ISO 8362-5:2016 pdf free

ISO 8362-5:2016 pdf free.Injection containers and accessories – Freeze drying closures for injection vials
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 d1.
The plug part shall provide slits, channels or other appropriate means, in conjunction with protruding or positioning elements at the outer diameter, which enable insertion on a drying (halfway) position during the sublimation process.
The design of the positioning element to hold the freeze drying closure firmly in the sublimation position should not compromise the full insertion of the closure into the neck of the vial.
The design of the flange part in conjunction with the plug design shall permit both the reconstitution of the freeze-dried product with the appropriate solvent and the removal of the dissolved product by means of a piercing device.
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 min without exceeding the specified limits and without impairment of its performance characteristics under conditions of normal use. In case other sterilization methods are used, e.g. irradiation, the suitability of the material shall be evaluated.
With regard to the special requirement for low residual moisture, the drying process shall be included in the evaluation of the material’s performance characteristics (see also 7.2.7).
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.
NOTE It is current practice to prefer elastomeric materials that use straight or halogenated butyl rubbers as a base polymer, since this class of materials exhibits an excellent barrier function against water vapour and gas permeation.ISO 8362-5 pdf free.