ISO/TC 76/WG 4 - Elastomeric parts and components and related secondary packaging components

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.

This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.

ISO 13926-2:2017 specifies the material, performance requirements and labelling and gives recommendations for shape and dimensions of plunger stoppers for pen-injectors for medical use. 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.

ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that 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 document are intended for single use only.

ISO 8871-5:2016 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536‑2 and in ISO 8536‑6.

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 8362‑1 and ISO 8362‑4, 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.

ISO 8362-2:2015 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 ISO 8362-2:2015 are intended for single use only.

ISO 11418-5:2015 specifies the design, dimensions, material, and requirements of dropper assemblies consisting of a screw cap, dropper bulbs, and pipettes for the application and dosage of liquid pharmaceutical preparations. This part of ISO 11418 is applicable to dropper assemblies used in the medical field in order to deliver pharmaceutical preparations contained in screw neck bottles according to ISO 11418-1. Dropper assemblies are applicable to primary packs used in direct contact with the drug. NOTE The potency, purity, stability, and safety of a drug during its manufacture and storage can be strongly affected by the nature and performance of the primary pack.

ISO 11040-3:2012 specifies the shape, dimensions, material, performance requirements and labelling of seals for dental local anaesthetic cartridges intended for single use only.

ISO 11040-2:2011 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for dental local anaesthetic cartridges intended for single use only.

ISO 8362‑6:2010 specifies caps made of aluminium-plastics combinations for injection vials as specified in ISO 8362‑1 and ISO 8362‑4.

ISO 8536‑2:2010 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in ISO 8536‑2:2010 are intended for single use only.

ISO 8536-3:2009 specifies aluminium caps for infusion glass bottles which are in accordance with ISO 8536-1.

ISO 10985:2009 specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4. The purpose of ISO 10985:2009 is to specify caps that provide: guarantee of originality of the closure up to the point of administration; compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or injection bottles; protection of the sealing element against soiling and mechanical damage; simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap.

ISO 8536-7:2009 specifies caps made of aluminium-plastics combinations intended for use on infusion glass bottles which are in accordance with ISO 8536-1.

ISO 8871-4:2006 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i.e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.

ISO 8362-7:2006 specifies aluminium-plastics combinations for the injection caps of injection vials, as specified in ISO 8362-1 and ISO 8362-4, where the plastics part does not overlap the diameter of the vial body.

ISO 15759:2005 specifies the dimensional and functional requirements for plastics caps with inserted elastomeric liners, attached to the infusion container [blow-fill-seal (BFS) container] by welding or by collar technique. These caps are intended for use in the packaging and handling of liquid drugs for parenteral delivery.

ISO 8871-1:2003 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use. It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements. Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time. Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.

Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. ISO 8871-3:2003 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.

ISO 8872:2003 specifies general requirements and test methods for aluminium caps for injection vials, and for infusion and transfusion bottles.

This part of ISO 8362 specifies aluminium caps for injection vials as described in ISO 8362-1 and ISO 8362-4.

ISO 13926-2:2011 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for pen-injectors for medical use.

ISO 8536-6:2009 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, which are 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 ISO 8536-6:2009 are intended for single use only.

ISO 8362-5:2008 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials. Closures specified in ISO 8362-5:2008 are intended for single use only.

ISO 8362-2:2008 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 ISO 8362-2:2008 are intended for single use only.

ISO 8871-5:2005 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle.

ISO 8871-2:2003 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.

Describes the design, dimensions, materials, performance and test for the type of closure for injection vials, as described in ISO 8362-1 and ISO 8362-4, which is used at the freeze drying (or lyophilization) of drugs and biological materials.

Contains minor amendments and adds two new annexes.

Specifies the design, dimensions, material, performance, requirements and test for the type of closure for infusion bottles, which is used in connection with the freeze drying (or lyophilization) of drugs and biological materials.

The elastomeric parts generally called "rubber" may vary considerably in their composition with regard to fillers, softeners, pigments and other auxiliary ingredients. This standard defines procedures for identifying and classifying elastomeric parts for primary packs and medical devices used in direct contact with the preparations. To avoid any affection of the preparations the 12 normative annexes specify test methods for individual applications.

Specifies the design, dimensions, material, performance, requirements and tests for single-use closures for injection vials covered by ISO 8362-1 and ISO 8362-4. The three normative annexes contain test methods for the penetrability by means of a needle and the subsequent self-healing of the closures.