Vaporized Hydrogen Peroxide (VHP ®) Advanced

Transcription

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
• Burkholdia cepacia
• Pseudomonas
aeruginosa
• Serratia marcesens
• Escherichia coli
• Proteus vulgaris
• Salmonella choleraesuis
Fungi, Molds, and Yeasts
• Aspergillus niger
• Aspergillus terrus
• Candida parapsilosis
• Rhodotorula glutinis
• Fusarium oxysporum
• Penicillium chrysogenum
• Candida parapsilosis
• Saccharomyces
cerevisiae
• Rhodotorula glutinis
Large Non-enveloped Viruses
• Adenovirus (Adenovirus 2)
• Poxviridae (Vaccinia)
Gram-positive Bacteria
•
•
•
•
•
•
Enterococcus faecium
Enterococcus faecalis
Staphylococcus aureus (MRSA)
Lactobacillus casei
Listeria monocytogenes
Legionella pneumophilia
Enveloped, Lipid Viruses
• 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?
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
• 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
•
•
•
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
•
•
•
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 peter@bandvtesting.com
Nick Flynn nick.flynn@bandvtesting.com,
800-851-9081
www.bandvtesting.com
www.steris.com

Vaporized Hydrogen Peroxide (VHP ®) Advanced

Transcription

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