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MRX002Pressuretesting- November2016
WhypressuretestMRX002?MRX002vialshavebeendesignedaslaboratorytoolsforthestudyofHFApMDIformulations.Theseweretestedforpressureresistance.TheburstpressuresrecordedinthisdocumentestablishthepressurelimitsandofMRX002vials.
ExperimentalTheburstpressuresof35MRX002vialswererecordedwiththeDHIndustriesLtdburstpressuretester(0325/100).MRX002vialswerefastenedsecurelytothetester,filledwithwaterthatwaspressurisedataconstantrate(1.3bar(g)/s)untilburstingofthevial.Thevialpressurewasrecordedevery100ms,andthepressuregaugewasaccuratewithin0.01bar.
ConclusionTheaverageburstpressureis50.1±4.2bar(g),rangingfrom41to56bar(g).
ThisiswellabovethevapourpressureofHFAsatroomtemperature(max5.7bar(g)forHFA134a),andat60oC(16.8bar(g)),asrequiredforleaktestingbytheFDA.
AboutMerxin:Merxinisagenericmedicaldevicedevelopmentcompany.Developmentandsupplyofgenericinhalationdevicesas“offtheshelfandreadytouse”forfinishedproductdevelopmentisourcorebusiness.Bysupplyingstandardised off-the-shelfdevices,Merxinprovidesclientswithaquickerlowercostandlowerriskroutetomarket.
Contact:Merxincanbecontactedat:[email protected] andviaourwebsite:www.merxin.com
Generic MedicalDevicesMadeEasyCopyrights:MerxinLtd2016© November2016
Thecontentofthisdocumentcanbechangedatanytime.PleasecontactMerxinforlatestversion.
BurstpressureBar(g)
Max 56.24Min 41.19
Average 50.1StDev 4.2
Median 51.51stquartile 46.23rdquartile 52.8
Results
35
40
45
50
55
60
65Bar(g)
Max
Min
AverageMedian
3Q
1Q
N=35vials,fromonesinglebatchRoomTemperature:22oC
Units:bars HFA227 HFA134a Propane Isobutane
20oC 3.90 5.72 7.51 2.75
60oC 11.75 16.82 18.54 7.76
ThesemeasurementswerecarriedoutinpartnershipwithDHIndustriesLtd
MRX002vialsburstpressuresrangefrom41.2bar(g)to56.2bar(g),withanaverageof50.1bar(g)andamedianof51.5bar(g).Thevapourpressureofcommonpropellantsare(bar):
MRX002vialsburstpressuresarehigherthanthevapourpressuresofHFA227,HFA134a,PropaneandIsobutane.TheFDArequiresthatHFApMDIproductsbetestedatupto60oCforupto3minutes.ThevapourpressuresofthepropellantsatthistemperaturearelowerthantheMRX002burstpressure.AmorphousPETsoftensat67oC,thereforecareshouldbetakenwhentestingMRX002samplesat60oC.
