Significance and Use
The preservation of TEMPs can affect their subsequent characteristics (for example, structural, mechanical, biological, and metabolic properties). The aspects of preservation that can most adversely affect these characteristics include, but are not limited to, cooling, cooling rates, warming, warming rates, freezing, freezing rates, thawing, thawing rates, preservation medium, and pre- and post-processing.
The intent of this guide is to outline procedures that can minimize the loss or degradation of the desired characteristics of the TEMPs.
Scope
1.1 This guide covers the development of standards related to the preservation of cells, tissues, and tissue engineered medical products (TEMPs). Preservation techniques include freezing, vitrification, and hypothermic preservation. This guide discusses preservation, including issues of pre-preservation processing, the process of preservation, storage, transport, recovery, post-preservation processing, quality assurance, and process control.
1.2 This guide contains general guidelines for the preservation of cells, tissues, and tissue engineered medical products (TEMPs) and will identify more specific parameters relevant to the preservation of TEMPs.
1.3 This guide does not apply to any medical products of human origin regulated by the U.S. Food and Drug Administration (FDA) under 21 CFR Parts 16 and 1270 and 21 CFR Parts 207, 807, and 1271.
1.4 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 requirements prior to use.