Hydrogen peroxide vapour technology 2009

Overview of BIOQUELL Pharma’s Clarus H2O2 gaseous bio-decontamination technologyDon Bissell Managing Director BIOQUELL PharmaHydrogen Peroxide Gas Basic Factsy Vapour formed from flash evaporation of hydrogen peroxide solution y Compatible with most materials, except nylon and some rubbers y Readily decomposes to water and oxygen 2H2O2Catalyst2H2O + O2y Aqueous solutions stable at high concentrations y Gas remains stable up to 425ºC highly effective, residue-free biocideH2O2 Gas - micro-biological efficacyy Selected micro-organisms which H2O2(g) deactivatesBacillus stearothermophilus Mycobacterium smegmatis (microbiological proxy for TB) Clostridium sporogenes spores Salmonella typhimurium aerobic Pseudomonas aeruginosa Orthomyxoviridae Reoviridae Herpesviridae Aspergillus spores Candida albicans Gram -ve rod, aerobic Virus RNA Single strand Virus RNA Double strand Virus DNA Double strand Fungus Yeast Gram +ve Gram -ve rod, fac Gram +ve rods, endospores Gram +ve rod unique groupH2O2 Gas - Bio-decon ApplicationsUsed in gaseous form in Pharma since 1990 85% of all aseptic processing isolators use H2O2 for bio-decontamination Rooms Material airlocks IVC’s MSC’sReplacing Replacing peracetic peracetic acid acid and and formaldehyde formaldehyde as as bio-decontaminant bio-decontaminant of of choice choice Increasing interest and support from regulators - VMD,FDA, MCA, HSEFormaldehyde factsDifficult to validate Carcinogen, banned in ScandinaviaSlow action and long cycle timesMajor Major health health & & Formaldehyde Formaldehyde safety safety issues issuesRequires high humidity to be effectiveDifficult to aerate, strong persistent odourLeaves residue of ParaformaldehydeFlash EvaporationAir StreamVapour MixtureHot Plate >100ºCFlash evaporation: All the components are instantly vapourisedHigher O2 vapour achieved than the Higher concentration concentration of of H H 2 2O 2 vapour achieved than the equilibrium equilibrium state stateConcentration and condensationH2O2 Vapour Pressure (ppm)1400 1200 1000 800 600 400 200 0 0Typically the point of initial formation of condensation 682 ppmDerived from BIOQUELL “dew point” formula at 40% RH267 ppmEquilibrium vapour pressure at 25 °C102030 35% 4050 55% 6070Aqueous Solution Concentration (%)Formation of micro-condensationHot gas delivered (typ. 60ºC)Raised H2O2 concentrationCold gas exhausted (typ. 20ºC)Formation Formation of of micro-condensation micro-condensation „ „ essential essential to to achieve achieve kill kill „ „ not not always always visible visibleVapour CondensationCondensation of vapour on lyophilised spores of Bacillus macerans on silanized glassTime = 0 secby M.-A. Marcos, A.Bardat. R. Schmitthaeusler, and D. Beysens.Time = 0.5 secTime = 3 secFrom “Sterilization by Vapour Condensation” Pharmaceutical Technology Europe Feb 1996 Vol.. 8 No. 2Condensation MonitorHow it works : Gassing Environment Light Escapes CondensationGlass Window Optical Pad Prism LensOutputLight SourceLight Sensor1.00E+001.00E+031.00E+06161116Gassing Time MinutesS u r v i v o r sRapid kill after condensation achievedElectrical Equipment Test gassed over 200timesElectrical Equipment Test gassed over 200 times Instrument TestingInstrument Testing Computer before and during gassingComputer before and during gassingNo electronic failuresElectrical wiring undamaged Stainless steel unaffectedPainted mild steel unchanged Exposed PCB not damagedHydrogen Peroxide gassing technologypre-conditioninggassingBIOQUELL’s Clarus uses a “dual loop” H 2O 2vapour injected rapidly during gassing stage to achievemicro-condensation and hence rapid killBIOQUELL’s Clarus uses a “dual loop” H 2O 2vapour injected rapidly during gassing stage to achieve micro-condensation and hence rapid killDRYER HEATER LEAK TESTCATALYSTVAPORISERLIQUID FLOW MODULEFANROOM / CHAMBERPRESSURE CONTROLFANVALVESingle LoopMaximum roombio-decontamination n/a Dual circuit technologyyesMaximum enclosure bio-decontamination 3 mautomatic operation–easy connection to lab equipment –short cycle times–runs at negative pressure -and safety feature–pre-dispensed bottles to minimise health and safety risk–moisture removed by refrigeration –residue-free bio-decontamination –electronic safety interlock2IncubatorsMicro-biological safety cabinets and transfer stationsIsolatorsIVC systemsTransfer hatchesGreater efficacy (6-log assured)fast kill (typically 15-30 minutes gassing)fan driven for active distribution AHU or complete system decon low temperature no residues or odours safe for electronicscan be used safely in situfast kill (typically 15-30 minutes gassing) fan driven for active distribution AHU or complete system decon low temperature no residues or odours safe for electronics can be used safely in situ Safe and effective bio-decontaminationfast kill (typically 30 minutesgassing) giving 6-log bio-burden reduction distribution nozzles for activevapour distribution Uses gas generator or washerventilation system for aeration low temperature residue free saves space safe for electronics and electricalequipmentgassing) giving 6-log bio-burden reduction distribution nozzles for active vapour distribution Uses gas generator or washer ventilation system for aeration low temperature residue free saves space safe for electronics and electrical equipment Minimises space and cost of decontaminationHEPA HEPAHEPA sealed screenH2O2distribution cabinet–Insertion of the dual-flow integrator is typically achieved in less than 5 minutes by the customer –Cycle times of c. 3 hours can be expected–Negative pressure cycle ensures no leakage of the hydrogen peroxide vapour -key health and safety featureSporicidalGassingof IsolatorsRapid bio-decontamination for cage enclosures010*******4000204060Time MinutesCondensation indexVisible CondensationFractional -ve kill 10616 mins in dwellDecontamination Cycle of about 1 hour withParametric ControlBi-directional gas distribution nozzlesRoom 450m3Clarus gas generator Trace-heated flexible pipeworkInterface panelClarus C gas generatorTrace heated flexible pipework Tripod mounted gas distribution nozzles(optional)Disinfection Access corridorMaterial Airlock Change rooms Cage rooms Animal Process/Wash rooms42.5 m e t r e s 13.6 metresPre-conditioning Gassing Aeration (generator/HVAC) Lethality using Pre-conditioning Gassing Aeration (generator/HVAC) Lethality using Highly effective and unique solution for complex areaUnited KingdomTel: (44) 01264 835 853Fax: (44) 01264 835 854 E-mail: enquiries@。