Testing on elastomeric closures is done to determine the sterility of sterile product packaging. As directed by the USP and EP, elastomeric closures are made of materials obtained by vulcanization (cross-linking) polymerization, poly-addition or poly-condensation of macromolecular organic substances (elastomers). Closure formulations contain natural or synthetic elastomers and inorganic and organic additives to aid or control vulcanization, impart physical and chemical properties or color or stabilize the closure formulation. The testing as outlined applies to closures formulated with natural or synthetic elastomeric substances. Under specific EP test procedures, closures made from silicone elastomer require a separate and distinct test regimen. The tests may be performed on uncoated or non-laminated closures of the same elastomeric compound. The functionality tests apply to and are to be performed using the entire laminated or coated elastomeric closure. Biological tests apply to both the lamination or coating material and to the base elastomer. Biological tests may be performed on the coating separately from the base elastomer, or on the coated closure itself. For all the tests, we document the closure being tested — including a full description of the elastomer, and any lubrication, coating, laminations or treatments applied — and we ensure you meet appropriate test limits for Type I and Type II elastomeric closures. USP/NF Section <381> Elastomeric Closures EP 3.2.9 Rubber Closures (Elastomeric) EP 3.1.9 Silicone Elastomer – specific to closures made from siliconeUSP 381: Elastomeric Closures - Extraction - Total Extractables, Heavy Metals, Reducing Agents, pH Change. USP 381: Elastomeric Closures , Absorbance , Acidity or Alkalinity , Ammonium , Extraction - Drug Vehicle - IPA - Purified Water , Determination of Color , Extractable Zinc , Fragmentation , Heavy Metals , Identity Test , Opalescence , Penetrability , pH Change , Reducing Substances , Self-Sealing Capacity , Total Extractables , Turbidity , Volatile Sulfides.
ABOUT THE PAGE