ISO 8871-5:2016 pdf free
ISO 8871-5:2016 pdf free.Elastomeric parts for parenterals and for devices for pharmaceutical use
This part of ISO 8871 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.
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 7864, Sterile hypodermic needles for single use
ISO 8362-1, Injection containers and accessories一Part 1: Injection vials made of glass tubing
ISO 8362-3, Injection containers and accessories一Part 3: Aluminium caps for injection vials
ISO 8362-4, Injection containers and accessories一Part 4: Injection vials made of moulded glass
ISO 8362-6, Injection containers and accessories一Part 6: Caps made of aluminium-plastics combinations for injection vials
operation four times for each closure, piercing each time at a different site. Use a new needle for each closure and check that the needle is not blunted during the test.
Pass the liquid from each of the 12 vials through a filter (B.3.7) having a pore size of 0,5 um and count the number of particles visible with the naked eye. The count is based on the assumption that fragments with a diameter equal to or greater than 50 um are visible with the naked eye. In cases of doubt or dispute, count the rubber fragments with a microscope or magnifying glass (B.3.9) to verify their size and nature.
Elastomeric closures for pharmaceutical use are commonly used in conjunction with vials. The closure ensures an appropriate seal with the vial. Poor closure/vial seal integrity and/or poor self-sealing can affect the sterility of the vial contents, product volume and concentration of doses.
Many elastomeric closures for pharmaceutical use are used in conjunction with injection needles. For multiple-dose containers, the closures may be pierced many times over the course of delivering all the doses. Self-sealing or reseal of the incision made by the needle is important to the container integrity.ISO 8871-5 pdf download.
