This part of ISO 8362 specifies the shape, dimensions, materials, performance requirements and marking for a type of stopper for injection bottles in accordance with ISO 8362-1 and ISO 8362-4, used in connection with the freeze-drying (or lyophilization) of medicinal products and biological preparations . The dimensional requirements do not apply to coated plugs. The plugs described in this part of ISO 8362 are for single use only. NOTE The effectiveness, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the type and design of the primary packaging.
EN ISO 8362-5:2016 Referenced Document
ISO 15378:2015 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
ISO 2230:2002 Rubber products - Guidelines for storage
ISO 3302-1:2014 Rubber - Tolerances for products - Part 1: Dimensional tolerances
ISO 3302-2:2008 Rubber - Tolerances for products - Part 2: Geometrical tolerances
ISO 48:2010 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 554:1976 Standard atmospheres for conditioning and/or testing; Specifications
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)
ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
ISO 8871-5:2005 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
EN ISO 8362-5:2016 history
2016EN ISO 8362-5:2016 Injection containers and accessories - Part 5: Freeze drying closures for injection vials (ISO 8362-5:2016)