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AAPSPharmSciTech(2021)22:53
DOI:10.1208/s12249-021-01921-2
ResearchArticle
EquipmentCapabilityMeasurementofLaboratoryFreeze-Dryers:aComparison
ofTwoMethods
JayasreeM.Srinivasan,1,5GregoryA.Sacha,1VaibhavKshirsagar,2AlinaAlexeenko,3,4andStevenL.Nail1
Received20October2020;accepted4January2021
Abstract.Theobjectiveofthisinvestigationwastoevaluatetwomethodsformeasuring
themaximumsublimationratethatafreeze-dryerwillsupport—theminimumcontrollable
pressuremethodandthechokepointmethod.Bothmethodsgaveequivalentresults,butthe
minimumcontrollablepressuremethodispreferred,sinceitiseasier,faster,andless
subjective.Theratioofchamberpressuretocondenserpressurecorrespondingtotheonset
ofchokedflowwasconsiderablyhigherinthisinvestigation(uptoabout20:1)thanin
previouslypublishedreports.Thisratiowasnotaffectedbythelocationofthepressuregauge
onthecondenser;thatis,ontheforelineofthevacuumpumpversusonthebodyofthe
condenseritself.Thetotalwaterlossduetosublimationasmeasuredbytunablediodelaser
absorptionspectroscopywasconsistentlywithin5%ofgravimetricallydeterminedweight
loss,regardlessofwhetherthemeasurementtookplaceduringchokedversusnon-choked
processconditions.
KEYWORDS:equipmentcapability;minimumcontrollablepressure;chokepoint;chokedflow;tunable
diodelaserabsorptionspectroscopy(TDLAS).
INTRODUCTION
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