This guide applies to the determination of the safety of non-metallic materials used in contact with biotechnology product containing solutions. Process materials leach low level of residues into water, cell culture media, buffers, and other product containing solutions. This document offers guidance on determining the safety of these materials (process materials) for use. The goal is to prevent toxic extractables from entering process streams and ultimately contaminating the final product in unacceptable levels.

The purpose of this guide is to describe tests to qualify materials with respect to any extractable substances so as to prevent unintentional introduction of a potential source of objectionable substances. An extractable material is objectionable if it is toxic, interacts with product constituents, interferes with required assays, or otherwise affects the process stream so as to adversely affect critical quality parameters, for example, purity, safety, efficacy, identity, strength of the final product or its successful production. All organizations producing pharmaceutical products should consider the points in this guide when qualifying process materials for use in their production processes.

This guide outlines the application of the process material tests primarily in ASTM or USP. Typical process materials include high molecular weight polymers and solids such as hoses, filters, filter housings, containers, valve diaphragms, gaskets, o-rings, chromatography resins, and chromatographic columns.

The battery of tests described in this guide is intended to cover a wide variety of potential attributes of materials and to characterize possible extractables.

The material specification will vary depending on the impact on the final product and the point in the process that the product solution contacts the material. Tighter specifications should be considered for extractables for final product purification process materials than for fermentation media process materials.

1.1 This guide covers procedures and test methods for process component qualification by the end user. The goal is to assess the safety impact of extractables from non-metallic process components used in contact with bioprocessing solutions. This encompasses the impact of extractables on the safety of the final product as it passes through the various stages of the manufacturing process. This guide is not designed for evaluation of metallic materials, final product container/closures or those components intentionally added to the product or production streams during the manufacturing process. Testing of solids and extracts is specified in other ASTM standards. Materials must be qualified by specific use.

1.2 The values stated in SI units are to be regarded as the standard.

1.3 There is no companion guide available.

1.4 Safety/Fire hazards: Extractions with organic solvents will be infrequent under this Guide, but, when used must be treated as potential fire/explosion hazards.

1.5 This guide 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.