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What documents should QA ask for before approving a product contact seal?

Start with the actual part and its intended use, not a generic certificate pack. QA needs to know the seal drawing or part number, the exact elastomer compound, its supplier, and how the delivered batch links to those records. The product contact surfaces and any seal support fluid also need to be understood.

Ask for the declarations the application actually requires. That may include evidence for USP Class VI, a relevant food contact rule, and site specific material or extractables requirements. A statement for “EPDM” or “FFKM” in general is not enough to identify the compound in the delivered seal. Record the product, CIP chemicals, SIP temperature, pressure and exposure time used in the selection. Check whether a compound or supplier substitution requires change control before the next purchase.

No certificate proves every part of seal suitability. The material evidence, batch traceability, hygienic design, and operating duty need to agree. I can help engineering and QA put those pieces together before a part is approved or changed.

Andrew Sykes | Acumen Seals & Pumps Limited | Independent mechanical seals and sealing specialist

Need a second opinion on a seal?

Call Andrew on 07767 842601 or email office@acumenseals.co.uk.