Advanced Biodecontamination Solutions Vaporized Hydrogen Peroxide (VHP Vaporized Hydrogen Peroxide (VHP ® ® ) ) Advanced Biodecontamination Advanced Biodecontamination Solutions (ABS) : Solutions (ABS) : 'GREEN' Technology for the Highest Level of 'GREEN' Technology for the Highest Level of Microbial Control within a Life Science Facility Microbial Control within a Life Science Facility Prepared by Prepared by Peter Harris and Nick Flynn Peter Harris and Nick Flynn B & V TESTING, INC. B & V TESTING, INC. STERIS STERIS - - Certified VHP Application Specialists Certified VHP Application Specialists Northeast: 86 West St, Waltham, MA 02451 Northeast: 86 West St, Waltham, MA 02451 Mid Mid - - Atlantic: 3 Vale Rd, Bel Air, MD 21014 Atlantic: 3 Vale Rd, Bel Air, MD 21014 www.bandvtesting.com www.bandvtesting.com 800.851.9081 800.851.9081
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Agenda Agenda •• Introduction to Advanced Biodecontamination Introduction to Advanced Biodecontamination
Solutions (ABS), a joint service offering from Solutions (ABS), a joint service offering from B & V TESTING, INC. and STERIS CorporationB & V TESTING, INC. and STERIS Corporation
•• VHP Background and HistoryVHP Background and History•• Overview of the VHP Process: efficacy, safety, Overview of the VHP Process: efficacy, safety,
regulatory landscape, environmental properties and regulatory landscape, environmental properties and material compatibilitymaterial compatibility
•• VHP Technology and EquipmentVHP Technology and Equipment•• VHP Biodecontamination Field ApplicationsVHP Biodecontamination Field Applications•• VHP Services and Project Planning VHP Services and Project Planning •• Case StudiesCase Studies
Advanced Biodecontamination Solutions
B & V TESTING and STERIS B & V TESTING and STERIS Advanced Biodecontamination Solutions (ABS)Advanced Biodecontamination Solutions (ABS)•• ABS: a Flexible service offering matching the field service expeABS: a Flexible service offering matching the field service expertise of rtise of
B & V TESTING with STERIS VHP technology and EPAB & V TESTING with STERIS VHP technology and EPA--registered registered consumablesconsumables–– Contract Contract VHPVHPbiodecontamination services and Sporbiodecontamination services and Spor--Klenz RTU Klenz RTU
•• National leader in biodecontamination and National leader in biodecontamination and contamination control technologies testing, contamination control technologies testing, certification and maintenance services: certification and maintenance services: –– 30 years experience performing gaseous 30 years experience performing gaseous
–– Testing, Certification and Maintenance of Testing, Certification and Maintenance of Cleanrooms, Biological Safety Cabinets, Cleanrooms, Biological Safety Cabinets, and HEPAand HEPA--filtered systemsfiltered systems
••STERIS is a global leader in infection STERIS is a global leader in infection prevention, contamination control, surgical prevention, contamination control, surgical and critical care technologies, and more. and critical care technologies, and more. Manufacturers of EPA registered VaproxManufacturers of EPA registered Vaprox®®35% and 59% hydrogen peroxide (EPA reg. 35% and 59% hydrogen peroxide (EPA reg. no. 58779no. 58779--4), Spor4), Spor--Klenz (EPA reg. no. Klenz (EPA reg. no. 5225252252--44--1043 and VHP1043 and VHP®® technology technology
•• Contamination remediationContamination remediation•• PrePre--occupancy new or renovated facilityoccupancy new or renovated facility•• Preventative periodic bioPreventative periodic bio--burden reduction burden reduction •• Product/population changeProduct/population change• Equipment transfer • Facility decommissioning• Equipment maintenance, i.e. BSCs, HEPA housings,
etc.
Advanced Biodecontamination Solutions
VHP: Background and History VHP: Background and History •• VHP process developed midVHP process developed mid--1980s, utilizing patented 1980s, utilizing patented
closedclosed--loop, low concentration loop, low concentration ““drydry”” processprocess•• VHP process patent issued in early 1990sVHP process patent issued in early 1990s•• Over 1,200 VHP systems in use worldOver 1,200 VHP systems in use world--wide in wide in pharmapharma, ,
med device, LAR, biomed device, LAR, bio--containment fieldscontainment fields•• 15+ years of validated use in pharmaceutical 15+ years of validated use in pharmaceutical
manufacturingmanufacturing•• Large scale VHP facility applications applied for Large scale VHP facility applications applied for
remediation during 2001 anthrax attacksremediation during 2001 anthrax attacks•• 20062006--Present VHP contract service available to industry Present VHP contract service available to industry
through ABS STERIS/B & V offering, 150+ Projectsthrough ABS STERIS/B & V offering, 150+ Projects
Gas Concentration: for roomdecon typically 150-700 ppm
Relative Humidity
Condensation Point
Rh start target: typically 30-50%
Advanced Biodecontamination Solutions
…if you can see it, it’s not a vapor
Boiling Points:H2O 100°CH2O2 150°C
Vapor orVapor or Condensate? STERIS VHP is Condensate? STERIS VHP is a DRY Processa DRY Process
Advanced Biodecontamination Solutions
Variables Affecting EfficacyVariables Affecting Efficacy•• Temperature and humidity affect how much hydrogen Temperature and humidity affect how much hydrogen
peroxide (HP) can be generated in the gas state, start Rh peroxide (HP) can be generated in the gas state, start Rh typically 30typically 30--50%50%
•• ConcentrationConcentration——typically 150typically 150--700 ppm room applications700 ppm room applications(injection rate/ air flow ) * wt. % of HP(injection rate/ air flow ) * wt. % of HP
•• SaturationSaturationInject as much as possible but below dewInject as much as possible but below dew--pointpointHumidity is good for microbial killHumidity is good for microbial kill
•• DistributionDistribution——may be facilitated with fansmay be facilitated with fans•• Materials which can reduce VHP concentration, cellulosic Materials which can reduce VHP concentration, cellulosic
material (i.e. cardboard, paper), galvanized steel, standing material (i.e. cardboard, paper), galvanized steel, standing waterwater
Advanced Biodecontamination Solutions
Why VHP? EPAWhy VHP? EPA--Registered SterilantRegistered SterilantSporicidal at Low Concentrations (toughest kill)Sporicidal at Low Concentrations (toughest kill)
•• Bacterial Spores Bacterial Spores -- Most Resistant Most Resistant Organism to VHPOrganism to VHP
•• Highly sporicidal even as low as 0.1 mg/lHighly sporicidal even as low as 0.1 mg/l•• Broad kill spectrum Broad kill spectrum •• 35% and 59% H35% and 59% H22OO2 2 Registered EPA Registered EPA
sterilantsterilant•• As per EPA label for 35% Vaprox, short As per EPA label for 35% Vaprox, short
Enveloped, Lipid Viruses Evaluated for Their Resistance
to Hydrogen Peroxide Gas
Advanced Biodecontamination SolutionsWhy VHP? Proven Efficacy Testing with Why VHP? Proven Efficacy Testing with Biological Indicators (BIs) and Chemical Biological Indicators (BIs) and Chemical
When considering VHP typical use concentrations, degradation properties, migratory properties and OSHA exposure limits, VHP offers less exposure risk to personnel and product outside of target decontamination zone where small leaks occur when compared with other gaseous agents.
Advanced Biodecontamination SolutionsWhy VHP? A Green Solution, Why VHP? A Green Solution, EmissionsEmissions
•• No EPA Limit No EPA Limit •• NonNon--toxic byproductstoxic byproducts•• No postNo post--decon wipe downdecon wipe down•• Uniform Fire Code Uniform Fire Code
–– ½½ IDLH emergency conditionsIDLH emergency conditionsfor for ““toxictoxic”” gasesgases
–– Local regulations ? Check.Local regulations ? Check.
Exhaust is rarely if ever an issue. Exhaust is rarely if ever an issue.
Material Compatibility*Material Compatibility*MetalsAluminum Excellent Stainless Steel – all grades Excellent Anodized Aluminum Good Steel Good Brass Good Titanium Excellent Copper Good. Stainless Steel – all grades Excellent Steel Good Titanium Excellent
*Compatibility is defined as the materials ability to undergo exposure to VHP with no significant changes in physical, or chemical properties (i.e. no changes in strength, flexibility, chemical composition, color etc.).
Advanced Biodecontamination Solutions
Materials Deserving Special Consideration
• Nylon• Anodized aluminum (discoloration)
• Copper, galvanized steel, titanium dioxide (may act as catalyst)
Advanced Biodecontamination SolutionsWhy VHP? Why VHP? Material and Component Compatibility Material and Component Compatibility PharmaPharma Project Project
B & V Pilot Field TestB & V Pilot Field Test
••laptop computer (turned on)laptop computer (turned on)••LCD monitor (turned off)LCD monitor (turned off)••telephone (on)telephone (on)••electronic scales (on)electronic scales (on)••various electronic sensors various electronic sensors ••stainless steel clamps, fittings, and connectorsstainless steel clamps, fittings, and connectors••rubber grommets and washersrubber grommets and washers••rubber hosesrubber hoses••plastic funnel and containersplastic funnel and containers
No observed adverse impact following 500%Typical use VHP exposure
Advanced Biodecontamination Solutions
“Corrosion due to the interaction of ClO2and moisture with electronic items contributed to numerous failures during the material demand tests. Corrosion was observed on stainless steel support bars inside the exposure chamber, inside the flow meters, on all metal parts…”
Conc 1,100ppm -2,100ppmSeveral hours
Material Demand Studies: Interaction of Chlorine Dioxide Gas with Building MaterialsOffice of Research and Development
National Homeland Security Research Center / EPA/600/R-08/091 I September 2008 I www.epa.gov/ord
VHP vs. Chlorine Dioxide (CD) gas EPA study
Advanced Biodecontamination Solutions
Material Demand Studies: Interaction of Chlorine Dioxide Gas with Building MaterialsOffice of Research and Development
National Homeland Security Research Center / EPA/600/R-08/091 I September 2008 I www.epa.gov/ord
In compliance with Federal In compliance with Federal Insecticide, Fungicide and Insecticide, Fungicide and Rodenticide Act, all antiRodenticide Act, all anti--microbial microbial agents must be EPA registered. agents must be EPA registered. 35% and 59% hydrogen peroxide 35% and 59% hydrogen peroxide are EPA registered.are EPA registered.
Advanced Biodecontamination Solutions
•• Rapid decontamination at ambient Rapid decontamination at ambient temperatures and low concentrationstemperatures and low concentrations
•• Strong history of use and efficacy data, easily Strong history of use and efficacy data, easily tested with biological indicators (BIs)tested with biological indicators (BIs)
•• Controlled process with realControlled process with real--time time concentration monitoring throughout target concentration monitoring throughout target zonezone
•• Strong comparative safety profileStrong comparative safety profile——detectable detectable well below IDLH, no well below IDLH, no ““trapped gasestrapped gases””
•• NonNon--toxic bytoxic by--productsproducts--a a ““greengreen”” solutionsolution•• No lengthy aerationNo lengthy aeration•• No residueNo residue•• Strong material and component compatibility Strong material and component compatibility
Advanced Biodecontamination SolutionsVHP Generation Technology + Injection•Mobile VHP ARD with circulator and monitoring system
• External or internal injection via network controls with documented cycle parameters
•Solo or daisy chained for larger spaces
• Up to 200,000 ft3 in 24 hours
Advanced Biodecontamination Solutions
VHP Pharmaceutical Facility ApplicationsVHP Pharmaceutical Facility Applications•• Aseptic Manufacturing Rooms and Pilot Production Aseptic Manufacturing Rooms and Pilot Production
Rooms: preRooms: pre--occupancy new or renovated facility, occupancy new or renovated facility, remediation of know contaminant, periodic preventative remediation of know contaminant, periodic preventative
•• Tissue Culture Rooms, Cold Rooms, Warm Rooms Tissue Culture Rooms, Cold Rooms, Warm Rooms Lab Animal Research Procedure, Cage Change and Lab Animal Research Procedure, Cage Change and Equipment Transfer Rooms and HEPA banksEquipment Transfer Rooms and HEPA banks
A2 type biological safety cabinets can be decontaminatedtogether with the room
- Exhaust dampers above cabinets are closed- Cabinet blowers left on
VHP Applications contd. VHP Applications contd.
Advanced Biodecontamination Solutions
VHP Service Project PlanningVHP Service Project Planning•• Fumigation management plan (FMP) Fumigation management plan (FMP)
project document project document •• Define purpose and scope of Define purpose and scope of
decontaminationdecontamination•• Identify the team players including Identify the team players including
stakeholders and support personnel stakeholders and support personnel (area managers and PIs, EH &S, facilities (area managers and PIs, EH &S, facilities engineering, security, etc.) and assign engineering, security, etc.) and assign responsibilitiesresponsibilities
•• Review site schematics, perform site visit, Review site schematics, perform site visit, evaluate HVAC and electrical capabilitiesevaluate HVAC and electrical capabilities
•• Review personnel/authority notification, Review personnel/authority notification, site control and security, site signagesite control and security, site signage
Advanced Biodecontamination Solutions
•• Review area preparation: preReview area preparation: pre--cleaning, cleaning, material/equipment transfer, HVAC material/equipment transfer, HVAC control/support, smoke detector control/support, smoke detector disengagement responsibilities, sealing of disengagement responsibilities, sealing of space space
•• Establish safety buffer zone, project safety Establish safety buffer zone, project safety plan and external monitoring planplan and external monitoring plan
•• Review post decontamination area Review post decontamination area clearance and equipment/material clearance and equipment/material retrieval proceduresretrieval procedures
•• Establish BI locations/mapping Establish BI locations/mapping •• Establish the final project schedule, task Establish the final project schedule, task
sequencing and responsibilitiessequencing and responsibilities
•• Upon arrival to job site equipment, material and personnel Upon arrival to job site equipment, material and personnel transfer commences in accordance with site requirements transfer commences in accordance with site requirements (gowning, equipment transfer protocols)(gowning, equipment transfer protocols)
•• Target area is prepared for decontamination: BI, CI, VHP Target area is prepared for decontamination: BI, CI, VHP generator, fans, network cable, emergency signage generator, fans, network cable, emergency signage placement placement
•• Smoke detectors disengaged/ HVAC isolated Smoke detectors disengaged/ HVAC isolated •• Final preFinal pre--go walkgo walk--thru/assessment with client to confirm thru/assessment with client to confirm
area readinessarea readiness•• Upon client authorization/clearance VHP injection Upon client authorization/clearance VHP injection
commencescommences•• RealReal--time internal and external monitoring of VHPtime internal and external monitoring of VHP•• Following injection commensurate with project Following injection commensurate with project
requirements, aeration commences to bring VHP levels in requirements, aeration commences to bring VHP levels in area to below PEL 1.0 ppmarea to below PEL 1.0 ppm
•• Following area clearance, equipment, and BI/CI retrievalFollowing area clearance, equipment, and BI/CI retrieval•• Upon completion of independent thirdUpon completion of independent third--party BI analysis, party BI analysis,
report issuedreport issued
VHP Project ExecutionVHP Project Execution
Advanced Biodecontamination SolutionsCase Study 1:Case Study 1:Pharmaceutical Manufacturing FacilityPharmaceutical Manufacturing Facility
•• Remote (AHU) and terminal Remote (AHU) and terminal ceiling HEPA filtrationceiling HEPA filtration
•• Internal DaisyInternal Daisy--chained VHP chained VHP injection connected to injection connected to network/laptop for injection network/laptop for injection controlcontrol
Advanced Biodecontamination Solutions
VHP Case Study 1 continuedVHP Case Study 1 continued
•• 56 liters of Vaprox 59% 56 liters of Vaprox 59% •• 95 six95 six--log BIs, 25 CIslog BIs, 25 CIs•• VHP injection 200 g/min via 17 VHP injection 200 g/min via 17
VHP generators for four hoursVHP generators for four hours•• Start Rh 42%, peak Rh 56%Start Rh 42%, peak Rh 56%•• VHP average concentrationVHP average concentration
342 ppm342 ppm
Advanced Biodecontamination Solutions
•• All CIs changed colorAll CIs changed color•• 96% BIs 96% BIs >> sixsix--log kill, with log kill, with
28 rooms,28 rooms, pilot production pilot production facilityfacility
•• Issue: Preventative during Issue: Preventative during shutdownshutdown
•• Remote (AHU) and Remote (AHU) and terminal ceiling HEPA terminal ceiling HEPA filtrationfiltration
•• Internal DaisyInternal Daisy--chained chained VHP injection connected to VHP injection connected to network/laptop for injection network/laptop for injection controlcontrol
Case Study 2: Pharmaceutical Manufacturing FacilityCase Study 2: Pharmaceutical Manufacturing Facility
Advanced Biodecontamination Solutions
VHP Case Study 2 continuedVHP Case Study 2 continued
•• 22 liters of Vaprox 35% 22 liters of Vaprox 35% •• 65 six65 six--log BIs, 18 CIslog BIs, 18 CIs•• VHP injection 108 g/min via 9 VHP injection 108 g/min via 9
VHP generators for five hoursVHP generators for five hours•• Start Rh 46%, peak 62%Start Rh 46%, peak 62%•• VHP average concentrationVHP average concentration
327 ppm327 ppm
Advanced Biodecontamination Solutions
•• All CIs changed colorAll CIs changed color•• 100% BIs six100% BIs six--log killlog kill•• External monitoring VHP External monitoring VHP
concentration < 1.0 ppm concentration < 1.0 ppm throughout safety throughout safety perimeterperimeter
•• No adverse material No adverse material compatibility outcomescompatibility outcomes
•• 24 hours from prep to 24 hours from prep to aeration completionaeration completion
VHP Case Study 2 continuedVHP Case Study 2 continued
Advanced Biodecontamination Solutions
Environmentally SafeEnvironmentally SafeExcellent Material Compatibility, Even with Excellent Material Compatibility, Even with Sensitive Electronics, and Low ToxicitySensitive Electronics, and Low Toxicity
ResidueResidue--FreeFreeQuickly Breaks Down into Water Vapor and Quickly Breaks Down into Water Vapor and Oxygen.Oxygen.
Ideal forIdeal for Cleanrooms Cleanrooms Integrated as a userIntegrated as a user--friendly Utility friendly Utility
Consistency & DistributionWet surfaces / minimal contact times -not an issuePasses through HEPA filtersDecontaminates biosafety cabinets and HEPAs during room decon
Rapidly kills airborne and surface microbes
LaborMinimal labor requiredHundreds of validation applications
Advanced Biodecontamination Solutions
AcknowledgementsAcknowledgements
John Klostermyer and Larry ZankoJohn Klostermyer and Larry ZankoSTERIS CorporationSTERIS Corporation
Advanced Biodecontamination Solutions
Questions and Project DiscussionQuestions and Project Discussion
Contacts: Contacts: Peter Harris Peter Harris [email protected]@bandvtesting.com
Nick Flynn Nick Flynn [email protected]@bandvtesting.com,,800800--851851--90819081