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  • ISO 8362-5:2016

    Current The latest, up-to-date edition.

    Injection containers and accessories Part 5: Freeze drying closures for injection vials

    Available format(s):  Hardcopy, PDF, PDF 3 Users, PDF 5 Users, PDF 9 Users

    Language(s):  French, English

    Published date:  15-02-2016

    Publisher:  International Organization for Standardization

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    Abstract - (Show below) - (Hide below)

    ISO 8362-5:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 83621 and ISO 83624, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.

    The dimensional requirements are not applicable to barrier-coated closures.

    Closures specified in this part of ISO 8362 are intended for single use only.

    NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be strongly affected by the nature and performance of the primary packaging.

    General Product Information - (Show below) - (Hide below)

    Development Note Supersede ISO/DIS 8362-5. (02/2016)
    Document Type Standard
    Publisher International Organization for Standardization
    Status Current
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ISO 11040-5:2012 Prefilled syringes — Part 5: Plunger stoppers for injectables
    00/560909 DC : DRAFT MAR 2000 BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    BS ISO 11040-5:2012 Prefilled syringes Plunger stoppers for injectables
    UNI EN ISO 8871-2 : 2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION
    BS EN ISO 7864:2016 Sterile hypodermic needles for single use. Requirements and test methods
    BS EN ISO 8871-1:2004 Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates
    I.S. EN ISO 7864:2016 STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
    DIN ISO 11040-5:2013-12 PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
    DIN EN ISO 8871-2:2014-08 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005)
    EN ISO 8871-2:2004/A1:2014 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003/AMD 1:2005)
    I.S. EN ISO 8871-2:2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003)
    BS 7652-2:1995 Prefilled syringes Specification for plungers and discs for dental local anaesthetic cartridges
    DIN ISO 11040-5 E : 2013 PREFILLED SYRINGES - PART 5: PLUNGER STOPPERS FOR INJECTABLES (ISO 11040-5:2012)
    ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
    ISO 8871-2:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization
    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
    UNE-EN ISO 7864:2017 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
    EN ISO 8871-1 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 1: EXTRACTABLES IN AQUEOUS AUTOCLAVATES
    BS EN ISO 8871-2 : 2004 ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
    ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
    ISO 2230:2002 Rubber products — Guidelines for storage
    ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
    ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
    ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
    ISO 554:1976 Standard atmospheres for conditioning and/or testing — Specifications
    ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
    ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
    ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
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