clordisys decontamination presentation

ClorDiSys Solutions, Inc. Chlorine Dioxide Workshop Presentation

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Revision Date: June 22, 2008

Worlds Largest Supplier of Gaseous Chlorine Dioxide

Decontamination Equipment and Services

Mark A. CzarneskiDirector of Technology

NEWS: CD is now NSF approved for BSC Decontamination

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Overview

1. When, Where, Why ?

2. Define Chlorine Dioxide

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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What Industries Should be Interested in Chlorine Dioxide

� Food

� Pharmaceutical

� Healthcare

� Life Science

How does a facility get contaminated?

How does your product get contaminated?

Contamination can occur at any step in the process—during

production, processing, distribution, transportation, preparation, etc.

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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 nation’s peanut producers from the 2009 salmonella contamination of peanut butter [Associated Press; Last Accessed 3.17.10]: $1 Billion

3. Estimated cost to Florida’s 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 health-related expenses.

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-Costs-Report.pdf-1.pdf. Accessed on: 05/13/2010.

Why should there be interest in Food Facility Decontamination?

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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 FDA’s 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 FDA’s 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.htm6

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, 2002http://www.cdc.gov/ncidod/dhqp/pdf/hicpac/infections_deaths.pdf


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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 entericaserovar Newport MDR-AmpC in a large animal veterinary teaching hospital“, J Vet Intern Med. 2010 Sep-Oct;24(5):1138-46. doi: 10.1111/j.1939-1676.2010.0546.x. Epub 2010 Jun 24.

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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

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When To Use Chlorine Dioxide Gas

� Renovation

� Between Population / Production Batches

� Commission

� De-Commissioning

� Contamination

� Preventative Maintenance

� …..

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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

� BSC’s (A1/A2, B1/B2, Class III)

� HEPA Housings / Duct work

� Silo’s / Dryers

� Buildings / facilities

� Processing piping

� Processing tanks and vessels

� …..

� Any enclosed space needing decontamination

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Chlorine Dioxide, NSF and BSC’s

Chlorine Dioxide Gas has been approved by NSF International under Annex G of NSF/ANSI 49 for

the decontamination of BSC’s

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)

NO other method approved for BSC decontamination

NOTE: Vapor Phase Hydrogen Peroxide is NOT NSF approved12

Why Use Chlorine Dioxide Gas

Both gases (VHP and CD) are effective against biological agents and residual chemical agents, but destruction of some chemical agents is slow.

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 Chemical Attacks in the Civilian Sector” SCIENCE VOL 302 #21 NOVEMBER 2003 pp1350-1354.

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


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What is Chlorine Dioxide (CD) ?

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.

www.Chem4kids.com

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

-40oF (-40oC)

0oF (-17oC)

52oF (11oC) Boiling Point

70o F (21oC) Room Temp

Ch

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Chlorine Dioxide Time Line

Aqueous Germicide (Water Treatment

Longest User)

1811

First Preparation of Chlorine Dioxide

Bleaching Agent (Pulp & Paper Industry Largest User)

Chlorine Dioxide Recognized as a Gaseous

Chemosterilizing Agent

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

1920 1984

1988

Mar 2004

CSI CD-Cartridge Registered with US-EPA

� 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 lb’s / hour (1.4kg / hour)of CD to be emitted

1940

Time

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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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Current Sterilizer (Sporicides)Registration with

US-EPA as of January 2009

http://www.epa.gov/oppad001/chemregindex.htm

Agent Quantity

Ethylene Oxide 24

Sodium Chlorite (chlorine dioxide) 4

Hydrogen Peroxide Based 12

Total 40

More than 5000 antimicrobial products are

currently registered with the US-EPA.

Only 40 agents are registered as a Sterilant.

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Current Sodium Chlorite (Chlorine Dioxide) Sterilizer Registration

For Anthrax cleanup Under Section 18 of FIFRA, EPA exempted Sabre Technologies

from any provision of EPA registration requirement for sale or use.

http://www.epa.gov/oppad001/chemregindex.htm

Company Produce Name Registration #

Ingredient %

Sterilization Use

Alcide Corp Alcide Exspor 4:1:1 – Base

1677-216 1.520% Immerse in solution for 10 hours @ 20 deg C

ClorDiSys Solutions, Inc.

CSI CD Cartridge

80802-1 72.8% Follow System Operations Guide

Englehard Corp Aseptrol S10-Tab

70060-19 20.8% Immerse or soak in 1000 ppm solution for min 1 hour

Pharmacal Research Laboratories Inc

CLIDOX-S BASE

8714-8 0.85% 1:3:1 Dilution for 5 hours @ 25 deg C


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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

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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

� Pro’s

� Low cost

� Minimal Equipment (buckets, spray bottles, mops)

� Easy job

� Con’s

� Difficult job

� Hard to reach all surfaces

� Under side of components

� Behind equipment

� Ceilings

� Ventilation grills

� Intricate components

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� 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

Fogging

Various Foggers

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Fogging

� Pro’s� Person removed from the process

(Safety)� Low cost consumables� Low cost equipment� Minimal Equipment ($300 fogger +

consumables)� Con’s

� 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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Ionized HP Fogging

� Pro’s� Person removed from the process

(Safety)� Low cost consumables� Lower HP concentration (7.5%)

compared to VPHP [oxidation]

� Con’s� 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)26

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

Iodophor

� Pro’s

� Low cost

� No residues - when used in proper proportions it evaporates directly from solution to gas, and hence leaves no residues

� Con’s

� 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

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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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� Pro’s� Person removed from the process (Safety)� 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

� Con’s� 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: http://www.iarc.fr/ENG/Press_Releases/archives/pr153a.html

Formaldehyde Gas

Electric Frying Pan

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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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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

� Con’s� 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.pdf6 hours exposure 1000ppm 4.3log reduction of spores with high RH >80%

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Ethylene Oxide Gas (EtO)

� Automated process

� True Gas (boiling point +10.7oC)


� Injected into a SS chamber

� Process is run under vacuum

� High concentrations

� Used in most hospitals

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� Pro’s

� Low cost consumables

� Penetrates HEPA filters

� True gas at room temperatures (boiling point +10.7oC)

� Non corrosive

� Excellent penetration

� Con’s

� Carcinogen (IARC*)

� Explosive

� Required Damage Limiting Construction (DLC)

� Excellent penetration

� Long aeration times

Ethylene Oxide Gas (EtO)

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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)

� Low concentrations (700-1500ppm)

Hydrogen Peroxide (35%)

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CD & VPHP & States of Matter

-40oF (-40oC)

0oF (-17oC)

52oF (11oC) Boiling Point

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

0oF (-17oC)

70oF (21oC) Room Temp

98oF (37oC)Body Temp

www.Chem4kids.com

Optimal State for Sterilization

So

lid

98oF (37oC) Body Temp

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

228oF (109oC)Boiling Point

120oF (70oC)

Optimal State for Sterilization

70F (21oC)Room Temp

Chlorine Dioxide

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

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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 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 .

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.


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Decontamination Images

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

Chlorine Dioxide Gas Even Distribution & Penetration

Warmer (more VPHP)

Cooler (Less VPHP)

Picture of a Chlorine Dioxide Gas Cycle (Excellent

Distribution & Penetration

CD vs. VPHP Cycle TimesIsolator

Decontamination Volume Cycle TimeDry Process ≈≈≈≈ 25 ft3 (0.7m3) 3-6 hours 1

Wet Process ≈≈≈≈ 25 ft3 (0.7m3) 3-3.5 hours 1

Chlorine Dioxide 31 ft3 (0.88m3) 1.3 hours 2

Room Decontamination Volume Cycle TimeDry Process 300 ft3 (8.5m3) 7.5 hours 3

Dry Process 530 ft3 (15m3) 10+ hours7

Dry Process 760 ft3 (21.5m3) 4.25 hours +overnight aeration4

Wet Process 2500 ft3 (70.8m3) 10-11 hours 5

Chlorine Dioxide 2700 ft3 (76.5m3) 3.5 hours 6

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, p124-133, 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.

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Aeration Comparison530 ft3 (15m3)

65 69 73 77 81 85

0

10

20

30

40

50

60

70

80

90

•1mg/L and 200 CFM exhaust rate

• Aeration time = 32 min

•Why Important•Time •Safety

CD will aerate to the 8 hr TWA much faster than

VPHP

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Cycle Development Questions

CD Gas VPHP

Are Cycle Development Studies and Room

Specific Evaluation Runs Required?No Yes

Does the chamber size affect cycle

development?No Yes

Does the load pattern affect cycle development? No Yes

Do shadow areas affect cycle development? No Yes

Do multiple rooms affect cycle development? No Yes

Do odd shaped rooms affect cycle development No Yes

Does temperature affect cycle development No Yes

Does the Starting RH affect cycle development? NoDry - Yes

Wet – No

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Cycle Parameter Development

CD Gas VPHP

Number of Generators Required1982 cu m

(70,000 cu ft)

283 cu m (10,000 cu ft)

Dependant on room

configuration

initial injection rate? NA Evaluation runs required

initial injection time? NA Evaluation runs required

exposure injection rate? NA Evaluation runs required

Exposure time

120 min

No Studies

Required

Evaluation runs required

Aeration TimeAutomatically

MonitoredEvaluation runs required

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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

Example Projects - Large


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� 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 modulesFumigation of East Shore Hospital ICU, Singapore using Hydrogen Peroxide Vapor,

http://www.bioquell.com/US/default.asp?id=351

Example Projects – Small Size

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

4 Generators in Unknown Room Size

� Pro’s� Person removed from the process (Safety)� No Residues (no post exposure cleanup required)� US-EPA registered process� Inexpensive consumables

� Con’s� 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)

Vapor Phase Hydrogen Peroxide (VPHP)

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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)


� 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

� Pro’s� 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)

� Con’s � High Cost Capital Equipment� Oxidizer

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Any Questions?????

BREAK


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Myth of Corrosion

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Oxidation Potential of Several Biocidal Agents

Biocidal Agent Oxidation Potential Oxidation Capacity

(volts) (electrons) 1

O3 (ozone) 2.07 2e–

CH3COOOH (peracetic acid) 1.81 2e–

H2O2 (peroxide) 1.78 2e–

NaOCl (sodium hypochlorite) 1.49 2e–

ClO2 (chlorine dioxide) 0.95 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 O’Neill, 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 asLiquid 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

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

� Gaseous CD is created through a dry gas process

Cl2(g) + 2NaClO2(s) yields 2ClO2(g) + 2NaCl(s)

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

� 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 exposure times 52

Decontamination Method Summary

IssueSpray / Wipe

/Mop / Fogging OzoneFormaldehyde

GasHydrogen

Peroxide VaporChlorine

Dioxide Gas

Equipment Cost Low ☺☺☺☺ Low ☺☺☺☺ Low ☺☺☺☺ High ☹☹☹☹ Moderate ☺☺☺☺Labor Costs High ☹☹☹☹ Low ☺☺☺☺ High ☹☹☹☹ Low ☺☺☺☺ Low ☺☺☺☺Consumable Costs Low ☺☺☺☺ Low ☺☺☺☺ Low ☺☺☺☺ Low ☺☺☺☺ Low ☺☺☺☺Facility Downtime Costs (cycle time costs)

High ☹☹☹☹ Moderate ☹☹☹☹ High ☹☹☹☹ Moderate ☹☹☹☹ Low ☺☺☺☺Corrosiveness

Low-High ☺☺☺☺ ☹☹☹☹(agent specific)

High ☹☹☹☹ Low ☺☺☺☺ Low ☺☺☺☺(condensation ☹☹☹☹)

Low ☺☺☺☺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) ☺☺☺☺

5 hrs (large)

Residues High ☹☹☹☹ Not Measurable ☺☺☺☺ High ☹☹☹☹ Not Measurable ☺☺☺☺ Not Measurable ☺☺☺☺Concentration Monitoring

No ☹☹☹☹ Yes ☺☺☺☺ No ☹☹☹☹ Yes ☺☺☺☺ (not integrated to equipment) ☹☹☹☹ Yes ☺☺☺☺

EPA approvalsYes ☺☺☺☺

(agent specific)No ☹☹☹☹ No ☹☹☹☹ Yes

(Steris only) ☺☺☺☺ Yes ☺☺☺☺Scalability Yes ☺☺☺☺?? No ☹☹☹☹ Yes ☺☺☺☺ Yes?? ☺☺☺☺ ☹☹☹☹ Yes ☺☺☺☺Overall Effectiveness Low ☹☹☹☹ Low ☹☹☹☹ High ☺☺☺☺ Moderate ☺☺☺☺ ☹☹☹☹ High ☺☺☺☺

53

CD is the Safest Fumigant

CD VPHP / IHP Formaldehyde Ozone

OSHA 8 hr TWA (time weighted average)

0.1 ppm ☹☹☹☹ 1.0 ppm ☹☹☹☹0.5ppm EU0.5ppm EU0.5ppm EU0.5ppm EU 0.75 ppm ☹☹☹☹ 0.1ppm ☹☹☹☹Typical Concentrations 360 ppm ☺☺☺☺ 750 ppm ☹☹☹☹ 8000 ppm ☹☹☹☹ 20-1000ppm ☺☺☺☺Odor Detection YES ☺☺☺☺

At 8 hour safety levelNO ☹☹☹☹ YES ☺☺☺☺ NO ☹☹☹☹

Cycle Times(Risk of Exposure)

3-4 hours ☺☺☺☺ 6-12 hours ☹☹☹☹ 12+ hours ☹☹☹☹ 6-72 hours ☺☺☺☺Carcinogen

NO - ACGIH ☺☺☺☺NO - OSHA☺☺☺☺ YES – ACGIH ☹☹☹☹

NO – OSHA ☺☺☺☺ YES ☹☹☹☹ No ☺☺☺☺Vented to Environment YES ☺☺☺☺ YES ☺☺☺☺ NO ☹☹☹☹ Yes ☺☺☺☺Penetration & Distribution

YES (gas) ☺☺☺☺ NO (Vapor) ☹☹☹☹ YES (gas) ☺☺☺☺ Yes (gas) ☺☺☺☺Penetrate Water YES (gas) ☺☺☺☺ NO (Vapor) ☹☹☹☹ YES (gas) ☺☺☺☺ Yes ☺☺☺☺Equipment Location Outside room☺☺☺☺ Bioquell Inside ☹☹☹☹ /

Steris Outside room ☺☺☺☺ Inside Room ☹☹☹☹ Inside and Outside Room ☺☺☺☺

Aeration TimeCD is the fastest to the TWA 8hr threshold

30-60 min☺☺☺☺ overnight ☹☹☹☹ 1 hour + cleanup ☹☹☹☹ 30303030----60 min 60 min 60 min 60 min ☺☺☺☺ 54

CD is the Safest Fumigant

Toxicity Category I DANGER

Toxicity Category II WARNING

Toxicity Category III CAUTION

Toxicity Category IV None Required

Categories from US-EPA http://www.epa.gov/oppfead1/labeling/lrm/chap-07.htm

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)


10

55

What is the Process?

56

The Chlorine Dioxide Decontamination Process

� Pre-Conditioning

Chamber Leak Test and Raise RH 65%-75%

� Conditioning

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

57

The Chlorine Dioxide Decontamination Process

0

1

2

3

4

5

6

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

0

10

20

30

40

50

60

70

80

90Exposure AerationCondition

Co

ncen

trati

on

(m

g/L

)

Rela

tive H

um

idit

y (

%)

ChargePre-Condition

58

Chlorine Dioxide Generation Technology

Cl2(g) + 2NaClO2(s) 2ClO2(g) + 2NaCl(s)

� 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

59

Chlorine Dioxide D-Value Studies (Bacillus atropheus)

Tyvek/mylar envelopes

concentration D-ValueCarrier mg/L minutes

Kimguard (plastic) 5 1.7Paper 991 5 1.6Condition time 70% for 30 minutes

Paper 10 0.75Paper 20 0.27Paper 30 0.12Condition 75% for 30 minutes

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



6 Log = 99.9999% Reduction 60

Sample CD Antimicrobial Spectrum of Activity

Vegetative Bacteria:� Staphylococcus aureus

� Pseudomonas aeruginosa

� Salmonella cholerasuis

� Mycobacterium smegmatis

� E.Coli

� Listeria Monocytogenes

Fungi:� Aspergillus niger

� Candida albicans

� Trychophyton mentagrophytes

* CD Indicator Organism

Bacterial Spores:

� Bacillus atropheus *

� Bacillus stearothermophilus

� Bacillus pumilus

� Clostridium sporogenes

Viruses:

� Herpes simplex Type I (lipid)

� Polio Type II (non-lipid)

� Parvo Virus


11

61

MRSA and VRE Data

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

Standard Sporicidal Cycle Rooms






62

Salmonella Data

Salmonella typhimurium (ATCC 14028)



100 ppm-hrs had a 6.999 log reduction

200 ppm-hrs had a 7.01 log reduction

Standard Sporicidal Cycle Rooms






63

What Products / Services are Available?

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

Ideal application:

GMP facilities or facilities where vacuum cycles need to be conducted in addition to the decontamination of rooms, isolators, equipment, or supplies.

Minidox-M Portable CD Generator

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

Ideal application:

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

66

Megadox

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

Ideal application:

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


12

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.

69

Cost Saving CD vs Bulk Autoclave

Steam Savings: $29,400 to $144,900/yr

Water Savings: $118,794/yr

Electricity Savings: $828/yr

Gasket Savings: $2500 to 4800/yr

Potential Cage Savings: $70,000 to $140,000/yr

Consumable Costs: ($19,695/yr)

Equipment Savings: $85,000 to $220,000

Footprint Savings: $51,000 to $114,000

Potential Lifetime Savings (25-yrs): $5,181,675 to $10,746,675

Yearly Savings

Initial Cost Savings

Total Initial Savings: $136,000 to $334,000

Total Yearly Savings: $201,827 to $389,627/yr

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

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.


13

73

Connection to Rooms through Under the Door Plate

1. CD Generator

2. Optional Under Door Plate

Thanks Steve Crowley 74

Connection to Rooms through Optional Door Plate

1. CD Generator

2. Optional Door Plate

75

Connection to Rooms through Optional Wall Plate

Fan

RH Probe RH

Generator

RH Control Box

Minidox-M CD Gas Generator

76

BSL-3 Overview Installation Diagram

Distance from Generator 500 ft (152m)

77

Distribution Plate Installation

Distribution PlateOutside Decon Area

Minidox-M CD Gas Generator

Ceiling PlateInside Decon Room 78

Distribution Plate Installation

Distribution PlateOutside BSL-3 Area

Gas Generator Connections

Distribution Plate From Above

Tubing and wiring connections to room. Installed during construction


14

79

Ceiling Plate Installation

Ceiling Plate Inside BSL-3 Area

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

RH ProbePressure Relief Valve

Gas SampleGas Inject

80

Mix Box for HEPA Housing

Dimensions: 16”x11”x16”Weight: Approx. 8lbs

81

No Exhaust!!! Use the Scrubber System

If room exhaust does not exist or are not accessible to close.

1. Place carbon scrubber in room

2. Energize blower for aeration

Small chamber / BSC Scrubber

82

No Exhaust!!! Use the Valve SystemIf 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.

83

No Exhaust!!! Use the Bladder SystemIf 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.

84

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


15

85

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)

� BSC’s (A1/A2, B1/B2, Class III)

� HEPA Housings

� Duct Work

� Buildings / facilities

� Bulk Silo’s

� Dryers

� Processing tanks/ vessels

� Processing piping

� Any enclosed space needing decontamination86

When to Perform Decon Service

� Renovation

� Contamination

� Preventative Maintenance

� Between Batches

� During Shutdown

� Startup

� …..

87

Preventative Decon, How Often?

� Yearly - Definitely

� Quarterly – Possibly ??

� Monthly – Maybe ??

� Weekly – if critical ??

� During Shutdown – Always

� …..How to do Decontamination Service

89

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

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


16

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

Access Door

Surface to Seal

Gassing Preparation – Place BI’s

BI Placed in back corner

Decontamination Gassing Complete

Clean Up


17

Gassing Complete – Unseal Doorways Gassing Complete – Remove BI’s

Gassing Complete – Remove Tubing and Fans Gassing Complete – Remove Generators

Purge Regulators Disconnect and Remove Generators

101

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


Large Volume (0-70,000 cu ft)

� Megadox


Whole Facility


102

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


18

103

Questions??

Lunch

104

Example Application:

105

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

Injection Locations

Sensor Locations20

10

10

6

2 7

9

1

5

4

3

8

19 17

18 16

15

13 11

12

14

1

2

3

4

5

6

7

8

9

10

20

106

65 Room New Animal Facility Chemistry Labs

107

65 Room New Animal Facility Changing Stations and BSC’s

108

65 Room New Animal Facility Storage Rooms


19

109

65 Room New Animal Facility Animal Holding Rooms

110

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

111

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

112

Sterilization of Juice Storage Tank with Piping

113

Sterilization of Intermodal transportation containers

3F

3F

Mouse suite Embryo manipulation room

Staff room

Rat suite

Rat suite

Cage stock room

Mouse suite

Mouse suite

Mouse suite

Quarantine room

Decontamination of New Facility (Japan)


20

Decontamination of New Facility (Singapore)

4th

3rd

2nd

1st

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

Generator and EMS sensor location 3rd floor

Sensor tubing

Gas Inject tubing

116

Decontamination of New FacilityGeorgia State University

2265 sq m (6796 cu m - 240,000 cu ft)

117

Total Decontamination Cycle Time - 1 hour 20

minutes

Component Load Transfer Isolator (25 ft3)Total 31 ft3 (0.9m3) with docking station

Example of Good Penetration Ability

There were a total of 25 biological indicators (Bacillus subtilis) placed throughout the chamber and load with NO positives.

Workstation Isolator

Autoclave Interface Isolator

Autoclave

CD Gas Injection

Train of Isolators (279 ft3 - 7.9m3)

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)

119

Cardinal Health Woodstock, IL

Microbial Challenge Room (6000 ft3 - 170m3)

Example of Good Material

Compatibility

120

Decontamination Chamber(220 ft3 - 6m3)


21

Chlorine Dioxide Gas has excellent penetration abilities

For example……..

122

No Growth After Incubation

BI Location Inside Stack of Lids

Example of EXCELLENT Penetration Ability

123Both BI’s Killed

BI Location Inside Open and Closed Cabinets


BI Placed in OPEN Cabinet BI Placed in CLOSED Cabinet

124

BI Location Under Equipment


Both BI’s Killed

BI Placed UNDER Equipment

125

BI with Organic Load (vacuum cleaner dust)

Example of EXCELLENT Penetration Ability in

dirty load

All 6 BI’s Killed

126Photos

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

No Growth After Incubation

BI Location In Ventilated Rack


22

127

HEPA Housing (University of Louisville)

128

Sterilizing Filters (mounted incorrectly)

129

Equipment Decontamination

130

Transport Vehicles (Hilltop Lab Animals)

131

Necropsy Rooms

132

Surgical Suite (2000 ft3 - 56.6m3)

Example of Good Material

Compatibility


23

133

Passthrough Rooms

134

Pass Through Room(864 ft3 - 24.5m3)

Example of Good Penetration

Ability

135

Passthrough Rooms (VHP replacement)

136

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

Example of Good Penetration

Ability

137

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

138

Pharmaceutical Aseptic Filling

Suite 15,000 ft3 (424m3)

Location: Major Pharmaceutical Manufacturer in

Korea


24

139

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

140

Process Tanks and Piping

Example of Long Distances True

Gases Can Travel

141

University of Pennsylvania Bolton Center

Kennett Square, PA

Building (167,000 ft3 - 4730m3)

Chlorine Dioxide Gas has good material compatibility

For example……..

143

Various Equipment

144

Automated Guided Vehicle (AGV)


25

145

Various Equipment

146

Various Equipment

147

Various Equipment

148

Various Equipment

149

Workstation Isolator (350 ft3 - 10m3)

150

AmgenThousand Oaks, CA

Filling Line Isolator (250 ft3 - 7m3)


26

151

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

152

Rigid Isolator (100 ft3 - 2.8m3)

153

Summary

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, BSC’s, HEPA Housing, Duct

work, isolators, suite of rooms, etc)

Sterilant process

EPA Approved process

NSF Approved process

154

Example Application Data

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.

155

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

• All the treatments were for 10 min at 20oC.

0

1

2

3

4

5

6

7

8

9

Lo

g R

ed

ucti

on

s

Uninjured Surface

Injured Surface

Water

Washing

3 mg/l ClO2Gas

Treatment at 90% RH

3 mg/l ClO2

Solution Treatment

Aa

AcBy

Bx Ab

By

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

156

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

Untreated and stored for 6 weeks at 4oC

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


27

157

ControlControl

5 mg l5 mg l--11/2min/2min 5 mg l5 mg l--11/10min/10min

Day 9 at room temperatureDay 9 at room temperature

158

Prepared by:Mark A. CzarneskiDirector of TechnologyClorDiSys Solutions, Incwww.clordisys.com

PO Box 549 Lebanon, NJ 08833Phone: 908-236-4100Fax: 908-236-2222

e-mail: [email protected]

e-mail: [email protected]

159

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

160

Materials Compatibility Study

161

Conclusions of Purdue Materials Study• Metals

– No oxidation observed

– 316L, 304, Copper, anodized Al,

Novel metals

• Polymers


– PVC, Lexan, Epoxy, PP, Phenolic,

Urethane binders

– Siloxane gels absorbed/desorbed

• Electronics


– Contacts intact

• Incompatible with

– Cast aluminum

– Urethane foam

– Clear flexible urethanes

• Materials, materials, materials162

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


28

163

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°C for 7days

• Results

–No BI growth

• Data shared with HEPA Mfgs

– Interest in supplying sterilized filters

164

Colonization by Pseudomonas fluorescensCCL 134 of a hole in a PVCconveyor 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, 4015–4024.

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

PPM-Hrs Explanation

Standard CD Cycle isRH - 65% with 10 minutes of condition time CD Concentration - 1mg/L

CD Exposure time – 2 hrs

PPM calculation for 1mg/LPPM = (mg/M3) (24.45) / Molecular WeightPPM = (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 hrsExposure 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.

clordisys decontamination presentation

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