BS EN ISO 8362-2:2015 pdf free.Injection containers and accessories Part 2: Closures for injection vials.
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 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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 48, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 3302-I, 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 8362-1, Injection containers and accessories — Part .1: Injection vials made of glass tubing ISO 8362-4, Injection containers and accessories — Part 4: Injection vials made of moulded glass
ISO 8871-1, Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Ext ractables in aqueous autoclavates
ISO 8871-4, 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
3 Classification
Closures for injection vials shall be classified as follows:
— Type A: closures for injection vials without no-pop/blow-back feature;
— Type B: closures for injection vials with no-pop/blow-hack feature.
4 Shape and dimensions
4.1 The shape and dimensions of closures shall be as shown in Flgure 1 and as given in Table 1 Flgure 1 ilustrates two types of dosures, Types A and B.
4.2 If not otherwise specified, general dimensional tolerances shall be in accordance with ISO 3302-1 and ISO 3302-2.
4.3 If spacers are located on top of the flange, they shall not interfere with the marks for the piercing area (see Figure 1). The height of the spacers shall not exceed 0,3 mm.
NOTE The spacers in Figure 1 for Type A and T’pe B closures are shown for illustrative purposes only and do not form part of the requirements of this part of ISO 8362.
4.4 If the flange of the closure has a slightly conical shape, it shall be 0,3 mm maximum in relation to the diameter in order to facilitate production. The tolerances of the trimming edge of the flange shall comply with the tolerances specified in Table 1 for diameter, d3.
4.5 All edges of the closure may be rounded.
5 Designation
Closures can be designated according to their type (see 41 and Figure 1). The designation is expressed as the number of this part of ISO 8362 followed by the nominal size of the closure followed by the type letter.
EXAMPLE A Type A closure for injection vials of nominal size 13 complying with the requirements laid down in this part of ISO 8362 is designated as follows:
Injection closure ISO 8362-2 – 13 – A
6 Material
The elastomeric material used shall meet the requirements specified in Clause 7.
The elastomeric material shall withstand two sterilization cycles when autoclaving in saturated steam at (121 ± 2) °C for 30 mm without exceeding the specified limits and without impairment of its performance characteristics under the conditions of normal use. In case other sterilization methods are used, e.g. irradiation, the suitability of the material shall be evaluated.
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.BS EN ISO 8362-2 pdf free download.