ISO 8871-5:2016 pdf free download.Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing.
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.
Elastomeric or rubber closures for pharmaceutical use are used in combination with vials and many times in conjunction with piercing devices. There are three functional parameters which are important to the piercing process. These are penetrability, fragmentation and self-sealing. The three functional tests described in this part of ISO 8871 can be used as a reference method for testing elastomeric closures that are pierced using injection needles made from metal. In addition, the aqueous solution tightness test can be used to verify the effectiveness of the sealing of a specific closure/vial combination.
2 Normative references
ISO 7864, Sterile hypodermic needles for single use;
ISO 8362-1, njection containers and accessories – Part 1: Injection vials made of glass tubing;
ISO 8362-3, Injection containers and accessories – Part 3: Aluminium caps for injection vials;
ISO 8362-4, Injection containers and accessories – Part 4: Injection vials made of moulded glass;
ISO 8362-6, Injection containers and accessories – Part 6: Caps made of aluminium-plastics combinations for injection vials.
4.2 Fragmentation
When tested in accordance with Annex B, the number of elastomeric fragments per 48 piercings visible with the naked eye shall not be greater than 5.
4.3 Self-sealing and aqueous solution tightness
When tested in accordance with Annex C, none of the vials shall contain any trace of coloured solution when observed with the naked eye. This requirement applies to multi-dose containers only, i.e containers which utilize elastomeric closures that are pierced multiple times.
Materials that meet the requirements are not required to undergo further testing in accordance with 4 4 4.4 Aqueous solution tightness.
When tested in accordance with Annex D, none of the vials shall contain any trace of coloured solution when observed with the naked eye.