Vaporized Hydrogen Peroxide (VHP Advanced Biodecontamination

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 FacilityMicrobial Control within a Life Science Facility

Prepared by Prepared by Peter Harris and Nick FlynnPeter Harris and Nick Flynn

B & V TESTING, INC.B & V TESTING, INC.STERISSTERIS--Certified VHP Application SpecialistsCertified VHP Application Specialists

Northeast: 86 West St, Waltham, MA 02451Northeast: 86 West St, Waltham, MA 02451MidMid--Atlantic: 3 Vale Rd, Bel Air, MD 21014Atlantic: 3 Vale Rd, Bel Air, MD 21014

www.bandvtesting.comwww.bandvtesting.com800.851.9081800.851.9081


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


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

biodecontamination servicesbiodecontamination services

•• 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

Biodecontamination ServicesBiodecontamination Services(formaldehyde, VHP, CD)(formaldehyde, VHP, CD)

–– 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


Why Gaseous Decontamination? Why Gaseous Decontamination?

•• 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.


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


The VHP ProcessThe VHP Process

2H2O2

2H2O

O2

+

Sporicidal at LowConcentrations

(Typically .5-1 mg/l at 25oC)

Cold Sterilization

Process

4-80oC

Non-ToxicResidues

Vaporization35% or 59%

Hydrogen Peroxide Liquid

(Vaprox)

Advanced Biodecontamination Solutions““TypicalTypical”” VHPVHPBiodecontamination CycleBiodecontamination Cycle

Deh

umid

ifica

tion

—ta

rget

30-

50%

Con

ditio

n

Dec

onta

min

atio

n

Aer

ati o

n

100 %

VH

P C

once

ntra

tion

More

Less0 %

Rel

ativ

eH

umid

ity

CyclePhase

Gas Concentration: for roomdecon typically 150-700 ppm

Relative Humidity

Condensation Point

Rh start target: typically 30-50%


…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


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


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

contact times, 6contact times, 6--log reduction: log reduction: 30 minutes @ 400 ppm 30 minutes @ 400 ppm 90 minutes @ 250 ppm90 minutes @ 250 ppm

Geobacillus stearothermophiluCross section


Resistance to VHP—Broad Spectrum Sterilant

Bacillus cereus / sphaericus

Bacillus subtilis / G. stearothermophilus

Clostridium spp


Geobacillus stearothermophilus spores inoculated onStainless Steel Coupons at 300C

VHP Kill Matrix: Fast D Values


•• Bacillus Bacillus anthracisanthracis

•• Bacillus cereusBacillus cereus

•• Bacillus Bacillus circulanscirculans

•• Bacillus Bacillus pumiluspumilus

•• Geobacillus stearothermophilusGeobacillus stearothermophilus

•• Bacillus Bacillus subtilussubtilus

•• Clostridium botulinumClostridium botulinum

•• Clostridium sporogenesClostridium sporogenes

•• Clostridium tetaniClostridium tetani

•• Clostridium difficileClostridium difficile

Bacterial Spores Evaluated for Their Resistance to Hydrogen Peroxide Gas


Mycobacteria Evaluated for Their Mycobacteria Evaluated for Their Resistance to Hydrogen Peroxide GasResistance to Hydrogen Peroxide Gas

•• Mycobacterium smegmatisMycobacterium smegmatis

•• Mycobacterium terraeMycobacterium terrae

•• Mycobacterium bovisMycobacterium bovis

•• Mycobacterium tuberculosisMycobacterium tuberculosis

•• Nocardia lactamduransNocardia lactamdurans


NonNon--enveloped, Nonenveloped, Non--lipid Viruses lipid Viruses Evaluated for Their Resistance Evaluated for Their Resistance

to Hydrogen Peroxide Gasto Hydrogen Peroxide Gas•• Parvoviridae (Feline and Canine parvovirus)Parvoviridae (Feline and Canine parvovirus)

•• Picornaviridae (Polio Type 1, Swine Vesicular, Rhinovirus 14)Picornaviridae (Polio Type 1, Swine Vesicular, Rhinovirus 14)

•• Reoviridae (Blue Tongue, Avian reovirus)Reoviridae (Blue Tongue, Avian reovirus)

•• Caliciviridae (Vesicular exanthema)Caliciviridae (Vesicular exanthema)


Gram-negative Vegetative Bacteria Evaluated for Their Resistance

to Hydrogen Peroxide Gas

•• Burkholdia cepaciaBurkholdia cepacia•• Pseudomonas Pseudomonas

aeruginosaaeruginosa•• Serratia marcesensSerratia marcesens•• Escherichia coliEscherichia coli•• Proteus vulgarisProteus vulgaris•• Salmonella choleraesuisSalmonella choleraesuis


Fungi, Molds, and Yeasts Fungi, Molds, and Yeasts Evaluated for Their ResistanceEvaluated for Their Resistance

to Hydrogen Peroxide Gasto Hydrogen Peroxide Gas•• Aspergillus nigerAspergillus niger

•• Aspergillus terrusAspergillus terrus

•• Candida parapsilosisCandida parapsilosis

•• Rhodotorula glutinisRhodotorula glutinis

•• Fusarium oxysporumFusarium oxysporum

•• Penicillium chrysogenumPenicillium chrysogenum

•• Candida parapsilosisCandida parapsilosis•• Saccharomyces Saccharomyces

cerevisiaecerevisiae•• Rhodotorula glutinisRhodotorula glutinis


Large NonLarge Non--enveloped Virusesenveloped VirusesEvaluated for Their Resistance Evaluated for Their Resistance

to Hydrogen Peroxide Gasto Hydrogen Peroxide Gas•• Adenovirus (Adenovirus 2)Adenovirus (Adenovirus 2)

•• Poxviridae (Vaccinia)Poxviridae (Vaccinia)


GramGram--positive Bacteria positive Bacteria Evaluated for Their Resistance Evaluated for Their Resistance

to Hydrogen Peroxide Gasto Hydrogen Peroxide Gas•• Enterococcus faeciumEnterococcus faecium•• Enterococcus faecalisEnterococcus faecalis•• Staphylococcus aureus Staphylococcus aureus (MRSA)(MRSA)•• Lactobacillus caseiLactobacillus casei•• Listeria monocytogenesListeria monocytogenes•• Legionella pneumophiliaLegionella pneumophilia


•• Orthomyxoviridae (Avian Influenza)Orthomyxoviridae (Avian Influenza)

•• Paramyxoviridae (New Castle)Paramyxoviridae (New Castle)

•• Herpesviridae (Pseudorabies, Herpes Herpesviridae (Pseudorabies, Herpes

Simplex)Simplex)

•• Rhaboviridae (Vesicular stomatitis)Rhaboviridae (Vesicular stomatitis)

•• Toga/Flaviviridae (Hog cholerae, BVD)Toga/Flaviviridae (Hog cholerae, BVD)

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

Indicators (CIs)Indicators (CIs)

•• Biological Indicators Biological Indicators --Most VHPMost VHP--Resistant Resistant geobacillus geobacillus stearothermophilusstearothermophilustypically 3typically 3--6 log6 log

•• Chemical Indicators Chemical Indicators ––Qualitative instant Qualitative instant feedbackfeedback

Advanced Biodecontamination SolutionsWhy VHP? Injection Control and Why VHP? Injection Control and RealReal--time Monitoringtime Monitoring

Advanced Biodecontamination SolutionsWhy VHP? Why VHP? Favorable Safety ProfileFavorable Safety Profile

Exposure Limits Exposure Limits

Chlorine DioxideChlorine Dioxide

Severe irritantSevere irritantPEL 0.1 ppmPEL 0.1 ppmSTEL 0.3 ppmSTEL 0.3 ppmIDLH 5.0 ppmIDLH 5.0 ppm

FormaldehydeFormaldehyde

Human carcinogenHuman carcinogenPEL 0.75 ppmPEL 0.75 ppmSTEL 2 ppmSTEL 2 ppmIDLH 10 ppmIDLH 10 ppm

Hydrogen Hydrogen PeroxidePeroxide

Skin/eye irritantSkin/eye irritantPEL 1.0 ppmPEL 1.0 ppmIDLH 75 ppmIDLH 75 ppm

PEL - Permissible Exposure Limit (8 hours)STEL - Short-term Exposure Limit (15 min.)IDLH - Immediately Dangerous to Life or Health


Why VHP? Why VHP? Favorable Safety ProfileFavorable Safety Profile

Typical Use ConcentrationsTypical Use Concentrations

Chlorine DioxideChlorine Dioxide

350350--1,500 ppm1,500 ppm

FormaldehydeFormaldehyde

8,0008,000--10,000 ppm10,000 ppm

VHPVHP

150150--700 ppm700 ppm

Typical Decontamination Concentrations:

Advanced Biodecontamination SolutionsWhy VHP? Why VHP?

Favorable Safety Profile: Natural DegradationFavorable Safety Profile: Natural DegradationFrom 600 ppm to < IDLH 75 ppm in < 2 hours via Natural

Degradation; Even faster with aeration

0255075

100125150175200225250275300325350375400425450475500525550575600625650

18:2

0:56

19:1

1:33

20:0

2:10

20:5

2:48

21:4

3:25

22:3

4:02

23:2

4:39

0:15

:16

1:05

:54

1:56

:31

2:47

:08

3:37

:45

4:28

:22

5:19

:00

6:09

:37

7:01

:21

7:51

:59

Time

VHP

Sens

or 1

PP


VHP Safety Buffer Zones: Case Study

Pharma BSL2 TC Lab 1,500 ft3

Drop Ceiling, Open Wall Plenum to Adjacent Lab, Unsealed Penetrations


VHP Safety Buffer Zones: Case Study contd.

Advanced Biodecontamination SolutionsWhy VHP? Why VHP? Safety ProfileSafety Profile

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.

Why?Why?•• DilutionDilution•• Natural rapid degradationNatural rapid degradation

2H2O O2


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

Plastics ABS Excellent Polyacetal (Delrin) Excellent Aflas Excellent Polycarbonate Excellent CPVC (chlorinated polyvinylchloride) Excellent Polyetherimide (Ultem) Excellent Kel –F Excellent Polymethylepentene Excellent Nylon Fair Polyphenylene oxide Excellent PMMA Excellent Polyetherketone (PEEK) Excellent Polyethersulfone (PES) Excellent Polyethylene (HDPE, LDPE UHMWPE) Excellent PolyethyleneTerephthalate (PET) Good ElastomersBuna N Fair Hypalon ExcellentButyl Rubber Good Polyurethane ExcellentChem Raz Good Silicone Rubbers ExcellentEPDM Fair Kelrez ExcellentViton 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.).


Materials Deserving Special Consideration

• Nylon• Anodized aluminum (discoloration)

• Copper, galvanized steel, titanium dioxide (may act as catalyst)

• Latex Gloves• Freshly painted and/or improperly cured

surfaces

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


“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


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

1,100-2,100ppmSeveral hours

CD gas EPA study


Why VHP? Why VHP? EPAEPA--registered, FIFRA compliantregistered, FIFRA compliant

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.


•• 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

profileprofile•• EPA RegisteredEPA Registered——FIFRA compliantFIFRA compliant

Why VHP? A Summary of Advantages

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


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

•• Biocontainment Labs/Suites, BSL3, BSL4Biocontainment Labs/Suites, BSL3, BSL4•• Biological Safety Cabinets, Incubators, EnclosuresBiological Safety Cabinets, Incubators, Enclosures


Simultaneous Deconof Primary Containment

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.


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


•• 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

VHP Project Planning contd.VHP Project Planning contd.


•• 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

•• Project scope: 160,000 Project scope: 160,000 ftft33

42 rooms, manufacturing space 42 rooms, manufacturing space including bioreactor roomsincluding bioreactor rooms

•• Issue: bacterial remediation Issue: bacterial remediation emergencyemergency

•• 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


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


•• All CIs changed colorAll CIs changed color•• 96% BIs 96% BIs >> sixsix--log kill, with log kill, with

remaining remaining >> fivefive--log kill log kill (log reduction analysis)(log reduction analysis)

•• 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



•• Project Scope: 84,000 Project Scope: 84,000 ftft3 3

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



•• 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


•• 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



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

Use Registered with EPAUse Registered with EPA

VHPVHP®® TechnologyTechnology

For a greener worldFor a greener world

Why VHP?

Advanced Biodecontamination SolutionsWhy VHP?Why VHP?

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


AcknowledgementsAcknowledgements

John Klostermyer and Larry ZankoJohn Klostermyer and Larry ZankoSTERIS CorporationSTERIS Corporation


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

www.bandvtesting.comwww.bandvtesting.comwww.steris.comwww.steris.com

Documents

Vaporized Hydrogen Peroxide (VHP Advanced Biodecontamination