inspection personnel. An online sharing session will be held in June 2022. We sincerely invite you to participate!

The specific meeting schedule is as follows:

1. Conference organization

Shenzhen Jinnan Medical Testing Technology Co., Ltd.

Shenzhen Jinpai Medical Packaging Sterilization Service Co., Ltd.

2. Meeting time

June 17, 2022 14:00-16:30

3. Meeting method

live online

4. Contents of the meeting

1. Analysis of differences in the selection of bioburden testing standards before domestic and foreign registration and sterilization confirmation of medical devices (ISO11737.1-2018, GB/T19973.1-2015, Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, etc.);

2. According to ISO11737.1-2018 and GB/T19973.1-2015, the bioburden test requirements and methods of medical device products are introduced;

3. Selection and difference analysis of product sterility test standards in the sterilization confirmation process of medical devices (ISO11737.2-2019, GB/T19973.2-2018, Chinese Pharmacopoeia, US Pharmacopoeia, European Pharmacopoeia, etc.);

4. According to ISO11737.2-2019 and GB/T19973.2-2018, the requirements and methods for sterility testing of medical device products are introduced.

5. Conference explainers

Zhang Lan Master of Microbiology

Engaged in medical device related testing and laboratory management for many years;

Proficient in microbial testing, chemical testing and clean room testing related to sterile medical devices;

Proficient in all international and domestic standards related to testing, such as GB, ISO, CP, USP, EP, etc.;

Currently serving as the laboratory manager of Shenzhen Jinnan Medical Testing Technology Co., Ltd. and the authorized signatory of CNAS, CMA microbiology, chemistry, packaging and other testing fields.

6. Participants

Enterprise technology research and development personnel, inspection personnel.

7. Contact registration method

1. Training contact: Mr. Zheng/Jinnan Testing Marketing Department

2. Registration phone number: 19129490661/13923648758 (same number on WeChat)

3. Registration email: ks09@kingservice-ps.com

4. Registration method: