New Guide for Sampling Methods of Tissue Engineered Medical Products for Microbiological Safety Testing
1. Scope
1.1 This guide covers general guidelines for sampling methods for subsequent sterility assurance testing in biological scaffold, cell scaffold, and related tissue engineered medical products (TEMPs). 1.2 This guide includes a description and rationale for the various sampling methods and conditions for sterility assurance testing. Specific rationales for sampling of final container material for sterility assurance are generally discussed. The user should refer to specific sterility assurance test methods for additional details. 1.3 This guide attempts to discuss the most commonly used sampling methods associated with scaffold-based TEMPs. 1.4 The values are stated in SI units. No other units of measurement are included in this standard. 1.5. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywords
TEMPs; sterility; sampling
Rationale
Implantation into a patient requires sterility assurance of TEMPs. However, sampling methods for liquid based products are not sufficient to obtain a representative sample to provide sterility information for TEMPs. The proposed standard would provide general guidelines for sampling methods as a means to help establish quality control and sterility assurance for TEMPs.
