Reference number ISO 8362-2:2008(E)© ISO 2008
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INTERNATIONAL STANDARD ISO 8362-2Second edition 2008-10-15Injection containers and accessories — Part 2: Closures for injection vials Récipients et accessoires pour produits injectables — Partie 2: Bouchons pour flacons Copyright International Organization for Standardization
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ISO 8362-2:2008(E) © ISO 2008 – All rights rerved iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be reprented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates cloly with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 8362-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical u .
This cond edition cancels and replaces the first edition (ISO 8362-2:1988) which has been technically revid in order to align this part with ISO 8871-1, ISO 8871-4 and ISO 8871-5.
ISO 8362 consists of the following parts, under the general title Injection containers and accessories : ⎯ Part 1: Injection vials made of glass tubing
⎯ Part 2: Closures for injection vials
⎯ Part 3: Aluminium caps for injection vials
⎯ Part 4: Injection vials made of moulded glass
⎯ Part 5: Freeze drying closures for injection vials
⎯ Part 6: Caps made of aluminium-plastics combinations for injection vials
⎯ Part 7: Injection caps made of aluminium-plastics combinations without overlapping plastics part
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ISO 8362-2:2008(E) iv © ISO 2008 – All rights rerved
Introduction
The purpo of this part of ISO 8362 is to specify the shape and dimensions of, and the requirements for, elastomeric closures intended for pharmaceutical u. Closures made from elastomeric materials are suitable primary packaging materials for parenteral preparations. In order to provide al integrity of the container closure systems the dimensions of the elastomeric closures have to be compatible with the dimensions of the glass vials and the caps as specified in corresponding parts of ISO 8362.
Primary packaging components made of elastomeric materials are an integral part of medicinal products and thus the principles of current Good Manufacturing Practices (cGMP) apply to the manufacturing of the components.
Principles of cGMP are described in, for example, ISO 15378 or GMP Guidelines as published by the European Community and the United States of America.
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INTERNATIONAL STANDARD ISO 8362-2:2008(E)
© ISO 2008 – All rights rerved 1Injection containers and accessories —
歌曲一生无悔Part 2:
Closures for injection vials
读书万卷
1 Scope
This part of ISO 8362 specifies the shape, dimensions, material, performance requirements and labelling of closures for injection vials covered by ISO 8362-1 and ISO 8362-4.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this part of ISO 8362 are intended for single u only.
NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.
早上好的句子短语2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
干花插花ISO 48, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD)
救助申请书ISO 3302-1, Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 3302-2, Rubber — Tolerances for products — Part 2: Geometrical tolerances
ISO 7619-1, Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore hardness)
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical u — Part 1: Extractables in aqueous autoclavates
ISO 8871-4, Elastomeric parts for parenterals and for devices for pharmaceutical u — Part 4: Biological requirements and test methods
ISO 8871-5:2005, Elastomeric parts for parenterals and for devices for pharmaceutical u — Part 5: Functional requirements and testing
3 Classification
Closures for injection vials shall be classified as follows:
五行属水的吉祥字
⎯ Type A: closures for injection vials without no-pop/blow-back feature.
⎯ Type B: closures for injection vials with no-pop/blow-back feature.
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