Vaporized Hydrogen Peroxide (VHP Advanced

Advanced Biodecontamination Solutions

Vaporized Hydrogen Peroxide (VHP ®) Advanced Biodecontamination Solutions (ABS) : 'GREEN' Technology for the Highest Level of Microbial Control within a Life Science Facility Prepared by Peter Harris and Nick Flynn B & V TESTING, INC. STERIS-Certified VHP Application Specialists Northeast: 86 West St, Waltham, MA 02451 Mid-Atlantic: 3 Vale Rd, Bel Air, MD 21014 www.bandvtesting.com 800.851.9081


Agenda • Introduction to Advanced Biodecontamination Solutions (ABS), a joint service offering from B & V TESTING, INC. and STERIS Corporation • VHP Background and History • Overview of the VHP Process: efficacy, safety, regulatory landscape, environmental properties and material compatibility • VHP Technology and Equipment • VHP Biodecontamination Field Applications • VHP Services and Project Planning • Case Studies

•


B & V TESTING and STERIS Advanced Biodecontamination Solutions (ABS) • ABS: a Flexible service offering matching the field service expertise of B & V TESTING with STERIS VHP technology and EPA-registered consumables – Contract VHPbiodecontamination services and Spor-Klenz RTU biodecontamination services

National leader in biodecontamination and contamination control technologies testing, certification and maintenance services: – 30 years experience performing gaseous Biodecontamination Services (formaldehyde, VHP, CD) – Testing, Certification and Maintenance of Cleanrooms, Biological Safety Cabinets, and HEPA-filtered systems

•STERIS is a global leader in infection prevention, contamination control, surgical and critical care technologies, and more. Manufacturers of EPA registered Vaprox® 35% and 59% hydrogen peroxide (EPA reg. no. 58779-4), Spor-Klenz (EPA reg. no. 52252-4-1043 and VHP® technology


Why Gaseous Decontamination? • • • • • • •

Contamination remediation Pre-occupancy new or renovated facility Preventative periodic bio-burden reduction Product/population change Equipment transfer Facility decommissioning Equipment maintenance, i.e. BSCs, HEPA housings, etc.


VHP: Background and History • VHP process developed mid-1980s, utilizing patented closed-loop, low concentration “dry” process • VHP process patent issued in early 1990s • Over 1,200 VHP systems in use world-wide in pharma, med device, LAR, bio-containment fields • 15+ years of validated use in pharmaceutical manufacturing • Large scale VHP facility applications applied for remediation during 2001 anthrax attacks • 2006-Present VHP contract service available to industry through ABS STERIS/B & V offering, 150+ Projects


The VHP Process

35% or 59% Hydrogen Peroxide Liquid (Vaprox)

Cold Sterilization Process Vaporization

+

2H2O2 4-80oC

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

2H2O

O2 Non-Toxic Residues

“Typical” VHP Biodecontamination Cycle


100 %

More

Relative Humidity

Less

Decontamination

Condition

0% Dehumidification —target 30-50%

Cycle Phase

Gas Concentration: for room decon typically 150-700 ppm

Relative Humidity

Rh start target: typically 30-50%

Aeration

VHP Concentration

Condensation Point

Vapor or Condensate? STERIS VHP is Advanced Biodecontamination Solutions Boiling Points: a DRY Process 100°C H2O H2O2

150°C

…if you can see it, it’s not a vapor


Variables Affecting Efficacy • Temperature and humidity affect how much hydrogen peroxide (HP) can be generated in the gas state, start Rh typically 30-50% • Concentration—typically 150-700 ppm room applications ¾ (injection rate/ air flow ) * wt. % of HP • Saturation ¾ Inject as much as possible but below dew-point ¾ Humidity is good for microbial kill • Distribution—may be facilitated with fans • Materials which can reduce VHP concentration, cellulosic material (i.e. cardboard, paper), galvanized steel, standing water


Why VHP? EPA-Registered Sterilant Sporicidal at Low Concentrations (toughest kill)

• Bacterial Spores - Most Resistant Organism to VHP • Highly sporicidal even as low as 0.1 mg/l • Broad kill spectrum • 35% and 59% H2O2 Registered EPA sterilant • As per EPA label for 35% Vaprox, short contact times, 6-log reduction: 30 minutes @ 400 ppm 90 minutes @ 250 ppm

Geobacillus stearothermophilu Cross section

Resistance to VHP—Broad Spectrum Sterilant


Bacillus cereus / sphaericus Bacillus subtilis / G. stearothermophilus Clostridium spp

VHP Kill Matrix: Fast D Values


Geobacillus stearothermophilus spores inoculated on Stainless Steel Coupons at 300C


Bacterial Spores Evaluated for Their Resistance to Hydrogen Peroxide Gas • Bacillus anthracis • Bacillus cereus • Bacillus circulans

• Clostridium botulinum • Clostridium sporogenes • Clostridium tetani

• Bacillus pumilus • Clostridium difficile • Geobacillus stearothermophilus • Bacillus subtilus


Mycobacteria Evaluated for Their Resistance to Hydrogen Peroxide Gas • Mycobacterium smegmatis • Mycobacterium terrae • Mycobacterium bovis • Mycobacterium tuberculosis • Nocardia lactamdurans


Non-enveloped, Non-lipid Viruses Evaluated for Their Resistance to Hydrogen Peroxide Gas • Parvoviridae (Feline and Canine parvovirus) • Picornaviridae (Polio Type 1, Swine Vesicular, Rhinovirus 14) • Reoviridae (Blue Tongue, Avian reovirus) • Caliciviridae (Vesicular exanthema)


Gram-negative Vegetative Bacteria Evaluated for Their Resistance to Hydrogen Peroxide Gas • Burkholdia cepacia • Pseudomonas aeruginosa • Serratia marcesens • Escherichia coli • Proteus vulgaris • Salmonella choleraesuis


Fungi, Molds, and Yeasts Evaluated for Their Resistance to Hydrogen Peroxide Gas • Aspergillus niger • Aspergillus terrus • Candida parapsilosis • Rhodotorula glutinis • Fusarium oxysporum • Penicillium chrysogenum

• Candida parapsilosis • Saccharomyces cerevisiae • Rhodotorula glutinis


Large Non-enveloped Viruses Evaluated for Their Resistance to Hydrogen Peroxide Gas • Adenovirus (Adenovirus 2) • Poxviridae (Vaccinia)


Gram-positive Bacteria Evaluated for Their Resistance to Hydrogen Peroxide Gas • • • • • •

Enterococcus faecium Enterococcus faecalis Staphylococcus aureus (MRSA) Lactobacillus casei Listeria monocytogenes Legionella pneumophilia

Enveloped, Lipid Viruses Evaluated for Their Resistance to Hydrogen Peroxide Gas


• Orthomyxoviridae (Avian Influenza) • Paramyxoviridae (New Castle) • Herpesviridae (Pseudorabies, Herpes Simplex) • Rhaboviridae (Vesicular stomatitis) • Toga/Flaviviridae (Hog cholerae, BVD)


Why VHP? Proven Efficacy Testing with Biological Indicators (BIs) and Chemical Indicators (CIs) • Biological Indicators Most VHP-Resistant geobacillus stearothermophilus typically 3-6 log • Chemical Indicators – Qualitative instant feedback

Why VHP? Injection Control and Real-time Monitoring


Why VHP? Favorable Safety Profile Exposure Limits Chlorine Dioxide Severe irritant PEL 0.1 ppm STEL 0.3 ppm IDLH 5.0 ppm

Hydrogen Peroxide Skin/eye irritant PEL 1.0 ppm IDLH 75 ppm


Formaldehyde Human carcinogen PEL 0.75 ppm STEL 2 ppm IDLH 10 ppm

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


Why VHP? Favorable Safety Profile Typical Use Concentrations

Typical Decontamination Concentrations: VHP

Formaldehyde

150-700 ppm

8,000-10,000 ppm 350-1,500 ppm

Chlorine Dioxide

Why VHP? Favorable Safety Profile: Natural Degradation


Time

7:51:59

7:01:21

6:09:37

5:19:00

4:28:22

3:37:45

2:47:08

1:56:31

1:05:54

0:15:16

23:24:39

22:34:02

21:43:25

20:52:48

20:02:10

19:11:33

650 625 600 575 550 525 500 475 450 425 400 375 350 325 300 275 250 225 200 175 150 125 100 75 50 25 0

18:20:56

VHP Sensor 1 PP

From600 ppmto < IDLH 75 ppmin < 2 hours via Natural Degradation; Even faster with aeration


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.

Why VHP? Safety 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.

Why VHP? A Green Solution, Emissions • • • •

No EPA Limit Non-toxic byproducts No post-decon wipe down Uniform Fire Code – ½ IDLH emergency conditions for “toxic” gases – Local regulations ? Check.

Exhaust is rarely if ever an issue. Why? • Dilution • Natural rapid degradation


2H2O

O2

Material Compatibility* Metals Aluminum Excellent Anodized Aluminum Good Brass Good Copper Good. Stainless Steel – all grades Excellent Steel Good Titanium Excellent Plastics ABS Excellent Aflas Excellent CPVC (chlorinated polyvinylchloride) Excellent Kel –F Excellent Nylon Fair PMMA Excellent Polyethersulfone (PES) Excellent PolyethyleneTerephthalate (PET) Good Elastomers Buna N Fair Butyl Rubber Good Chem Raz Good EPDM Fair Viton Excellent


Stainless Steel – all grades Excellent Steel Good Titanium Excellent

Polyacetal (Delrin) Excellent Polycarbonate Excellent Polyetherimide (Ultem) Excellent Polymethylepentene Excellent Polyphenylene oxide Excellent Polyetherketone (PEEK) Excellent Polyethylene (HDPE, LDPE UHMWPE) Excellent

Hypalon Polyurethane Silicone Rubbers Kelrez

Excellent Excellent Excellent 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

Why VHP? Advanced Biodecontamination Solutions Material and Component Compatibility Pharma Project B & V Pilot Field Test •laptop computer (turned on) •LCD monitor (turned off) •telephone (on) •electronic scales (on) •various electronic sensors •stainless steel clamps, fittings, and connectors •rubber grommets and washers •rubber hoses •plastic funnel and containers

No observed adverse impact following 500% Typical use VHP exposure

VHP vs. Chlorine Dioxide (CD) gas EPA study


“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…”

Material Demand Studies: Interaction of Chlorine Dioxide Gas with Building Materials Office of Research and Development National Homeland Security Research Center / EPA/600/R-08/091 I September 2008 I www.epa.gov/ord

Conc 1,100ppm -2,100ppm Several hours

CD gas EPA study

Material Demand Studies: Interaction of Chlorine Dioxide Gas with Building Materials Office of Research and Development National Homeland Security Research Center / EPA/600/R-08/091 I September 2008 I www.epa.gov/ord


1,100-2,100ppm Several hours


Why VHP? EPA-registered, FIFRA compliant In compliance with Federal Insecticide, Fungicide and Rodenticide Act, all anti-microbial agents must be EPA registered. 35% and 59% hydrogen peroxide are EPA registered.

Why VHP? A Summary of Advantages


• Rapid decontamination at ambient temperatures and low concentrations • Strong history of use and efficacy data, easily tested with biological indicators (BIs) • Controlled process with real-time concentration monitoring throughout target zone • Strong comparative safety profile—detectable well below IDLH, no “trapped gases” • Non-toxic by-products-a “green” solution • No lengthy aeration • No residue • Strong material and component compatibility profile • EPA Registered—FIFRA compliant


VHP 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 Applications • Aseptic Manufacturing Rooms and Pilot Production Rooms: pre-occupancy new or renovated facility, remediation of know contaminant, periodic preventative • Tissue Culture Rooms, Cold Rooms, Warm Rooms Lab Animal Research Procedure, Cage Change and Equipment Transfer Rooms and HEPA banks • Biocontainment Labs/Suites, BSL3, BSL4 • Biological Safety Cabinets, Incubators, Enclosures

VHP Applications contd. Simultaneous Decon of Primary Containment A2 type biological safety cabinets can be decontaminated together with the room - Exhaust dampers above cabinets are closed - Cabinet blowers left on


VHP Service Project Planning • Fumigation management plan (FMP) project document • Define purpose and scope of decontamination • Identify the team players including stakeholders and support personnel (area managers and PIs, EH &S, facilities engineering, security, etc.) and assign responsibilities • Review site schematics, perform site visit, evaluate HVAC and electrical capabilities • Review personnel/authority notification, site control and security, site signage



VHP Project Planning contd. • Review area preparation: pre-cleaning, material/equipment transfer, HVAC control/support, smoke detector disengagement responsibilities, sealing of space • Establish safety buffer zone, project safety plan and external monitoring plan • Review post decontamination area clearance and equipment/material retrieval procedures • Establish BI locations/mapping • Establish the final project schedule, task sequencing and responsibilities

VHP Project Execution


• Upon arrival to job site equipment, material and personnel transfer commences in accordance with site requirements (gowning, equipment transfer protocols) • Target area is prepared for decontamination: BI, CI, VHP generator, fans, network cable, emergency signage placement • Smoke detectors disengaged/ HVAC isolated • Final pre-go walk-thru/assessment with client to confirm area readiness • Upon client authorization/clearance VHP injection commences • Real-time internal and external monitoring of VHP • Following injection commensurate with project requirements, aeration commences to bring VHP levels in area to below PEL 1.0 ppm • Following area clearance, equipment, and BI/CI retrieval • Upon completion of independent third-party BI analysis, report issued

Case Study 1:


Pharmaceutical Manufacturing Facility • Project scope: 160,000 ft3 42 rooms, manufacturing space including bioreactor rooms • Issue: bacterial remediation emergency • Remote (AHU) and terminal ceiling HEPA filtration • Internal Daisy-chained VHP injection connected to network/laptop for injection control


VHP Case Study 1 continued

• 56 liters of Vaprox 59% • 95 six-log BIs, 25 CIs • VHP injection 200 g/min via 17 VHP generators for four hours • Start Rh 42%, peak Rh 56% • VHP average concentration 342 ppm


VHP Case Study 1 continued • All CIs changed color • 96% BIs > six-log kill, with remaining > five-log kill (log reduction analysis) • External monitoring VHP concentration < 1.0 ppm throughout safety perimeter • No adverse material compatibility outcomes • 24 hours from prep to aeration completion


Case Study 2: Pharmaceutical Manufacturing Facility • Project Scope: 84,000 ft3 28 rooms, pilot production facility • Issue: Preventative during shutdown • Remote (AHU) and terminal ceiling HEPA filtration • Internal Daisy-chained VHP injection connected to network/laptop for injection control


VHP Case Study 2 continued • • •

22 liters of Vaprox 35% 65 six-log BIs, 18 CIs VHP injection 108 g/min via 9 VHP generators for five hours • Start Rh 46%, peak 62% • VHP average concentration 327 ppm


VHP Case Study 2 continued • • •

All CIs changed color 100% BIs six-log kill External monitoring VHP concentration < 1.0 ppm throughout safety perimeter • No adverse material compatibility outcomes • 24 hours from prep to aeration completion


Why VHP?

¾ Environmentally Safe 9 Excellent Material Compatibility, Even with Sensitive Electronics, and Low Toxicity

¾ Residue-Free 9 Quickly Breaks Down into Water Vapor and Oxygen.

¾ Ideal for Cleanrooms 9 Integrated as a user-friendly Utility

¾ Use Registered with EPA

VHP® Technology For a greener world

Why VHP? 9 Consistency & Distribution ¾ Wet surfaces / minimal contact times -not an issue ¾ Passes through HEPA filters ¾ Decontaminates biosafety cabinets and HEPAs during room decon ¾ Rapidly kills airborne and surface microbes 9 Labor ¾ Minimal labor required ¾ Hundreds of validation applications



Acknowledgements John Klostermyer and Larry Zanko STERIS Corporation


Questions and Project Discussion Contacts: Peter Harris [email protected] Nick Flynn [email protected], 800-851-9081 www.bandvtesting.com www.steris.com

Vaporized Hydrogen Peroxide (VHP Advanced

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