{"id":41688,"date":"2024-05-29T22:39:45","date_gmt":"2024-05-29T22:39:45","guid":{"rendered":"https:\/\/www.alicat.com\/?post_type=article&p=41688"},"modified":"2026-04-09T22:46:26","modified_gmt":"2026-04-09T22:46:26","slug":"bioprozess-ausrustungszertifikate-fur-elastomerkomponenten","status":"publish","type":"support","link":"https:\/\/www.alicat.com\/de\/support\/bioprocessing-equipment-certifications-for-elastomeric-components\/","title":{"rendered":"Zertifizierungen von Bioprozessanlagen f\u00fcr Elastomerkomponenten"},"content":{"rendered":"\n[et_pb_section fb_built=”1″ _builder_version=”4.23.1″ _module_preset=”default” locked=”off” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_row _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||||false|false” custom_padding=”0px||0px||false|false” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_column type=”4_4″ _builder_version=”4.23.1″ _module_preset=”default” global_colors_info=”{}” theme_builder_area=”post_content”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” custom_margin=”||2rem||false|false” hover_enabled=”0″ global_colors_info=”{}” theme_builder_area=”post_content” sticky_enabled=”0″]

Bioprocessing Equipment Certifications for Elastomeric Components<\/h1>\nThe American Society of Mechanical Engineers (ASME)\u00a0periodically publishes standards which lead to recommendations for bioprocessing equipment certifications, with the latest edition published in 2016 (BPE\u20112016). 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.\n\nEnsuring 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.\n\n316L stainless steel is commonplace in bioprocessing and serves as the widely accepted standard material.\u00a0For elastomers, the available choices and certifications are more numerous and often less well understood.[\/et_pb_text][et_pb_image src=”https:\/\/www.alicat.com\/wp-content\/uploads\/2025\/08\/sausage_tying_machine.webp” alt=”A high speed sausage string tying machine. Alicat flow controllers have been used to increase the output per day of sausage casing extrusion equipment.” show_bottom_space=”off” _builder_version=”4.27.4″ _module_preset=”default” max_width=”80%” max_width_tablet=”80%” max_width_phone=”100%” max_width_last_edited=”on|phone” module_alignment=”center” custom_margin=”||2rem||false|false” global_colors_info=”{}” theme_builder_area=”post_content”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” global_colors_info=”{}” theme_builder_area=”post_content”]

Can you get USP Class VI compatible materials with an Alicat instrument?<\/h2>\n

Yes. Alicat\u00ae<\/sup> offers an option to build with USP Class VI materials, and will provide you a list of wetted materials to demonstrate compliance.<\/p>\n

Common certifications for elastomeric components<\/h2>\n

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.<\/p>\n

These elastomers are available with a variety of certifications:<\/p>\n

USP Class VI<\/strong> 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\u00a0biocompatibility<\/a>. 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 stringent tests for toxicity and shown to be nonreactive as implanted materials in\u00a0live animal testing.<\/p>\n

FDA approved<\/strong> or\u00a0food grade<\/strong> classifications are provided by the US Department of Agriculture or Food and Drug Administration, to indicate materials which have been shown to be non\u2011toxic and non\u2011carcinogenic. The FDA does not specifically approve these materials \u2014 rather, materials manufacturers create materials and put them through stringent testing processes to ensure they meet the stated criteria.<\/p>\n

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.<\/p>\n

NSF\/ANSI 51\u20112017\u00a0<\/strong>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.<\/p>\n

How do you get biocompatible materials in an Alicat instrument?<\/h2>\n

Manufacturers that serve these industries, which are highly regulated by the FDA, require some or all of these certifications. They maintain complete lists of wetted materials and the relevant certifications. This gives end\u2011users and OEMs full visibility into the materials used in construction and ensures regulatory compliance and the appropriate bioprocessing equipment certificates where applicable.<\/p>\n

Alicat is proud to offer stainless steel and approved elastomers in devices and OEM assemblies you need to use for these regulated processes. Ask an Alicat application engineer for the best choices of elastomers for the process you\u2019ll be running. The materials we use are chosen for their durability, corrosion resistance, and resistance to offgassing. We can provide a list of USP Class VI compatible wetted materials used in your devices, for your records.<\/p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]\n","protected":false},"featured_media":45325,"parent":0,"template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"1920","content-type":"","_searchwp_excluded":""},"categories":[171],"class_list":["post-41688","support","type-support","status-publish","has-post-thumbnail","hentry","category-food-beverage-industry"],"acf":[],"yoast_head":"\nBioprocessing Equipment Certifications for Elastomeric Components - Alicat Scientific<\/title>\n<meta name=\"description\" content=\"Can you get USP Class VI materials in an Alicat instrument to use in bioprocessing? Yes. 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