BS EN ISO 8362-2:2010 Injection containers and accessories. Closures for injection vials
The purpose of this part of BS EN ISO 8362 is to specify the shape and dimensions of, and the requirements for, elastomeric closures intended for pharmaceutical use. 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 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 these 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.
BS EN ISO 8362-2 was drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights.
ISO 8362-2 was prepared by Technical Committee ISO/TC 76, Transfusion, infusion and injection equipment for medical and pharmaceutical use.
BS EN 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
Part 2 of BS EN 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.
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.
