Bioprocessing equipment certifications for elastomeric components

The American Society of Mechanical Engineers (ASME) periodically publishes standards which lead to recommendations for bioprocessing equipment certifications, with the latest edition published in 2016 (BPE-2016). These standards clearly recommend that only certain materials be used in bioprocessing to ensure that biologic and drug products are not contaminated and can be most easily cleaned and sterilized.

Ensuring that the stainless steel which meets these requirements is used for all components which come into contact with biological material is a common practice. In addition to standard material certifications, the stainless steel should include a heat trace to ensure it meets all local and regulatory requirements.

316L stainless steel is commonplace in bioprocessing and serves as the widely accepted standard material.  For elastomers, the available choices and certifications are more numerous and often less well understood.

Common certifications for elastomeric components

Acceptable elastomeric components are carefully chosen for their superior durability and corrosion resistance, as well as their resistance to offgassing. Recommended and common elastomers include ethylene propylene diene (EPDM), fluoroelastomer (FKM), and perfluoroelastomer (FFKM). Each of these materials meets all necessary requirements for bioprocessing.

These elastomers are available with a variety of certifications:

USP Class VI certification indicates that the elastomer has very low bioreactivity, and is common for materials that are used clinically and/or require a high degree of biocompatibility. Elastomers that are used in conjunction with process fluids, or which are likely to come into contact with process fluids, are recommended to carry a USP Class VI classification. USP Class VI materials have passed pass stringent tests for toxicity and shown to be nonreactive as implanted materials in live animal testing.

FDA approved or food grade classifications are provided by the US Department of Agriculture or Food and Drug Administration, to indicate materials which have been shown to be non-toxic and non-carcinogenic. The FDA does not specifically approve these materials – rather, materials manufacturers create materials and put them through stringent testing processes to ensure they meet the stated criteria.

Many materials used in bioprocessing will carry either an FDA or a USP Class VI classification, with manufacturers and suppliers providing certification that their materials conform to FDA 21 CFR Part 177 and/or USP Class VI. Again, these certifications are particularly important for equipment which comes into direct contact with intermediary or final biological drug products.

NSF/ANSI 51-2017 standards are primarily used for products in the food and beverage industries for components and finished goods used in commercial food preparation. It is less frequently seen in bioprocessing.

Manufacturers that serve these industries which are highly regulated by the FDA and require some or all of these certifications maintain complete lists of wetted materials and the relevant certifications. This gives end-users and OEMs full visibility into the materials used in construction and ensures regulatory compliance and the appropriate bioprocessing equipment certificates where applicable.