ISO 8362-5-2008 pdf download

ISO 8362-5-2008 pdf download.Injection containers and accessories – Part 5: Freeze drying closures for injection vials. 44 The freeze ng closure .h be deeqned and manufactured In such a way that the removal of the reconstituted p.oduct with a hypodermic needle i be viaualy controlled ii order 10 mInimize the amount at residual plo8jct 49 When freeze &ying closures e put vi place for tie lyoplidizamon process and the container is exposed to transportaon processes, they should eshibit sufficient shock and vibration resistance that. under regular processing conditions, they do not tel off or beaxne dtilorted 5 DesIgnation A freeze drywig closure or lnlectlon viels can be designated by the words Ireeze drying cloeure followed by the number of this part alSO 6362 lollowed by the nonwial see. EtAkIPLE A treeze ying ckisi.we of ncininal size IS conying ti the requIremeis laid wn vi this part ol ISO 8362 is designated as 105ow Frees, drytng closure ISO 8362-5 —13 6 Material The el.stom.nc material used shall m.d tie requir.m.nts sp.citled r Claus 7. The elestomerIc material chat withstand two s*enllzalion cycles when eutoctaving In saturated steam at (121 ± 2) C for 30 mm edho exceeding the specified linda and without enpairmeni of its perfom’mance characteristics under conditions of normal use. In cese other steflzation methods ere used. e.g irraation, tie susabulity of the matinal shal be .velueted. With regard 10 the spec*al requirement for low residual moisture, tie drying process shat be Included vi the evaluation at the material’s performance diaractenslics (see alsO 727). Closures sham be made from ie elaslomenc formulation ongmally tested and proved by the end user. The closure manufacturer shall ensure the conformance of each delivery with tie type sample and the compliance esti previously agreed funCtiOnal and compendeal reqLeni.nti NOTE II 4 current pr&bc. to pr.fw .Iaisorenc ttortaI, that use .ttaigPmt ot halogenalail bA4 rubbws a.. bMe polymer, since Sits olass of maten eiddats an eticelient bainer funcaon against aster vapour aid gas permeabon 7 P.rformance requirementa 7.1 General The requirements specified In 72 to 74 represent mwwnum requirements which refer to the conölion of the ebstomeflc closures on receipt by the user 7.2 Physical requirements 7.2.1 Hardness The hardness agreed between manufacturer and user shall not differ from the nominal vamje by more than *5 Shore A when lasted in accordance with ISO 7619-1 cii a special lest speonien. Alternatively, the hardness can...