Sterilizing Process Validation

07 Extractables and leachables analysis Ensuring product safety Parker meets strict industry guidelines for ensuring toxicity, animal derived materials and bio-compatibility of our products An extractable is a chemical removed from the material by an artificial or exaggerated force for example solvent, temperature or time. Parker can provide extractables studies for representative filters, following the draft of USP <665>. An independent toxicology study can be made to determine risk in your product. A leachable migrates from the contact surface into the process fluid during normal use. Parker can organize leachables testing in your product, following the draft of USP <665> or BPOG methodology. Impurities It is a regulatory expectation that filter users investigate, minimize and remove (where possible) the level of extractables (soluble material) within the manufacturing process.

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