ISO 11737 Bioburden Testing

We are capable of conducting microbial enumeration and controlled microorganisms tests on non-sterile pharmaceuticals, pharmaceutical raw materials and excipients, and biological products in accordance with the Chinese Pharmacopoeia, United States Pharmacopeia (USP), and European Pharmacopoeia under both cGMP and ISO 17025 systems. Additionally, we can perform bioburden testing on medical devices as per ISO 11737-1.

Tested Products/Categories and Corresponding Standards (Methods) Names and Numbers

Microbial Enumeration for Non-sterile Pharmaceuticals, Pharmaceutical Raw Materials and Excipients, and Biological Products

Chinese Pharmacopoeia, General Rule 1105

USP <61>

European Pharmacopoeia <2.6.12>

Controlled Microorganisms Test for Non-sterile Pharmaceuticals, Pharmaceutical Raw Materials and Excipients, and Biological Products

Chinese Pharmacopoeia, General Rule 1106

USP <62>

European Pharmacopoeia <2.6.13>

Bioburden Test for Medical Devices

ISO 11737-1

Chinese Pharmacopoeia, General Rules 1105 and 1106

USP <61> and <62>

European Pharmacopoeia <2.6.12> and <2.6.13>

Testing Standards

l Appendix XIJ Microbial Limit Test in Volume II of the Chinese Pharmacopoeia (2010 Edition)

l GB/T 19973.2-2005 Sterilization of Medical Devices - Microbiological Methods - Part 2: Sterilization of Medical Devices - Microbiological Methods - Part 1: Sterility Test for the Definition, Validation, and Maintenance of Sterilization Processes

l ISO 11737-2-2018 Sterilization of Medical Devices - Microbiological Methods - Part 1: Sterility Test for the Definition, Validation, and Maintenance of Sterilization Processes

l YY/T 1737-2020 Analytical Method for Bioburden Control Levels of Medical Devices

l GB 15980-2009 Hygiene Standard for Single-use Medical Devices

JJR Laboratory in China, based on relevant standards and different testing methods, will provide customers with suitable extraction or dissolution methods to facilitate smooth testing.

Our Advantages

l JJR Laboratory's Life Sciences Laboratory in China is registered with the U.S. Food and Drug Administration (FDA) and has passed audits conducted by the FDA and local regulatory authorities, enabling us to provide professional quality control services and ensure product quality and safety.

l JJR Laboratory holds CNAS certification for microbial limit testing projects (in accordance with both Chinese and USP standards).

Sample Types

Our sample type scope is broad, including pharmaceuticals (finished and semi-finished products), pharmaceutical raw materials and excipients, biological products, and medical devices.

Testing Methods

Our testing methods cover the two most mainstream approaches: the plate method and membrane filtration method. We also provide method suitability testing for our clients.

Service Process

Sample Submission: Communicate with our engineers, submit your testing requirements, and send us your samples.

Initial Sample Inspection: Upon receiving the samples, we will conduct an initial inspection and formulate a detailed experimental plan.

Quotation: After the initial inspection, we will provide a quotation based on the customer's testing needs and the complexity of the experiment.

Agreement and Payment: Both parties will sign a confidentiality agreement. Upon payment, we will commence the experiment.

Experiment Completion: The time required for the experiment varies based on the customer's testing needs and the complexity of the experiment.

Report Delivery and Post-service: We will mail the testing report and provide subsequent services.