ClorDiSys Solutions, Inc.

Chlorine Dioxide Workshop Presentation

NEWS: CD is now NSF approved for BSC Decontamination

Mark A. Czarneski Director of Technology

Overview
1. When, Where, Why ? 2. Define Chlorine Dioxide

Worlds Largest Supplier of Gaseous Chlorine Dioxide Decontamination Equipment and Services

3. Comparisons (CD vs. others) 4. Define Chlorine Dioxide Sterilization Parameters

5. CSI Chlorine Dioxide Generation Equipment

6. Exploration of Applications

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Revision Date: June 22, 2008

What Industries Should be Interested in Chlorine Dioxide

Food Pharmaceutical Healthcare Life Science

Why should there be interest in Food Facility Decontamination?

1. Estimate of the immediate economic losses by the spinach industry due to E. Coli contamination of spinach in 2006 [GAO; Last Accessed 3.17.10]: $37 to $74 Million 2. Estimated cost to the nations peanut producers from the 2009 salmonella contamination of peanut butter [Associated Press; Last Accessed 3.17.10]: $1 Billion 3. Estimated cost to Floridas tomato industry due to a mistaken salmonella finding in 2007 [Sarasota Herald Tribune; Last Accessed 3.17.10]: $500 Million 4. each year roughly 1 out of 6 Americans (or 48 million people) gets sick, 128,000 are hospitalized, and 3,000 die from foodborne diseases. http://www.homefoodsafety.org/pages/media/safety_facts.jsp 5. Foodborne illnesses cost an estimated $152 billion each year in healthrelated expenses.

How does a facility get contaminated? How does your product get contaminated?

Contamination can occur at any step in the processduring production, processing, distribution, transportation, preparation, etc.
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Scharff, R.L., 2010. Health Related Costs from foodborne illness in the United States. Produce safety project at Georgetown University. Accessed at: http:// www.producesafetyproject.org /admin/assets/files/Health-Related-Foodborne-Illness-Costs4 Report.pdf-1.pdf. Accessed on: 05/13/2010.

Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA) was signed into law January, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing Effective July 2011 The first rule of this Act strengthens FDAs ability to prevent potentially unsafe food from entering commerce. It allows the FDA to administratively detain food the agency believes has been produced under insanitary or unsafe conditions. Previously, the FDAs ability to detain food products applied only when the agency had credible evidence that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals.
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm253983.htm
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Why should there be interest in Healthcare Decontamination?

Did you know? In 2002, the estimated number of HAIs (hospital acquired infections) in U.S. hospitals was approximately 1.7 million The estimated deaths associated with HAIs in U.S. hospitals were 98,987: of these, 35,967 were for pneumonia, 30,665 for bloodstream infections, 13,088 for urinary tract infections, 8,205 for surgical site infections, and 11,062 for infections of other sites.

Estimating Health Care-Associated Infections and Deaths in U.S. Hospitals, 2002 http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf
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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Why should there be interest in Life Science Decontamination?

Did you know? Contamination can stall or impede long term research projects costing time and money Contamination can add unwanted variables to studies For Example a contamination at a facility had a total loss to the institution of $4.12 million. This included the cost of the clean up, loss in revenue, salary payments since there were no layoffs or salary cutbacks during the three moths closes.
Dallap Schaer BL, Aceto H, Rankin SC, Outbreak of salmonellosis caused by Salmonella enterica serovar Newport MDR-AmpC in a large animal veterinary teaching hospital, J Vet Intern Med. 2010 7 Sep-Oct;24(5):1138-46. doi: 10.1111/j.1939-1676.2010.0546.x. Epub 2010 Jun 24.

Why should there be interest in Pharmaceutical Decontamination?

Did you know? Contamination can stall or impede production costing time and money Contamination can lead to product recalls, bad publicity, lower stock prices and huge costs ...... Genzyme Issues Stock analysts estimate the contamination and production closure will cost Genzyme between $200 to $300 million in lost revenue. http://cleanroom.net/?p=612

When To Use Chlorine Dioxide Gas

Renovation Between Population / Production Batches Commission De-Commissioning Contamination Preventative Maintenance ..

Where To Use Chlorine Dioxide Gas

Procedure / holding rooms Aseptic / clean rooms Surgical suites Pass throughs Necropsy rooms BSL-1/2/3/4 Cold rooms Isolators BSCs (A1/A2, B1/B2, Class III) HEPA Housings / Duct work Silos / Dryers Buildings / facilities Processing piping Processing tanks and vessels .. Any enclosed space needing decontamination

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Chlorine Dioxide, NSF and BSCs

Chlorine Dioxide Gas has been approved by NSF International under Annex G of NSF/ANSI 49 for the decontamination of BSCs
Only 2 methods are approved for BSC decontamination
1983 Formaldehyde was approved (Contact time 6 h, preferably 12 h) 2008 Chlorine dioxide gas was approved. (Contact time 85 minutes)

Why Use Chlorine Dioxide Gas

Safest fumigant available Fastest cycle times (start to finish) Most complete Penetration and Distribution Most Flexible Process Sterilant process Easy installation (New or Old facility) Good Material Compatibility
Both gases (VHP and CD) are effective against biological agents and residual chemical agents, but destruction of some chemical agents is slow.

NO other method approved for BSC decontamination NOTE: Vapor Phase Hydrogen Peroxide is NOT NSF approved
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Chlorine dioxide was identified as the best available fumigant for decontaminating parts of the Hart Senate Office Building, as
well as for fumigating mail and packages (1) [Science Nov 2003]
1. J. Patrick Fitch, Ellen Raber, Dennis R. Imbro1, Technology Challenges in Responding to Biological or 12 Chemical Attacks in the Civilian Sector SCIENCE VOL 302 #21 NOVEMBER 2003 pp1350-1354.

ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

What is Chlorine Dioxide (CD) ?

Gas

Properties: Yellow-Green Gas1 Water Soluble2 Boiling Point 11oC3 Tri-atomic Molecule Molecular Weight 67.5 1. Ability to be monitored in real time with a photometric device. Not subject to condensation or affected by temperature gradients. 2. Ability to penetrate water (not all sterilants can penetrate water, vapors can not) 3. Chlorine dioxide is a true gas at room temperatures; which means excellent distribution and penetration.
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70o F (21oC) Room Temp 52oF (11oC) Boiling Point

www.Chem4kids.com

Chlorine Dioxide

Liquid

0oF (-17oC)

-40oF (-40oC)

Solid

-74oF (-59o C) Freezing/Melting Point

Chlorine Dioxide Time Line

Aqueous Germicide (Water Treatment Longest User) 1920 Time Chlorine Dioxide Recognized as a Gaseous Chemosterilizing Agent 1984 CSI CD-Cartridge Registered with US-EPA Mar 2004

Types Antimicrobial Pesticides

Sterilizers (Sporicides): Used to destroy or eliminate all forms of microbial life including fungi, viruses, and all forms of bacteria and their spores. Spores are considered to be the most difficult form of microorganism to destroy. Therefore, EPA considers the term Sporicide to be synonymous with "Sterilizer." Disinfectants: Used on hard inanimate surfaces and objects to destroy or irreversibly inactivate infectious fungi and bacteria but NOT necessarily their spores. Disinfectant products are divided into two major types: hospital and general use. Sanitizers: Used to reduce, but not necessarily eliminate, microorganisms from the inanimate environment to levels considered safe as determined by public health codes or regulations. Antiseptics and Germicides: Used to prevent infection and decay by inhibiting the growth of microorganisms. Because these products are used in or on living humans or animals, they are considered drugs and are thus approved and regulated by the Food and Drug Administration (FDA).
http://www.epa.gov/oppad001/ad_info.htm
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1811 First Preparation of Chlorine Dioxide

1940 Bleaching Agent (Pulp & Paper Industry Largest User)

1988 First Registered with the US-EPA for use as a sterilant

World wide consumption of chlorine dioxide 4.5 million lbs/day (2.04million kg/day). 743,000 lbs (337,000 kg) released to atmosphere in 2000. Example: Maine allows 3 lbs / hour (1.4kg / hour)of CD to be emitted

Current Sterilizer (Sporicides) Registration with US-EPA as of January 2009

More than 5000 antimicrobial products are currently registered with the US-EPA. Only 40 agents are registered as a Sterilant. Agent Ethylene Oxide Sodium Chlorite (chlorine dioxide) Hydrogen Peroxide Based Total Quantity 24 4 12 40

Current Sodium Chlorite (Chlorine Dioxide) Sterilizer Registration

Company Alcide Corp ClorDiSys Solutions, Inc. Englehard Corp Produce Name Alcide Exspor 4:1:1 Base CSI CD Cartridge Aseptrol S10Tab CLIDOX-S BASE Registration # 1677-216 80802-1 70060-19 Ingredient % 1.520% 72.8% 20.8% Sterilization Use Immerse in solution for 10 hours @ 20 deg C Follow System Operations Guide Immerse or soak in 1000 ppm solution for min 1 hour 1:3:1 Dilution for 5 hours @ 25 deg C

Pharmacal Research Laboratories Inc

8714-8

0.85%

http://www.epa.gov/oppad001/chemregindex.htm
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For Anthrax cleanup Under Section 18 of FIFRA, EPA exempted Sabre Technologies from any provision of EPA registration requirement for sale or use.
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http://www.epa.gov/oppad001/chemregindex.htm

ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Decontamination Methods
1. Spray and Wipe / Fogging 2. Ethylene Oxide Gas 3. Vapor Phase Hydrogen Peroxide 4. Ozone Gas 5. Formaldehyde Gas 6. Liquid Chlorine Dioxide 7. Chlorine Dioxide Gas

What is an Effective Decontamination?

All Decontamination methods can work based on the following: Must reach ALL surfaces for a prescribed amount of time, which means you must have: 1. Good and Complete Distribution 2. Thorough and Total Penetration 3. Sufficient Contact Time 4. At specified concentration Any decontamination method requires a complete and thorough distribution of the sterilant or high level liquid disinfectant to get an effective decontamination

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Manual Spray / Wipe / Mop

Using a high level liquid disinfectant manual spray and wipe all surfaces Decontaminating agent must be chosen based on level of decontamination required (germicide, sanitizer, disinfectant, sterilant) Requires keeping the surface wet or submersed per EPA approved label requirements
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Manual Spray / Wipe / Mop

Pros Low cost Minimal Equipment (buckets, spray bottles, mops) Easy job Cons Difficult job Hard to reach all surfaces Under side of components Behind equipment Ceilings Ventilation grills Intricate components
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Fogging
Using a high level liquid disinfectant the fogger sprays droplets around the room Decontaminating agent must be chosen based on level of decontamination required (germicide, sanitizer, disinfectant, sterilant) Requires keeping the surface wet or submersed per EPA approved label requirements Foggers create small droplets (5-100 microns) Ionized hydrogen peroxide (7.5%) foggers create positively charge particles
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Fogging
Various Foggers Pros Person removed from the process (Safety) Low cost consumables Low cost equipment Minimal Equipment ($300 fogger + consumables) Cons Not totally effective RH can exceed 90% No concentration monitoring Hard to reach all surfaces (> 5 microns) Bacteria sizes 1-2 microns Under side of components Behind equipment, Ceilings, Ventilation grills, etc. Particles affected by gravity
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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Ionized HP Fogging
Pros Person removed from the process (Safety) Low cost consumables Lower HP concentration (7.5%) compared to VPHP [oxidation] Cons Not totally effective RH can exceed 90% No accurate concentration monitoring Hard to reach all surfaces (> 5 microns) Bacteria sizes 1-2 microns Under side of components Behind equipment, Ceilings, Ventilation grills, etc. Particles affected by gravity Ionized positive charged particles repelled by positively charged materials (glass, aluminum, and air)
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Iodophor
An Iodophor is a preparation containing iodine with a solubilizing agent, such as a surfactant. The result is a water-soluble material that releases free iodine when in solution. Provides sanitization levels Iodophors are typically stored in a processing tank which eliminates a tank from use

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Iodophor
Pros Low cost No residues - when used in proper proportions it evaporates directly from solution to gas, and hence leaves no residues Cons Leaves unattractive orange-brown stains on plastic parts and equipment that it is left in contact with Only used for storage tanks and process piping Eliminates a tank from use

Formaldehyde Gas
Easy process: measure out 0.3g of paraformaldehyde per cubic foot of volume (NSF 49 Annex G) Heat up Paraformaldehyde in hot plate (4500F) to release gas Scalable (just add more hot plates 1000cu ft / hot plate) True Gas (boiling point -19oC) Requires RH 65+% Long Contact times (6-12 hours) Requires high concentrations to achieve sporicidal effects (8000-10,000 ppm) At the end of exposure neutralization is done using ammonia bicarbonate (10% more than the paraformaldehyde used). CERTEK's Model #1414RH
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Formaldehyde Gas
Pros Person removed from the process (Safety) Electric Frying Pan Low cost consumables Low cost equipment (electric frying pan) Simple process (0.3g / cu ft) Penetrates HEPA filters True gas at room temperatures (boiling point -19oC) Non corrosive NSF Approved for BSC cabinets Cons Carcinogen (IARC*) Creates residues (post exposure cleanup required) Formaldehyde falls out upon contact with cold surfaces Large space decontamination is troublesome due to cleanup required, can all surfaces be realistically wiped to remove all residues Not US-EPA registered process
*As of June 2004 the International Agency for Research on Cancer classified formaldehyde as carcinogenic to humans, Retrieved June 30, 2004, from: 29 http://www.iarc.fr/ENG/Press_Releases/archives/pr153a.html

Ozone Gas
Easy process, place generator in room and start the process True Gas (boiling point -112oC) Requires high RH 80-95% Generated by 3 technologies UV lamp generation ( ~ 185 nanometers ) Lower concentration output (1-3 ug/ml) Corona discharge units Higher concentration output (up to 120 ug/ml) Cold Plasma Medium concentration output (up to 70 ug/ml)
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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Ozone Gas
Pros Person removed from the process (Safety) True Gas at room temperatures (boiling point -112oC) Low cost equipment No post exposure cleanup required Cons Generators do not generate enough for room decontamination (used mainly for odor control) Ozone is extremely volatile with short life span (20-30 min) Limited efficacy1 Long cycle time (up to 36 hours) Requires high RH 80%-95% Issues with large volume (getting concentration to all areas due to short life span. Corrosive ( high oxidation potential 2.07) Not US-EPA registered process Not NSF approved for BSC cabinets
1 Foarde, Karin and Eaton, Cary, Ph.D. Ozone Antimicrobial Efficacy EPA/600/R-08-137, Dec 2007 http://www.epa.gov/nrmrl/pubs/600r08137/600r08137.pdf 6 hours exposure 1000ppm 4.3log reduction of spores with high RH >80% 31

Ethylene Oxide Gas (EtO)

Automated process True Gas (boiling point +10.7oC) Requires RH 65+% Injected into a SS chamber Process is run under vacuum High concentrations Used in most hospitals

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Ethylene Oxide Gas (EtO)

Pros Low cost consumables Penetrates HEPA filters True gas at room temperatures (boiling point +10.7oC) Non corrosive Excellent penetration Cons Carcinogen (IARC*) Explosive Required Damage Limiting Construction (DLC) Excellent penetration Long aeration times
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Vapor Phase Hydrogen Peroxide (VPHP)

Easy process: place generator either outside or inside the room Heat up liquid HP to boiling point (+109oC) and inject into room Must insulate or heat trace injection hoses to maximize concentration delivered to the chamber 1 Generator for approximately 2000-10,000 cu ft. Currently 2 camps of thought for VPHP, Wet and Dry Dry process - Must constantly inject vapor due to condensation which causes concentration drop in room Wet process - Inject fixed amount of HP then stop, allow to condense RH exceeds 85% during process Non - Flammable Medium cycle times (rooms 6-12 hours) Short contact times (1-2 hours) 34 Low concentrations (700-1500ppm)

Chlorine Dioxide

Hydrogen Peroxide (35%)

Gas
Optimal State for Sterilization

VPHP Condensation
Currently 2 camps of thought for VHP, Wet and Dry Dry - wants no amount of condensation. The goal is to maintain concentration below the condensation point to prevent condensation on room surfaces. Wet - wants micro-condensation. The goal is to maintain concentration above the condensation point to induce condensation on room surfaces. Vapor Hydrogen Peroxide condensation causes corrosion. As VPHP condenses its concentration increases from 35% to 78%.2 This increase in concentration causes corrosion and surface damage such as bubbling of paint, flooring and walls.
A preliminary study at an intentionally higher hydrogen

CD & VPHP & States of Matter

Gas
98oF (37oC) Body Temp
Optimal State for Sterilization

228oF (109oC) Boiling Point 120oF (70oC)

98oF (37oC)Body Temp

70oF (21oC) Room Temp 52oF (11oC) Boiling Point

70F (21oC)Room Temp

Liquid

www.Chem4kids.com

Liquid

0oF (-17oC)

0oF (-17oC) -27oF (-33oC) Freezing/Melting Point

peroxide injection rate resulted in hydrogen peroxide condensation and room surface damage,
which demonstrated the adverse affects if the process was not adequately controlled. Following optimization according to the VHP 1000 cycle development guide, no further condensation or material incompatibilities were observed. 1
Surface damage due to hydrogen peroxide condensation.1 1. Anders Malmborg, Maria Wingren, Philippe Bonfield and Gerald McDonnell (Steris), VHP takes its Place in Room Decontamination, Clean Rooms Volume: 15 Issue: 11 November 2001 . 36 2. Carl Hultman, Aaron Hill and Gerald McDonnell, The Physical Chemistry of Decontamination with Gaseous Hydrogen Peroxide, Pharmaceutical Engineering, Vol. 27, No. 1, Jan/Feb 2007.

-40oF (-40oC)

Solid

-74oF (-59oC) Freezing/Melting Point

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Solid

Stop applying energy (+E) and VPHP returns to liquid HP

ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

CD vs. VPHP Cycle Times

Decontamination Images
Thermal Image of a Vapor Phase Hydrogen Peroxide Cycle (Poor Distribution)

Isolator Decontamination Dry Process Wet Process Chlorine Dioxide Room Decontamination Dry Process Dry Process Dry Process Wet Process Chlorine Dioxide

Volume 25 ft3 (0.7m3) 25 ft3 (0.7m3) 31 ft3 (0.88m3) Volume 300 ft3 (8.5m3) 530 ft3 (15m3) 760 ft3 (21.5m3) 2500 ft3 (70.8m3) 2700 ft3 (76.5m3)

Cycle Time 3-6 hours 1 3-3.5 hours 1.3 hours 2

Picture of a Chlorine Dioxide Gas Cycle (Excellent Distribution & Penetration

Cycle Time 7.5 hours 3 10+ hours7 4.25 hours +overnight aeration4 10-11 hours 5 3.5 hours 6

Warmer (more VPHP) Cooler (Less VPHP) Chlorine Dioxide Gas Even Distribution & Penetration 37

1. Caputo Ross A. and Jim Fisher. Comparing and Contrasting Barrier Isolator Decontamination Systems. Pharmaceutical Technology, Vol 28, No 11, p 68-82, November 2004. 2. Czarneski Mark A. and Paul Lorcheim. Isolator Decontamination Using Chlorine Dioxide Gas. Pharmaceutical Technology, Vol 29, No 4, p124133, April 2005. 3. Steris Case Study M1456, VHP Case Study #1 Hydrogen Peroxide Gas Decontamination of A Material Pass-Through (MPT) Room, Publication ID #M1456(8/99), Steris, August, 1999. 4. Steris Case Study M1455, Case Study #3 - VHP 1000 Decontamination of a 760 ft3 room Containing Blood and Urine Analyzers, Publication ID#M1455/990810 (8/99), Steris August 1999. 5. Room Decontamination Presentation to Council on Private Sector Initiatives, Washington, DC, by Henry Vance PE of Alpha Engineering, February 11, 2002. 6. Lorcheim Paul. Decontamination using Gaseous Chlorine Dioxide, A case study of automatic decontamination of an animal room explores the effectiveness of this sterilization system. Animal Lab News, Vol 3 No. 4, p25-28, July/August 2004. 7. Rogers James V., Choi Young W., and Richter, William R., Effects of Drying and Exposure to Vaporous Hydrogen Peroxide on the Inactivation of Highly Pathogenic Avian Influenza (H5N1) on non-porous Surfaces, Applied Biosafety Vol. 16 No. 1, pp4-8, 2011.

Aeration Comparison
530 ft3 (15m3)
1mg/L and 200 CFM exhaust rate Aeration time = 32 min Why Important Time Safety
90 80 70 60 50 40 30 20 10 0
69 73 77 81
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Cycle Development Questions

CD Gas Are Cycle Development Studies and Room Specific Evaluation Runs Required?
CD will aerate to the 8 hr TWA much faster than VPHP

VPHP Yes

No

Does the chamber size affect cycle development? Does the load pattern affect cycle development? Do shadow areas affect cycle development? Do multiple rooms affect cycle development? Do odd shaped rooms affect cycle development Does temperature affect cycle development

No No No No No No No

Yes Yes Yes Yes Yes Yes

Dry -40 Yes Wet No

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Does the Starting RH affect cycle development?

Cycle Parameter Development

CD Gas
Number of Generators Required initial injection rate? initial injection time? exposure injection rate? Exposure time Aeration Time 1982 cu m (70,000 cu ft) NA NA NA 120 min No Studies Required Automatically Monitored

Example Projects - Large

Example 1 CD Gas Decontamination New Animal Facility 180,000 ft3 (5097 m3), 65 room Decontaminated in 1 zone Equipment used 5 CD gas generators (1 generator for 36000 ft3 [1019 m3]) 70 Fans Example 2 VPHP Fumigation of Biomedical Research Building 23,000 ft3 (651 m3), 2 floors Divided into 4 zones and decontaminated separately Equipment used 17 Clarus R generators (1 generator for 1352 ft3 [38 m3]) 29 Clarus R2 aeration modules
Bio-decontamination of a Mouse Parvovirus Infected 23,000 ft3 biomedical research building http://www.bioquell.com/US/default.asp?id=359

VPHP
283 cu m (10,000 cu ft) Dependant on room configuration Evaluation runs required Evaluation runs required Evaluation runs required Evaluation runs required Evaluation runs required

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Example Projects Small Size

Example 1 CD Gas Large Animal Room (6300 ft3 178.4m3) Cycle time 4.4 hours Decontaminated empty or with equipment in same cycle time Equipment used 1 CD gas generator, 2 Humidifier & 3 Fan Example 2 Fumigation of Singapore hospital using HPV 2800 ft3 (79.3 m3), 11 room Equipment used 4 Clarus R generators (1 generator for 700 ft3 [19.8 m3]) 10 oscillating fans 12 Clarus R2 aeration modules
Fumigation of East Shore Hospital ICU, Singapore using Hydrogen Peroxide Vapor, http://www.bioquell.com/US/default.asp?id=351

4 Generators in Unknown Room Size

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Presentation at Canadian Biosafety Symposium Saskatoon, Saskatchewan, Uses and Applications of Hydrogen 44 Peroxide Vapor (HPV) Decontamination, Slide 8,Tom Gieseke Western Regional Manager Bioquell, June 1 - 3, 2008

Vapor Phase Hydrogen Peroxide (VPHP)

Pros Person removed from the process (Safety) No Residues (no post exposure cleanup required) US-EPA registered process Inexpensive consumables Cons High Cost Capital Equipment Not a true gas (boiling point +109oC) Vapor wants to return to normal state of a liquid as condensation Difficult cycle development High RH - exceeds 85% during process Not NSF approved for BSC cabinets Long Aeration Times (due to condensation and absorption) Some plastics absorb HP Trouble penetrating some HEPA filters Does not penetrate water Oxidizer Carcinogen (ACGIH Yes Class A3 animal / OSHA NO)

Chlorine Dioxide Gas

Easy process: place generator outside the room Dry gas generation process: Cl2(g) + 2NaClO2(s) = 2ClO2(g) + 2NaCl(s) 1 Gas Generator for approximately 70,000 cu ft. True Gas (boiling point +11oC) Requires RH 65+% Short cycle times (rooms 3-4 hours) Short contact times (0.5-2 hours) Non Flammable Low concentrations (360-1800 ppm)
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Chlorine Dioxide Gas

Pros Person removed from the process (Safety) No Residues (no post exposure cleanup required) US-EPA registered process NSF approved for BSC cabinets Inexpensive consumables True Gas (boiling point +11oC) Penetrates water Penetrates HEPA filters Photometric sterilant concentration monitoring and control Carcinogen (ACGIH NO, OHSA NO) Cons High Cost Capital Equipment Oxidizer
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Any Questions?????

BREAK

ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Oxidation Potential of Several Biocidal Agents

Biocidal Agent
More Corrosive

Myth of Corrosion

Oxidation Potential (volts) O3 (ozone) 2.07 CH3COOOH (peracetic acid) 1.81 H2O2 (peroxide) 1.78 NaOCl (sodium hypochlorite) 1.49 ClO2 (chlorine dioxide) 0.95

Oxidation Capacity (electrons) 2e 2e 2e 2e 5e

The above table summarizes key properties of oxidizing biocides. As shown, CD is not as aggressive an oxidizer (oxidation potential data) as chlorine, ozone, peracetic acid, hydrogen peroxide, or bleach and it is non corrosive to common materials of construction. The fact is that Vapor HP is 1.9 times more corrosive.
1. Barry Wintner, Anthony Contino, Gary ONeill, Chlorine Dioxide, Part 1 A Versatile, High-Value Sterilant for the Biopharmaceutical Industry, BioProcess International DECEMBER 2005

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Gaseous CD is not the same as Liquid CD

Liquid CD creates the chlorine dioxide through acidification of sodium chlorite
Common Liquid Generation Methods: Mixture of Base + Water + Activator = Acidified Sodium Chlorite + Chlorous Acid + Chlorine Dioxide

Decontamination Method Summary

Issue Equipment Cost Labor Costs Consumable Costs Facility Downtime Costs (cycle time costs) Corrosiveness Spray / Wipe /Mop / Fogging Ozone Formaldehyde Gas Hydrogen Peroxide Vapor Chlorine Dioxide Gas

Low High

Low

Low High

Low

Low Low

5 hrs (large) Not Measurable

Overall Effectiveness

Low

Low

High

Moderate

High

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CD is the Safest Fumigant

CD VPHP / IHP Formaldehyde Ozone

CD is the Safest Fumigant

EPA 738-R-06-007 Re-registration Eligibility Decision (RED) for Chlorine Dioxide and Sodium Chlorite (Case 4023) EPA 738-F-93-026 Re-registration Eligibility Decision (RED) for Peroxy Compounds (Case 4072)

At 8 hour safety level

nim 06-03

Aeration Time CD is the fastest to the TWA 8hr threshold

30-60 min

overnight

1 hour + cleanup

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Equipment Location

Outside room

/ Bioquell Inside Steris Outside room

Inside Room

Inside and Outside Room

Penetrate Water

YES (gas)

NO (Vapor)

YES (gas)

Yes

Penetration & Distribution

YES (gas)

NO (Vapor)

YES (gas)

Yes (gas)

Vented to Environment

YES

YES

NO

Yes

Carcinogen

NO - ACGIH NO - OSHA

YES ACGIH NO OSHA

YES

No

Cycle Times (Risk of Exposure)

3-4 hours

6-12 hours

12+ hours

6-72 hours

Odor Detection

YES

NO

YES

NO

Typical Concentrations

360 ppm

750 ppm

UE mpp5.0

(time weighted average)

8000 ppm

20-1000ppm

OSHA 8 hr TWA

0.1 ppm

1.0 ppm

0.75 ppm

0.1ppm

Toxicity Category I Toxicity Category II Toxicity Category III Toxicity Category IV

Categories from US-EPA

DANGER WARNING CAUTION None Required

http://www.epa.gov/oppfead1/labeling/lrm/chap-07.htm

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Comparison of liquid vs. gas showed a 3.7 log reduction with liquid CD and a 7.4 log reduction with gaseous CD with equal concentrations and 51 exposure times

Scalability

Yes

??

No

Yes

Yes??

Yes

EPA approvals

Yes (agent specific)

No

No

Yes (Steris only)

Yes

Only pure gas is delivered to the chamber, the salt solid remains in the CD Cartridge

Concentration Monitoring

No

Yes

No

Yes (not integrated to equipment)

Yes

Cl2(g) + 2NaClO2(s)

yields

2ClO2(g) + 2NaCl(s)

Residues

High

Not Measurable

High

Not Measurable

Gaseous CD is created through a dry gas process

Total Cycle Time

1-2 days

1-2 days

9 to 15 hours + clean up

4 hours (small) 12 hours (large)

1.5 hrs (small)

Low-High (agent specific)

High

Low

Liquid CD is corrosive due to acids involved in the generation process

Low (condensation )

Moderate

Moderate

Low

High

Low

High

Low

Low

Low

Low

Low

High

Moderate

ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

The Chlorine Dioxide Decontamination Process

Pre-Conditioning Chamber Leak Test and Raise RH 65%-75% Conditioning

What is the Process?

Dwell time at RH SP Charge Raise CD Concentration 1 - 5 mg/L Exposure Dwell time at CD SP Aeration Remove CD Gas 12-15 air exchanges
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The Chlorine Dioxide Decontamination Process

Pre-Condition Charge Condition Exposure Aeration

Chlorine Dioxide Generation Technology

90 80 70
Relative Humidity (%)

6 5
Concentration (mg/L)

Cl2(g) + 2NaClO2(s)

2ClO2(g) + 2NaCl(s)

4 3 2 1 0
9 13 1 5 25 29 17 21 33 45 49 37 41 53 57 61 73 77 65 69 81 85

60 50 40 30 20 10 0

Performed in solid phase Gas generated on demand Self-Contained reagents Simple to replace consumables Only pure gas is delivered to the chamber, the salt solid remains in the CD Cartridge

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Chlorine Dioxide D-Value Studies (Bacillus atropheus)

Carrier Kimguard (plastic) Paper 991
Condition time 70% for 30 minutes

Sample CD Antimicrobial Spectrum of Activity

Vegetative Bacteria:
Staphylococcus aureus Pseudomonas aeruginosa Salmonella cholerasuis Mycobacterium smegmatis E.Coli Listeria Monocytogenes

concentration mg/L 5 5 10 20 30

D-Value minutes 1.7 1.6 0.75 0.27 0.12

Bacterial Spores:
Bacillus atropheus * Bacillus stearothermophilus Bacillus pumilus Clostridium sporogenes

Paper Paper Paper

Condition 75% for 30 minutes

Tyvek/mylar envelopes

D-Value is the time to achieve a 1 log Reduction of microorganisms. 1 Log = 90% Reduction 2 Log = 99% Reduction 3 Log = 99.9% Reduction 4 Log = 99.99% Reduction 5 Log = 99.999% Reduction 6 Log = 99.9999% Reduction 59

Fungi:
Aspergillus niger Candida albicans Trychophyton mentagrophytes

Viruses:
Herpes simplex Type I (lipid) Polio Type II (non-lipid) Parvo Virus

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* CD Indicator Organism

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

MRSA and VRE Data

Standard Sporicidal Cycle Rooms RH - 65% with 10 minutes of condition time CD gas concentration of 1.0 mg/L Exposure - 120 minutes Overall exposure - 720 ppm-hrs demonstrates a 6 log reduction Staphylococcus aureus (MRSA) and Enterococcus faecium (VRE) RH - 65% with 30 minutes of condition time CD gas concentration of 0.2 mg/L Exposure - 45 minutes Overall exposure - 54 ppm-hrs demonstrates a 5 log reduction

Salmonella Data
Standard Sporicidal Cycle Rooms RH - 65% with 10 minutes of condition time CD gas concentration of 1.0 mg/L Exposure - 120 minutes Overall exposure - 720 ppm-hrs demonstrates a 6 log reduction Salmonella typhimurium (ATCC 14028) RH - 65% with 30 minutes of condition time CD gas concentration of 0.3 mg/L 100 ppm-hrs had a 6.999 log reduction 200 ppm-hrs had a 7.01 log reduction
61 62

Cloridox-GMP Portable CD Generator

1-1982 m3 (70,000 ft3 )Capacity Real-time Concentration Monitor Easy to Validate Easily Portable Capable of Connecting to and Controlling Autoclaves for Vacuum cycles

What Products / Services are Available?

Ideal application: GMP facilities or facilities where vacuum cycles need to be conducted in addition to the decontamination of rooms, isolators, equipment, or supplies.
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Minidox-M Portable CD Generator

1-1982 m3 (70,000 ft3 )Capacity Real-time Concentration Monitor Easy to Validate Easily Portable

Megadox

1- 7900 m3 (280,000 ft3) Capacity Real-time Concentration Monitor Easy to Validate Fixed in Place

Ideal application:

Ideal application:
Any facility looking to decontaminate rooms, isolators, equipment, or supplies.

Any facility looking to decontaminate large rooms, large equipment, or supplies.

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Gasketed Doors
Uses Rugged Non-Inflatable Gasket Turn Any Room into a Decontamination Room Use With Any Decontamination Technology Window For Viewing and Safety Ramp Included Optional Interlock When Used In A Passthrough Room Ideal application: Facilities looking to decontaminate components, parts, supplies or equipment entering a clean facility or exiting a BSL facility.

Decontamination Chamber
Can Replace Bulk Autoclave for Certain Applications Can Replace spray and wipe for all applications Able to Decontaminate Electronics Less Environmental Impact than Autoclaves Lower Maintenance Costs than Autoclaves Easy to Validate Single Door or Passthrough Chambers Ideal application: Decontaminating incoming products, equipment, or supplies into a research or production area.

Cost Saving CD vs Bulk Autoclave

Equipment Savings: Footprint Savings: Total Initial Savings: Yearly Savings Steam Savings: Water Savings: Electricity Savings: Gasket Savings: Potential Cage Savings: Consumable Costs: Total Yearly Savings: Potential Lifetime Savings (25-yrs): $29,400 to $144,900/yr $118,794/yr $828/yr $2500 to 4800/yr $70,000 to $140,000/yr ($19,695/yr) $201,827 to $389,627/yr
69 $5,181,675 to $10,746,675

Decon chamber vs. Autoclave

CD can do many things an autoclave can Equipment Bedding Bags Feed Bags CD can not do some things an autoclave can do Bedding Feed Liquids

Initial Cost Savings $85,000 to $220,000 $51,000 to $114,000 $136,000 to $334,000

What is right for your facility needs?? A Decon chamber ?? A Bulk autoclave ?? A combination of ??

Portable Decontamination Chamber

Can decontaminate small items for transport through a facility Able to Decontaminate Electronics More complete decontamination than spraying and wiping Easy to Validate Ideal application: Decontaminating products, equipment, or supplies into a research or production area.

Steridox-VP Vacuum Sterilizer

Standard and Custom Sizing Real-time Concentration Monitor Easy to Validate Able to Sterilize Electronics Less Environmental Impact than Autoclaves Lower Maintenance Costs than Autoclaves

Ideal application: Decontaminating incoming products, equipment, or supplies into a research or production area.

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Connection to Rooms through Under the Door Plate

1. CD Generator 2. Optional Under Door Plate

Connection to Rooms through Optional Door Plate

1. CD Generator
Thanks Steve Crowley

2. Optional Door Plate

73 74

Connection to Rooms through Optional Wall Plate

BSL-3 Overview Installation Diagram

Distance from Generator 500 ft (152m)

Minidox-M CD Gas Generator RH Probe

Fan RH Control Box RH Generator

75 76

Distribution Plate Installation

Distribution Plate Installation

Minidox-M CD Gas Generator Distribution Plate Outside Decon Area Ceiling Plate Inside Decon Room
77

Distribution Plate Outside BSL-3 Area Gas Generator Connections

Distribution Plate From Above Tubing and wiring connections to room. Installed during construction
78

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Ceiling Plate Installation

RH Probe Pressure Relief Valve Gas Sample Gas Inject

Mix Box for HEPA Housing

Tubing and wiring is run from distribution plate to the ceiling plate

Dimensions: 16x11x16 Weight: Approx. 8lbs

Ceiling Plate Inside BSL-3 Area
79 80

No Exhaust!!! Use the Scrubber System

If room exhaust does not exist or are not accessible to close. 2. Energize 1. Place carbon blower for scrubber in room aeration

No Exhaust!!! Use the Valve System

If room dampers do not exist or are not accessible to close then a valve sealing system is required. The system uses a motorized valve assembly attached to the exhaust or supply grill. At the end of exposure the valve is energized to utilize the house exhaust / supply.

Small chamber / BSC Scrubber

81

82

No Exhaust!!! Use the Bladder System

If room dampers do not exist or are not accessible to close then a bladder sealing system is required. The system uses a pipe plug assembly mounted to the exhaust or supply grill, then inflated with the pump system. At the end of exposure the pump tubing is reversed and the pipe plugs are deflated.

Decon Services
We can come on site and perform decontamination services for: Non-routine events where customer need is not often enough to justify equipment purchase Routine events when equipment is too costly Large volumes/ areas where many generator may be required Difficult applications where CSI knowledge is necessary CSI has years of decon service experience performing decontamination and sterilization around the world in the pharmaceutical, food and life science industries

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84

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Where To Perform Decon Service

Aseptic Rooms Processing Rooms Cold Rooms Holding Rooms Pass throughs BSL-1/2/3/4 (Level 3&4 most important) BSCs (A1/A2, B1/B2, Class III) HEPA Housings Duct Work Buildings / facilities Bulk Silos Dryers Processing tanks/ vessels Processing piping Any enclosed space needing decontamination

When to Perform Decon Service

Renovation Contamination Preventative Maintenance Between Batches During Shutdown Startup ..

85

86

Preventative Decon, How Often?

Yearly - Definitely Quarterly Possibly ?? Monthly Maybe ?? Weekly if critical ?? During Shutdown Always ..

How to do Decontamination Service

87

Complete Turnkey Decon Service

Performed for food, pharmaceutical, manufacturing, life science, or research industries 1. Ship Equipment and consumables to your facility 2. Arrive on site 3. Uncrate equipment 4. Set up equipment 5. DECON 6. Breakdown equipment 7. Crate equipment and leave 8. Provide report
89

Decon Site Preparation (Place Equipment)

Duration: 1 Day Steps: 1. Run gas inject tubing 2. Run sample tubing 3. Place distribution fans / blower 4. Seal HVAC (Supply and Exhaust) 5. Seal entry/exit doors 6. Place biological indicators (If required) 7. Seal LAST doorway 8. Start RH / Gassing

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Gassing Preparation Run Tubing

Gassing Preparation Seal Doorways

Gassing Preparation Seal Main Supply

Surface to Seal to eliminate leakage Area may be filled with gas and pull cord eliminates the need to enter area. Pull cord to remove tape.

Gassing Preparation Seal Roof Exhaust

Surface to Seal

Access Door

Gassing Preparation Place BIs

BI Placed in back corner

Decontamination Gassing Complete

Clean Up

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Gassing Complete Unseal Doorways

Gassing Complete Remove BIs

Gassing Complete Remove Tubing and Fans

Gassing Complete Remove Generators

Purge Regulators

Disconnect and Remove Generators

Equipment / Service Choices

Small Volume (0-300 cu ft) Cloridox-GMP Minidox-M Minidox-B Minidox-L CSI Decon Service Small Medium Volume (0-20,000 cu ft) Cloridox-GMP Minidox-M Minidox-B CSI Decon Service
101

Chlorine Dioxide Summary

Biocidal at Low Concentration and Ambient Temperature Efficacious under vacuum or at atmospheric pressure Gas Distributes Rapidly Gas Penetrates crevices Process Tolerates Temperature Fluctuations Non-flammable at Use Concentrations No Liquids Self-contained Reagents Short Cycles Size Scalable Range of Target Volumes Long Distances No Measurable Residuals Rapid Aeration (Low-Use Concentration and Minimal Adsorption) Gas Concentration is Easily and Accurately Monitored No manual wiping required No neutralization required No mixing of solutions
102

Large Volume (0-70,000 cu ft) Megadox CSI Decon Service Whole Facility CSI Decon Service

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Example Application:

Questions??

Lunch
103 104

65 Room (180,000 ft3 5097 m3) New Animal Facility Initial Decontamination Service

65 Room New Animal Facility Chemistry Labs

10 Injection Locations 20 Sensor Locations

6 7 3 4 4 2

10 20 6 18

1 9 16

8 5 9 3 12 1

15 10 2

14 7

19

17

13

11

105

106

65 Room New Animal Facility Changing Stations and BSCs

65 Room New Animal Facility Storage Rooms

107

108

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

65 Room New Animal Facility Animal Holding Rooms

Decontamination of Protein Powder Grinding, Drying, and Packaging Facility (6796 cu m - 240,000 cu ft)

109 110

Decontamination of Grain Refining and Packaging Facility (6512cu m - 230,000 cu ft)

Sterilization of Juice Storage Tank with Piping

111

112

Sterilization of Intermodal transportation containers

Decontamination of New Facility (Japan)

Quarantine room Rat suite Mouse suite Mouse suite Embryo manipulation room

3F
Staff room Rat suite Cage stock room Mouse suite Mouse suite
113

3F

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Decontamination of New Facility (Singapore)

Sensor tubing Gas Inject tubing

4th

Decontamination of New Facility Georgia State University 2265 sq m (6796 cu m - 240,000 cu ft)

3rd

2nd Generator
and EMS sensor location 3rd floor

1st Tubing Run from 3rd floor loading dock to 1st floor 207 ft (63m)
116

Component Load Transfer Isolator (25 ft3) Total 31 ft3 (0.9m3) with docking station
Total Decontamination Cycle Time - 1 hour 20 minutes Example of Good Penetration Ability
There were a total of 25 biological indicators (Bacillus subtilis) placed throughout the chamber and load with NO positives.
117

Train of Isolators (279 ft3 - 7.9m3)

CD Gas Injection

Workstation Isolator

Autoclave Interface Autoclave Isolator

Example of Good Distribution Ability

There were a total of 24 biological indicators (Bacillus subtilis) placed throughout the chamber and load with NO positives.

Workstation Isolator / Autoclave Interface Isolator and Autoclave (Total Decontamination Cycle Time - 1 hour 52 minutes)

Microbial Challenge Room (6000 ft3 - 170m3)

Decontamination Chamber (220 ft3 - 6m3)

Example of Good Material Compatibility

Cardinal Health Woodstock, IL 119 120

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

BI Location Inside Stack of Lids

Chlorine Dioxide Gas has excellent penetration abilities

For example..

No Growth After Incubation

Example of EXCELLENT Penetration Ability
122

BI Location Inside Open and Closed Cabinets

Example of EXCELLENT Penetration Ability

BI Location Under Equipment

Example of EXCELLENT Penetration Ability

BI Placed in OPEN Cabinet

BI Placed in CLOSED Cabinet

123

BI Placed UNDER Equipment

Both BIs Killed

Both BIs Killed

124

BI with Organic Load (vacuum cleaner dust)

Example of EXCELLENT Penetration Ability in dirty load

BI Location In Ventilated Rack

Biological Indicators Placed In: -HEPA Housing -Supply Air Plenum -Return Air Plenum -Large Cage -Large Cage Water Bottle -Small Cage -Small Cage Water Bottle -Animal Feed Water Tubing

All 6 BIs Killed

125 Photos

No Growth After Incubation

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

HEPA Housing (University of Louisville)

Sterilizing Filters (mounted incorrectly)

127

128

Equipment Decontamination

Transport Vehicles (Hilltop Lab Animals)

129

130

Necropsy Rooms

Surgical Suite (2000 ft3 - 56.6m3)

Example of Good Material Compatibility

131 132

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Passthrough Rooms

Pass Through Room (864 ft3 - 24.5m3)

Example of Good Penetration Ability

133

134

Passthrough Rooms (VHP replacement)

Lumen Sterilizer Load (Total Sterilization Cycle Time - 3 hour 40 minutes)

Example of Good Penetration Ability

135 136

Aseptic Juice Filling Room 115 sq m (20,000 ft3 566.3 m3)

Pharmaceutical Aseptic Filling Suite 15,000 ft3 (424m3)

137

Location: Major Pharmaceutical Manufacturer in Korea 138

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Pharmaceutical Chemistry Lab 160 sq m (17,000 ft3 - 481 m3)

Process Tanks and Piping

Example of Long Distances True Gases Can Travel

139

140

Building (167,000 ft3 - 4730m3)

Chlorine Dioxide Gas has good material compatibility

For example..

University of Pennsylvania Bolton Center Kennett Square, PA 141

Various Equipment

Automated Guided Vehicle (AGV)

143

144

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Various Equipment

Various Equipment

145

146

Various Equipment

Various Equipment

147

148

Workstation Isolator (350 ft3 - 10m3)

Filling Line Isolator (250 ft3 - 7m3)

149

Amgen Thousand Oaks, CA

150

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Flexible Isolators (25-30 ft3 - 0.7-0.8m3)

Rigid Isolator (100 ft3 - 2.8m3)

151

152

Summary Example Application Data

Safest fumigant available (odor detection, low concentration levels, non-carcinogen) Fastest cycle times (start to finish) Most complete Penetration and Distribution Most Flexible Process (rooms, BSCs, HEPA Housing, Duct work, isolators, suite of rooms, etc) Sterilant process EPA Approved process NSF Approved process
153 154

The following slides give examples of chlorine dioxide exposure on different produce. Data is compiled from several paper published by Purdue University (Dr. Y. Han, Dr. R. Linton and Dr. P. Nelson.

All the treatments were for 10 min at 20oC.

Aqueous and Gaseous ClO2 vs. Washing for Reducing L. monocytogenes on Peppers
9 8
Aa

Uninjured Surface Injured Surface

Bx Ab

Log Reductions

7 6 5 4 3 2 1 0
By

Ac By

(Han, Y. et al, Reduction of Listeria monocytogenes on Green Peppers (Capsicum annuum L.) by Gaseous 155 and Aqueoous Chlorine Dioxide and Water Washing and Its Growth at 7oC, Journal of Food Protection, Vol 64, No 11, 2001 pages 1730-1738)

3 mg/l ClO2 Gas 3 mg/l ClO2 Treatment at 90% RH Solution Treatment

Water Washing

Untreated and stored for 6 weeks at 4oC

Treated with 10 mg/l Chlorine dioxide gas for 10 min and stored for 6 weeks at 4oC

Han Y., Linton, R.H., and Nelson, P.E., Inactivation of Escherichia coli O157: H7 and Listeria 156 monocytogenes on strawberry by chlorine dioxide gas, annual meeting of Institute of Food Technologists, Anaheim, CA, 2002.

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

Day 9 at room temperature

Prepared by: Mark A. Czarneski Director of Technology ClorDiSys Solutions, Inc www.clordisys.com PO Box 549 Lebanon, NJ 08833 Phone: 908-236-4100 Fax: 908-236-2222 e-mail: markczarneski@cloridsys.com or e-mail: paullorcheim@clordisys.com

Control

5 mg l-1/2min

5 mg l-1/10min
157 158

Purdue Study (Materials of Construction)

Chlorine Dioxide Chamber 304 stainless ~75 ft3 Fruits and Vegetables Materials Compatibility Aseptic Materials HVAC materials Electronics Emulate Aseptic Bio-Decon 2mg / Liter 6 hours Extended testing Materials left at Purdue
159

Materials Compatibility Study

160

Conclusions of Purdue Materials Study

Metals No oxidation observed 316L, 304, Copper, anodized Al, Novel metals Polymers No oxidation observed PVC, Lexan, Epoxy, PP, Phenolic, Urethane binders Siloxane gels absorbed/desorbed Electronics No oxidation observed Contacts intact Incompatible with Cast aluminum Urethane foam Clear flexible urethanes Materials, materials, materials

HEPA Filter Manufacturing and Use

Not manufactured in GMP facility Warehouse environment Some aspects conducted outside Limited data suggests new HEPA filters will grow HEPA filters cannot be heat sterilized Filter media damaged by mechanical cleaning Not sterile when installed

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ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

HEPA Filter Study at Purdue University

Remediation Study 10 mg/L, 95% RH, 2 hours 5 mg/L 95% RH, 2 hours BI Geobacillus stearothermophilus. BIs inserted 6 inches into pleat No air circulated through filter Analysis BIs neutralized w/ Sodium Thiosulfate Incubated in TSB at 58 for 7days C Results No BI growth Data shared with HEPA Mfgs Interest in supplying sterilized filters
163

Crevice Contaminations

Courtesy of Jenny Scott Office of Food Safety, Center for Food Safety and Applied Nutrition, U.S. Food & Drug Administration. The
Significance of Persistent Bacterial Strains in the Food Processing Environment, IAFP 2011 Milwaukee

Colonization by Pseudomonas fluorescens CCL 134 of a hole in a PVC conveyor belt (four day culture in meat exudate)
(Midelet, G., Carpentier, B., 2002. Transfer of microorganisms, including Listeria monocytogenes, from various materials to beef. Applied and Environmental Microbiology 68, 40154024.

164

PPM-Hrs Explanation
Standard CD Cycle is
RH - 65% with 10 minutes of condition time CD Concentration - 1mg/L CD Exposure time 2 hrs

PPM calculation for 1mg/L

PPM = (mg/M3) (24.45) / Molecular Weight PPM = (mg/L) (1000) (24.45) / Molecular Weight CD ppm = (1.0mg/L) (1000L/M3) (24.45) / 67.5 CD ppm = 362.2

Exposure Contact Time (CT) Exposure CT = 362ppm * 2 hrs Exposure CT = 724 ppm-hrs
The number 24.45 in the equations above is the volume (liters) of a mole (gram molecular weight) of a gas at 1 atmosphere and at 25 C.

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