ENVIROSAFE™ ASEPTICISOLATORS

......always in safe hands

Established 1858

Sterility Test Isolators

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Forareliable,6-logreductionofmicro-organismstocreateasterileenvironmentforthetestingofpharmaceuticalproducts,youneedasolutionthatprovidesuncompromised,totalbarrierisolation

Sterility testing is one of the most crucial steps inensuring the safetyof yourproducts. The introductionof contaminants throughequipment failure andhumanerror can cost you time, money, and ultimately, yourproduct.

BenefitsofBarrierIsolation

Theuseofasepticbarrierisolationtechnologycanaffordsignificantbenefits:

• IncreasedSterilityAssuranceLevels(SALs)

• Reduction in false results and consequent productwastage

• Costsavings

ProductProtection

People are the biggest source of contamination incleanrooms; even under optimal conditions, a gowned,motionless humanmay generate 100,000 particles perft3/min. Aseptic barrier isolation technology offers thecompleteseparationofpersonnelfromthetestsample,ensuringpureprotectionforyourproducts.

IncreasedSterilityAssurance

Using an aseptic isolator will completely separate theproduct from possible sources of contamination, givingyouthepeaceofmindthatyourproductisbeingtestedunderasepticconditions.

ReduceProductWastage

Product testing within isolated conditions reduces thefrequency of generating false results. Consequently,the occurrence of product re-testing and recall is alsoreduced,savingyoutime,money,andyourproduct.

ReducedOperationalCosts

The complete separation of the internal and externalenvironment means that the surrounding area can beoperatedatamuchlowerclassification,andconsequentlylowercost.

• Smallerworkspacefootprintlowersutilitycosts

• Automateddecontaminationprocess

• Reducedgowningandtrainingcosts

• Ergonomicspace-savingsolution

AsepticIsolator-StandardFeatures

• IntegratedH2O2decontaminationsystem

• 6-logreductionofmicro-organisms

• GradeAinternalenvironmentISO14644Class4.8

• Positivepressureoperationforproductprotection

• Integratedleakdetectionsystem(auto-decaytest)

• Controlsandoperatorinterfaces

ENVIROSAFE™ AsepticIsolators

3

• DoubleHEPAfilters

• Unidirectionalairflow

• Fullyfabricatedstainlesssteelchamber(s)

OptionalExtras

• Gassinghatch

• Internaltrolleytransfersystem

• Gloveportsavailableinvarioussizes,materialsandconfigurations,toaccommodateawiderangeofergonomicmovement

• Integrationofthird-partyequipment(includingMilliporeandSartorius)

• Footrests

• Raise/lowerlegs

H2O2DecontaminationSystems-BioGen™

The isolator is designed with its own fully integratedBioGen™decontaminationsystem,controlledviatheon-boardHMI.Alldecontaminationcyclesareautomaticallysequenced.

Full integration of the BioGen™ system eliminates theneed for operators to handle delivery hoses, electricalinterfaces,andvalves,betweendecontaminationcycles,removingtherelianceonSOPs.

BioGen™ includes the Howorth BioSonic™ nano-micro misting process, which is a unique, ultra-highperformance liquid shear system. This systemprovidesa perfectly balanced mix of both nano/micro-mist andvapour,andcombinesexceptionalbio-decontaminationwithoustandingefficacy.

Controls&OperatorInterface

The isolator is equipped with a PLC control systeminterfaced with all system hardware and sensors,developedinaccordancewiththeGAMPguidelines.Theisolator isoperated fromanon-board touchscreenHMI(HumanMachineInterface).

Standardfunctions

• Operatingmodeandstatusdisplays

• Parametermonitoringdisplays

• Systemalert/warning/alarmdisplaysandaudiblesounder

• Automaticintegritytestingfunction

• Automaticdecontaminationmodecontrolsanddisplays

• Restrictedaccesssupervisorandengineeringfunctions

• Criticalcycleparameterprint-off

Bio-decontaminationCycleTimeReduction

In developing any decontamination cycle there is abalance to be made between the need to ensure anadequatebio-decontaminationkillrate,andthedesiretominimisecycleduration.

Howorth has been able to utilise design techniques, tohelpwiththeoptimisationofthedecontaminationcycle.Through the enhancement of the isolator’s internalaerodynamic characteristics,we are able to ensure themosteffectivedispersionofH2O2withintheenclosuretoachievethe6-logreductionofmicro-organisms.

TransferSystems

Howorth can offer an extensive range of transfersystems. Whether our own BioGen™ system or third-party solutions,weare sure tohavea transfer solutionto meet with your process and ergonomic needs.

Commissioning,ValidationandAftermarketSupport

Howorthisabletoprovideafullsuiteofafter-salessupportservices, including, installation,andcommissioning,SAT,and validation (including aseptic validation), togetherwithacompleterangeofOEMspareparts.

HoworthAirTechnologyLtd.LorneStreet,FarnworthBolton,BL47LZ,UK

T: +44(0)1204571131F: +44(0)1204862378

info@howorthgroup.comwww.howorthgroup.comEstablished 1858

HoworthAirTechnologyInc.782Route9,UnitBBayville,NJ08721,US

T: +1(484)2523860

......always in safe hands

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