MicrobialAirMonitoringofCri0calProcesses

GethinJones

EnvironmentalMonitoringSolu1ons

•  PinpointScien0fic-Founder

•  Smallinstrumenta0oncompanybasedinBridgend

•  DesignManageratBiotrace&3M(16years)

•  Technologies-Microbialdetec.onproducts:

•  ATPBioluminescence(instruments&swabs)•  Military-liquid&airbornebiodetec0on•  Pharmaceu.calairsamplers

•  Primaryfocus-rapidhygienetestsforfood&beverage

•  Biotraceacquiredby3Min2006

•  FlagshipproductCleanTraceNG&swabs

Background

•  Biotrace–pharmaairsamplersbyacquisi0on

•  MaOsonGarvin–1960sdesign

•  DevelopedtheAirtrace

•  GJ-InheritedAirtrace

•  Stabiliseddesign

•  Fundamentally-designnot‘ideal’formarket

•  OpportunitytodevelopabeOerproduct

•  LeW3Min2011–tofocusonairsamplers

AirTraceAirSampler

History

MaOsonGarvinAirSampler

•  Aim–todeveloparangeEMproductsforPharma

•  Keytarget-AstraZeneca

•  UK’sbiggestuserofAirtrace•  Monitoringoversampling•  LookingforAirtracealterna0ve•  Establishedrela0onship

•  Manymee0ngs–“theidealairsampler”

•  2015PinpointScien0ficchosenfornew$200MSPP5plant

•  Pinpointstatusatthe0me….

•  Ini0alorder38systemswith85deliveredtodate.

•  SPP5nowsterilewith3000+runstodate

•  SPP6sanc0oned-PinpointScien0ficchosenagain

ConcepttoReality

ChosenConcept DeliveredProduct

Rangeofenvironmentalmonitoringproductsandaccessoriesforuseincleanroomsandassociated

controlledenvironments

OurGoal

SurfaceSampler Asep0cPlateHandling

Isolator&RABS

Cleanroom

•  Cleanroommonitors

•  Isolators&RABSmonitors

•  Rapidairsamplers

•  Surfacesamplers

•  Asep0chandlingaccessories

MicrobialAirSampling&Monitoring

Whydowedoenvironmentalmonitoring(EM)?

Regula.ons….Applicableregula0onsforSterileManufacturingintheEUmarketandMonitoringofOpera0ngTheatresinHospitals:

1.  Annex1oftheEUGuidetoGoodManufacturingPrac0ce(OrangeGuide)

2.  UNI-EN-ISO14644/1-2-3forcleanroomclassifica0onandtes0ng.

3.  UNI-EN-ISO14698/1-2forbio-contamina0oncontrolincleanrooms.

4.  Pharmacopoeias:USP,JP,EP

5.  HTM03-01referringtoMicrobiologicalCommissioningandMonitoringofOpera0ngTheatreSuites

MicrobialAirSampling&Monitoring

TheE.C.GuidelinetocGMPrecommendslimitsforEnvironmentalMonitoringofcleanareasduringopera0on(0esinwiththeFDAguidelineonthepreviousslide)

MicrobialAirSampling&MonitoringMethods

PassiveMonitoring•  SeOleplates

•  MicroorganismsseOleontothemedia•  Airtoagar•  CaptureàGrowàIden0fy

Ac0veSampling&Monitoring•  Slit-to-agar

•  Airdrawnthroughnarrowslit•  Airtoagar•  CaptureàGrowàIden0fy

•  Sieve•  Airdrawnthroughperforatedplate•  Airtoagar•  CaptureàGrowàIden0fy

EnhancedPar0cleCounters-Real0me&Monitoring•  Laserbasedpar0clecounter•  Con0nuous&real0me•  Noconsumable•  Advancedalgorithms•  Auto-fluorescence=probabilityoforganism•  Noiden0fica0on

SeOlePlate

Sieve

Slit-to-Agar

EnhancedPar0cleCounter

MicrobialAirSampling&Monitoring–AgarBased

Keyairsamplerrequirementstomeetregula0ons

•  Physicalefficiency(Theore0cal&test)-sampledowntolessthan1µmpar0cles(D50<1)

•  Biologicalefficiency(Bytest–PHE)-Viabilityoforganismtogrowandiden0fy

•  Sampleminimum1m³-withoutdryingoutofmedia

•  Iden0fyorganism

•  Appropriatesepara0onofcoloniesinhighcontamina0onareas

•  Doesnotshedpar0cles(contaminatetheenvironment)

Ac1veAirSampler-Principle

MicrobialAirSampling&Monitoring–AgarBased

WhatistheD50onyoursampler?

Sampling(sieve)vsMonitoring(slit)

•  Slit-to-agar•  Airdrawnthroughnarrowslit•  D50<0.5µ•  Rota0ngagarplate•  Larger140mmAgarplate•  Upto4hoursononeplate=monitoring•  Lowdehydra0onofmedia•  Excellentsepara0onofcolonies•  Timecorrelatedresults

•  Sieve•  Airdrawnthroughperforatedplate•  D50(best0.8butgenerally>1.1)•  Fixedagarplate•  Smaller6cmor9cmplate•  Typically10minutessample0me•  Sampleovershortperiodsonly•  Mediadehydra0on•  Poorcolonysepara0on(lookuptable)•  ‘Twinimpingement’

Slit

Sieve

T=0

T=33minutes

Overview-ImpactAir®

•  ImpactAir–AirSampler&Monitor•  FullyvalidatedforISO14698-1•  ClassleadingD50<0.5µ•  Uniquedynamicheightadjustment*•  ConstantD50throughoutrun*

•  140mmAgarplate•  RobuststainlessSteelconstruc0on•  ProvenTechnology•  Doesnotshedpar0cles•  Ultralowvibra0on

•  Lowpower(<60waOs)•  Op0onalremotecontrol•  Flexibledeploymentop0ons•  50%footprintcomparedtoAirtrace•  HEPAFilteredExhaust

*IPprotected

Sieve–Dotheycomply?

Isolators&RABS

•  Humans=maincontamina0onsource

•  Industrymovetowards“separa0vebarrier”RABS&Isolators•  Ismonitoringrequiredatall?•  Governedbysamerules&regula0ons

•  Restrictedspace

•  Monitorstoolarge–fuelssievesamplermarket

•  Challengetocreatesmallmonitor

Regula0onChanges

Regula0onsarechanging:(CleanroomTechnologyConferenceSept2017)

•  Moreemphasisoncon0nuousbiologicalmonitoring

•  Evidencebaseddata

•  ‘ControlStrategy’required(newPHSSrequirement)

•  GradeA=<1CFU–cannottrendZERO-thereforecurrentmethodsarereac0veatbest

•  Contamina0on‘walkedin’–DàCàBàA

•  Trending,mapping&devia0onemphasisacrossallareas

•  Predic0ve&preventa0veemphasis

•  Allowtheuseofenhancedpar0cledetectors(CFUàBio-Event)

•  Growthinbiologicallyac0vedrugs

•  Cannotbeterminallysterilised

•  In-situsterilisa0oncandamageproduct

•  S0llneedtoiden0fyorganismspecies

•  Needforasmallermonitoringsolu0on–butisolatorsgenerallycustomdesign

FlexibleRABS&Isolatorsolu0onsfor

Con0nuousMicrobialMonitoring

SlightlyConfiden.al!

AnythingisPossible…….

ImpactAir140-ISO

ImpactAir140-ISO

MonitoringHead

Pump&Electronics

RemoteControlUnit

ImpactAir140-ISO

ImpactAir140-ISO•  ImpactAir–AirSampler&Monitor•  FullyvalidatedforISO14698•  ClassleadingD50<0.5µ•  Uniquedynamicheightadjustment*•  ConstantD50throughoutrun*

•  140mmAgarplate•  RobuststainlessSteelconstruc0on•  ProvenTechnology•  Doesnotshedpar0cles•  Novibra0on

•  Lowpower(<60waOs)•  Remotecontrol•  Flexibledeploymentop.ons•  LowandZerofootprint•  SoWClosechamber

*IPprotected

ImpactAirSizeComparison

ImpactAirSizeComparison

FlexibleDesign-Moun0ngBoss

UniversalMoun0ngBoss

‘SoWConnec0on’–DirectHose&Cable

FloorMount(Prefabricated1½Tube&fiyngs) WallMount(1½ClampFiyngs)

BespokeorDIY

Hose&ControlCable

AnythingisPossible…….

ImpactAir140-ISO

•  ‘Gamechanger’inRABS/isolatormonitoring•  Designatadvancedstage•  Commitmentfor20already•  Orderfor35compe0torsystemshalted•  Inproduc0on2ndQTR2018

•  Member’sofstandardscommiOeelikeit!•  Thinktwicebeforebuyingasievesampler!

ThankYou