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Micro Sterility Testing Terms

Sterility testing services may be performed using different testing approaches, including (i) a rapid sterility method test service; and (ii) a standard sterility method test service aligned with conventional fourteen (14) day incubation. Each approach has distinct performance characteristics, validation scope, and limitations.  Customer hereby acknowledges and agrees to the following:

  • Sterility testing performed using the BD BACTEC® system is subject to method validation limitations. Validation conducted by the testing laboratory demonstrated performance comparable to compendial sterility testing under validated conditions, including detection of specified challenge organisms such as Cutibacterium acnes at fourteen (14) days.
  • Sterility testing performed under shortened incubation timelines may exhibit performance characteristics that differ from conventional compendial methods, including potential differences in detection sensitivity and time to detection. Additional challenge organisms, including low level or slow growing microorganisms, may be required to support evaluation of accelerated detection strategies.
  • Certain organisms, including Penicillium chrysogenum and Cutibacterium acnes, did not demonstrate equivalent detection performance under rapid conditions. Accordingly, such validation establishes the conditions under which the BD BACTEC® method is suitable for use and informs the sterility testing approaches that may be applied.
  • Test Method Suitability Studies (“TMSS”) are required to evaluate the suitability of the sterility testing method for Customer’s specific product under the proposed testing conditions. The results of the applicable TMSS shall determine the sterility testing method and incubation conditions that may be used for Customer’s product in GMP testing. 
  • Sterility testing conditions that are not supported by TMSS results shall not be deemed validated, suitable, or permitted under this Agreement.

Customer is solely responsible for selecting the appropriate testing approach and determining its suitability for Customer’s product, process, and regulatory requirements. By electing Rapid Sterility Testing, Customer acknowledges and accepts the additional risks associated with accelerated sterility testing, including potential differences in detection sensitivity or timing. 

Customer is solely responsible for selecting the appropriate testing approach and determining its suitability for Customer’s product, process, and regulatory requirements. Customer acknowledges and accepts the additional risks associated with accelerated sterility testing, including potential differences in detection sensitivity or timing.

Any changes to the study protocol, including amendments or deviations, must be documented, justified and approved in writing by QualTex and the Client (or authorized Client representative) and will be signed and dated and maintained with the study records. QualTex will document and investigate deviations in accordance with applicable quality system requirements.

QualTex does not guarantee that the study will meet the Client’s expectations or that the Samples will pass any test criteria. All Testing is performed in accordance with applicable standards but is inherently subject to biological and technical variability. 

If any portion of the Study must be repeated solely due to QualTex’s failure: (i) of controls, (ii) to adhere to the approved protocol; or (iii) to meet agreed responsibilities, then QualTex will repeat the affected portion of the study at no additional cost to Client. If: (i) one or more Samples fail the study, or (ii) Client requests repeat testing, confirmation testing, or modified testing not caused by QualTex error; or (iii) the study required modification, additional method development, or troubleshooting due to sample interference, complexity, or product-specific effects (including TMSS-related issues, then such work will be performed only upon approval and at additional cost, as quoted by QualTex. 

The Client as applicable, shall review the study protocol and final report and notify QualTex of any potential deficiencies. QualTex will make reasonable corrections that do not alter any technical data. As between QualTex and the Client, the Client retains sole responsibility and liability for: (i) compliance with specific regulatory requirements applicable to the Client, the protocol, the test article and final report; and (ii) the interpretation and use of results.

Unless otherwise agreed in writing, all unused or residual Samples may be destroyed following completion of the study in accordance with QualTex’s standard operating procedures and applicable safety and regulatory requirements.