ENVIROSAFE™ ASEPTIC ISOLATORS ......always in safe hands Established 1858 Sterility Test Isolators
ENVIROSAFE™ ASEPTICISOLATORS
......always in safe hands
Established 1858
Sterility Test Isolators
2
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
[email protected] 1858
HoworthAirTechnologyInc.782Route9,UnitBBayville,NJ08721,US
T: +1(484)2523860
......always in safe hands
WORKSAFE™ DOWNFLOWBOOTHS
ULTRASAFE™ CONTAINMENTISOLATORS
ENVIROSAFE™ ASEPTICISOLATORS