USP Class VI

Precision Polymer Engineering offers a range of USP Class VI compliant elastomer materials for use in medical sealing applications.

What is USP Class VI?

The United States Pharmacopeia (USP) is a non-government organisation promoting public health by establishing standards to ensure the quality of medicines and other health care technologies.

Whilst this organisation is concerned with the pharmaceutical and bio-technology industries, manufacturers of hygienic equipment will be designing multipurpose designs which may be used in many different industry sectors.

Standards are published in the US Pharmacopeia and the National Formulary (USP NF). Compliance to USP Class VI is often requested by end users. Testing for compliance involves an assessment of the effects of the material, and extractables, on tissue.

PPE manufactures medical and pharmaceutical grade gaskets and seals, including O-rings, sanitary gaskets and other high performance seals from a range of 15 USP Class VI compliant elastomers.

Three chapters are applicable to elastomers, plastics and polymeric materials:

Biological reactivity in vitro testing EPDM, Silicone, FKM, FFKM

Biological reactivity in vivo testing EPDM, Silicone, FKM, FFKM

Physicochemical tests – closures for injections EPDM

PPE certificate downloads for Chapter 87, 88, and 381

Biological reactivity in vitro testing EPDM, Silicone, FKM, FFKM

Biological reactivity in vivo testing EPDM, Silicone, FKM, FFKM

Physicochemical tests – closures for injections EPDM

PPE certificate downloads for Chapter 87, 88, and 381

Industries

Find out more about industries linked to USP Class VI compliant elastomers:

Pharmaceutical & Biomedical

Medical rubber seals need to demonstrate chemical resistance and mechanical strength alongside hygienic sealing capability. See how our elastomer seals meet the challenge.

Products

USP Class VI certification relates to a wide range of sealing solutions developed and manufactured by PPE, including:

HyClamp™ Mini Gaskets

PPE manufactures Hyclamp™ gaskets to DIN32676 in metric and imperial sizes, including a range of mini clamp gaskets.

BS4825 Gaskets

PPE’s range of BS4825-3 gaskets are molded in several elastomer grades, including FFKM, FKM, EPDM, and Silicone (FMQ).

DIN11851 D-Seals

PPE manufactures elastomer D-seals to fit DIN 11851 fittings, and aseptic pipe couplings including HyClamp sanitary gaskets.

DIN11864 O-Rings

Aseptic O-rings are commonly used in DIN 11866 pipe couplings in a wide range of hygienic processing applications.

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