Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO All rights reserved. ISO copyright office Case postale 56?
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Adobe is a trademark of Adobe Systems Incorporated. Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing.
Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
ISO All rights reserved. ISO copyright office Case postale 56? CH Geneva 20 Tel. 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 represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
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. 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 consists of the following parts, under the general title Injection containers and accessories:?
Closures made from elastomeric materials are suitable primary packaging materials for parenteral preparations. In order to provide seal 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 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 these components.
The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO are intended for single use 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. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document including any amendments applies.
Figure 1 illustrates two types of closures, Types A and B. The height of the spacers shall not exceed 0,3 mm. The tolerances of the trimming edge of the flange shall comply with the tolerances specified in Table 1 for diameter d3. The designation is expressed as the number of this part of ISO followed by the nominal size of the closure followed by the type letter. In case other sterilization methods are used, e. Closures shall be made from the elastomeric formulation originally tested and approved by the end user.
The closure manufacturer shall ensure the conformance of each delivery with the type sample and the compliance with previously agreed functional and compendial requirements. Alternatively, the hardness can be tested on the closures in accordance with ISO If the test specimen complies with 7.
The closures shall maintain their performance characteristics throughout the entire shelf-life of the medicinal product, which is tested as part of the stability test by the user. NOTE Ageing depends upon the storage and handling conditions. Guidelines for storage of vulcanized rubber are given in ISO
DIN EN ISO 8362-5:2016-07