Life Sciences FDA & USP VI Seals

OES-7010-Drug-Delivery-Sealing-Solutions.pdf

 Life Sciences
FDA and USP Class VI O-Ring Materials

Innovative sealing:
Parker provides a wide range of specialty elastomers to accommodate the various critical sealing challenges presented by the life sciences industry.
Selecting a suitable material is critical to patient health. While the FDA Standard 21 CFR 177.2600 is frequently cited by medical device manufacturers, this is actually a contact food regulation. For most patient-contact applications, a material that meets US Pharmacopeia (USP) Class VI and/or ISO 10993/10 will be appropriate.
Most applications are fairly benign to elastomers. However, some applications such as implantable devices, are extremely complicated. Please contact the division for assistance in selecting materials in these situations.