Sterility Test Isolator

Pura

A leading pharmaceutical companyreportstatedalmost25%of all lost time illnesses were caused by ergonomic relatedissues.

Telstarputgreatemphasisontheneedtoperformergonomictrials,attheonsetofallprojects,toidentifyissuesandpreventthembecomingaproblem.Modelstogetherwithtrialsservetosimulatetheprocessoperationsinvolved.

This process has already been extensively performed in thedevelopmentoftheTelstarPurarangeofSterilityTestIsolators,resultinginanergonomicallydesignedrange.

Supportedbycontinualinvestmentin3Dsoftwaretechnologyoperated by design personnel from a highly qualifiedengineering background. 3D design provides a clearervisualisation of the entire project preventing clashes andaccurateproductionof2Ddrawingelevations.

AsaninternationalleaderfocusedonQuality,Telstarpartnerswith clients toprovide technically advanced solutionson aglobalbasisthroughinnovation,absolutereliabilityandexpertprojectmanagement.

Providing in-house expertise in design (strengthened with3D design skills) and manufacture of innovative/bespokeBarrier Isolation equipment, which requires research anddevelopmentskillsonaday-to-daybasis.

Telstar strives continuously to address and adapt to everchanging industry needs, evolving inline with governmentregulationsandstringentindustrystandards.

Recognised Leaders in Sterility Testing Technology

TelstarrisestodemandsinpharmaceuticalAsepticandContainmentBarrierIsolationequipment,providingsolutionsforspecificchallengespresentedbyclients’individualrequirements.

SterilityTestingisanevermoreimportantpartofanypharmaceuticalprocess.Aclearunderstandingoftheprocessisparamounttoitssuccess.

TelstarLifeSciencesUKLtd, is thecentreofexcellencefortheAsepticandContainmentBarrier IsolationsideoftheTelstarbusinessandarefullyawarethatattentiontodetailmakesallthedifferencewhendesigningtherightsolution.

ionHP®

FollowingextensiveresearchTelstarUKhasidentifiedanalternativedecontaminationsystem,using(ionizedHydrogenPeroxide)ionHP®.

Thisbio-decontaminationsystemisanintegrateddecontaminationsystemdedicatedtoasingleSterilityTestIsolator.

This unique system provides rapid and effective sterilisation of the Isolator and isproventechnologygivingasixlogreductionofviruses,sporesandfungi.

The system produces a fine mist of hydrogen peroxide and isopropyl alcohol bypassingthroughacoldplasmaarctoionizethemedium.Onceionizeditactslikeagasprovidingexcellentdistributionandduetoitspositivechargedpropertiesreachesthosehardtoreachareas.Thisinturnreducesthesterilisationtimesoveralternativemethods.

The ionHP® system is controlled viathe Isolator PLCbased control systemandincludescompletedataacquisitionandH202chambermonitoring.

The ionHP® Advantage

9 Superiorefficacy

9 Rapidresponseandreducedcycletimes

9 ReducedSterilantquantities

9 Noexcessivetemperatureriseduringcycle

9 Temperature&Humidityhasnoeffectonthecycle

9 Excellentmaterialscompatibility

9 Minimizeddowntime

9 Environmentally-friendly(“green”)

9 Cost-effectivepricing

A comprehensive range protecting the most critical step in the production process…

SterilitytestingofsterilepharmaceuticalproductsisrequiredbythePharmacopoeiastodetermineacceptabilityofaproductionbatch.Itisanessentialelementofsterilisationvalidationanditmustbeperformedinamannerwhichavoidstherisksofbothfalsepositiveandfalsenegativeresults.

Falsepositiveresultsaregenerallyduetolaboratorycontaminationfromthetestingenvironmentortechnician/techniqueerrorandcauseadditionalworkintermsofextradocumentationrequiredandaddssignificantlytocostasitdelaysorpreventsreleaseoftheproductforsale.

TelstarPuraSterilityTestIsolatorsaredesignedtoavoidtheriskoffalseresultsandtoprotect theproduct fromboth theprocessandexternallygeneratedfactorsthatwouldcompromiseitsquality.

TheTelstarPurarangehasbeendevelopedtocoverawiderangeofclient’sneeds.Theunits’abilitytoprovideareliableasepticenvironmentforsterilitytesting and other aseptic processes is unquestioned. A minimum of log6 reduction in spore forming micro-organisms is consistently achieved &validatedusingaBIchallenge.

TheTelstarPurarangeissuitableforperformingbothDirectInoculationandFilterMembrane sterility tests with flexibility to be bio-decontaminated bydifferenttypesofsystemsavailable.

TheTelstarPuraSterilityTest Isolatorcomplies fullywith ISO14644-7:2004producinganEUGMPGradeAenvironmentthroughoutthechamber.

Telstar Pura Sterility Test Isolator range:

Telstar’s Technical Sales Team will work with you to identify your exact requirements for your Sterility Testing Isolator.

Telstar Pura 2

SingleChamberIsolatorwith2gloves.

Telstar Pura 3+

DoubleChamberIsolator(mainchamberwith3gloves+transferchamber).

Telstar Pura 4+

DoubleChamberIsolator(mainchamberwith4gloves+transferchamber).

Telstar Pura 3

SingleChamberIsolatorwith3gloves.

Telstar Pura 4

SingleChamberIsolatorwith4gloves.

TelstarPura2,3&4are for small scale sterility testingandchoiceofmodel isdependenton thenumberof tests tobeperformed.TheseIsolatorsaredesignedforsinglebatchsterilitytesting;theIsolatorsarepre-loadedwithsamplesandtestmaterialsbeforebio-decontamination.Afterbio-decontaminationthebatchistestedandthentheIsolatoriscloseddownattheendoftesting.

Telstar Pura3+&4+ are used for continuousbatch testingwhere largenumbersof sterility tests need tobeperformed.TheIsolatorispre-loadedwiththeinitialsamplesandtestmaterialsbeforebio-decontamination,afterbio-decontaminationthesterilitytestingcanproceed.AdditionalfunctionalitywiththeseIsolatormodelsisthatadditionaltestmaterialsandsamplescanbeintroducedandbio-decontaminatedviathetransferchamberwhilststerilitytestingistakingplaceinthemainchamber.Thesterilitytestingprocesscanthenbecontinuous;transferringsamplesandtestmaterialsintotheIsolatorwithoutdetrimenttotheworkingenvironment.

Main advantages of using an Isolator for Sterility Testing•NorequirementforacleanroomenvironmentsurroundingtheIsolator

•Reducedcostbynothavingtomaintainandoperatesurroundingcleanroom

•Reduced operating cost with no gowning requirements for technicians,cleaning,sterilisingandtimetogownandde-gown

•Removalofthemaincauseofcontamination(operators)fromthetestingarea

•Significantreductionintheriskoffalse-positiveresultsandthecorrespondingsavingsforinvestigationsandproductreleasedelays

•Increasedcapacityforsampleanalysis

•Enhancement of compliancewith domestic and international guidelinesandexpectations

•Portability(SterilityTestIsolatorscanberelocatedeasily)

Key features and benefits:• Positivepressurewithalarmsetpointstoavoidanyproductcontamination.

• Singlepassturbulentflow(EUGMPgradeA)tomaintainsterileconditionsinsidetheIsolator.

• The glass vision panels are ‘gull wing’ type which hinge upwards andoutwards.Intheopenpositionthedoorsareheldopenwithgasstruts.

• Inflatable seal technology on all doors assures very low leakage rate incompliancewiththemoststringentleakagecriteriastatedinISO14644-7.

• HighresistancetoH202withoutgivingrisetoexcessiveoutgassingandthusminimisingbio-decontaminationcycletime.

• Designsuitableforbio-decontaminationusingabroadrangeofsystemstofulfiluserrequirements.

• Integrated or stand alone bio-decontamination system or unique TelstarionHP®system.

• PLCbaseduserfriendlyautomatedcontrolwithautomaticleaktestfunction(pressureholdtest).

As standard the units include:• Internaltemperature&humiditymonitoringsensors.

• Oval shaped gloveports designed for sound ergonomic posture whilstmaximizingoperatorarmmovement.

• GlovesareathreepartdesignwhichenableschangingofaglovewithoutcompromisingIsolatorsterility.

• Grade AISI 316L stainless steel, fully welded, crevice free with smoothinternalsurfacesguaranteescompletecleanability.

• SupportframemanufacturedfromAISI304Lstainlesssteel.

• Lightingfixtureswithineachchamberwithexternalaccessformaintenance.

Options available for the Telstar Pura Sterility Test Isolator range:

Factory Fitted Options•Bio-decontaminationSystem

•SterilityTestPump

•GloveTester

•PaperlessChartRecorder

•Automatedraise/lowerSupportFrame

•H202externalMonitoringSensor

•AlternativetypesofTransferPorts

•InternalShelving&Racking

Ancillary Options•NonViableMonitoring

•ViableMonitoring

•ContinuouslinerGrommetforGammaIrradiatedlinersorbags

•ContinuousLinerbagwelder

•BagWeldermobiletrolley

The production site where the products are made has been assessed and given ISO 9001:2008 approval

All equipment is manufactured to allow it to be CE marked in accordance with 98/37/EC Machinery Directive.

TELSTAR Life Sciences UK Ltd.Unit4,ShawCrossBusinessParkDewsbury,WestYorkshireWF127RF(UK)T.+44(0)1924455339www.telstar-lifesciences.com

TELSTAR Life SciencesHeadquartersAv/FontiSagué,55ParcCientíficTecnològicOrbital4008227Terrassa(Spain)T.+34937361600F.+34937859342

TELSTAR North America Inc.1504Grundy’sLaneBristol,PA19007(USA)T.+12158260770F.+12158260222

Fully CompliantTelstarPuraSterilityTestIsolatorsareguaranteedtocomplywithrelevantstandardsanddemandssetbytheregulatorybodiestoensureconformanceandclient’ssatisfaction,including:

•FS209EAirborneParticulateCleanliness

•cGMPGuidelines(currentGoodManufacturingPractices)

•ISPEGuidelines(TheSocietyofPharmaceuticalandMedicalDeviceProfessionals)

•FDA(FoodandDrugAdministration)

•MCA(MedicalControlAgency)

•AmericanGloveboxSocietyGuidelines

Telstar provides a comprehensive validation service to clientsprovidingFAT/SAT/DQ/IQ/OQ&PQprotocolsifrequired.

Additionally Telstar UK has a dedicated Customer Servicedivisionwhoofferacompletepackagetoensureyourequipmentisworkingcorrectlyandefficientlyatalltimes.

Sterility Test Isolator

Pura