Material Compatibility of Chlorine Dioxide Gas – Paul Lorcheim
Transcription
Material Compatibility of Chlorine Dioxide Gas – Paul Lorcheim
Material Compatibility Of Chlorine Dioxide Gas Paul Lorcheim, PE Director of Operations Decontaminating the Difficult Since 2001 Worlds Largest Supplier of Gaseous Chlorine Dioxide Decontamination Equipment and Services 1 Revision Date: June 22, 2008 Overview 1. When, Where, Why ? 2. Define Chlorine Dioxide 3. Comparisons (CD vs. others) 4. Define Chlorine Dioxide Sterilization Parameters 5. CSI CD Generation Equipment /Services 6. Exploration of Applications 2 When To Use Chlorine Dioxide Gas Renovation Between Population / Production Batches Commission De-Commissioning Contamination Preventative Maintenance ….. 3 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 4 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. 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 5 Chemical Attacks in the Civilian Sector” SCIENCE VOL 302 #21 NOVEMBER 2003 pp1350-1354. 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. 6 Chlorine Dioxide Time Line Aqueous Germicide (Drinking Water Treatment Longest User) 1920 Chlorine Dioxide Recognized as a Gaseous Chemosterilizing Agent 1984 CSI CD-Cartridge Registered with US-EPA Mar 2004 Time 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 lb’s / hour (1.4kg / hour)of CD to be emitted 2004 Ontario reported releases of 114 tonnes (103,419kg) CD is not listed in the California Air Pollution Control Officers Association Air Toxics "Hot 7 Spots" Program Revised 1992 Risk Assessment Guidelines as having health values (cancer or non-cancer) for use in risk assessments (CAPCOA, 1993)CD 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 8 Decontamination Methods 1. Spray and Wipe / Fogging - Various 2. Ethylene Oxide Gas – Non-oxidizer 3. Vapor Phase Hydrogen Peroxide (VPHP) – Oxidizer 4. Ozone Gas – Oxidizer 5. Formaldehyde Gas – Non-oxidizer 6. Liquid Chlorine Dioxide – Oxidizer 7. Chlorine Dioxide Gas – Oxidizer 9 Myth of Corrosion 10 Oxidation Potential of Several Biocidal Agents 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 More Corrosive Biocidal Agent Oxidation Capacity (electrons) 2e– 2e– 2e– 2e– 5e– 1 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. Wintner, Barry, Contino, Anthony, O’Neill Gary, (2005) Chlorine Dioxide, Part 1 A Versatile, High-Value Sterilant for the Biopharmaceutical Industry, BioProcess International 3(11) 11 Gaseous CD is not the same as Liquid CD Liquid CD creates the chlorine dioxide through acidification of sodium chlorite Common Liquid Generation Methods: sodium chlorite + water + acid = 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 12 CD does NOT form Hydrochloric Acid ClO2 dissolves in water ClO2 is water soluble Water Droplets: ClO2 does NOT dissociate in water ClO2 does NOT hydrolyze in water After 5 runs each at 5mg/L for 7 hours 88 equivalent runs ClO2 does NOT react with water ClO2 does NOT NOT NOT form hydrochloric acid Salt dissociates in water NaCl(s) --> Na+(aq) + Cl-(aq) Chlorine forms hydrochloric acid Cl2 + H2O --> HCl + HOCl 13 Outside Testing 14 Material Compatibility EPA Comparison of Decon Agents Snyder, Emily, “Indoor and Outdoor Decontamination” Presentation at EPA Region 9 / ORD Homeland Security Research Workshop, July 14, 2011 San Francisco, CA. Accessed from http://www.epa.gov/osp/presentations/homesec11/hs_Snyder1.pdf . Accessed on 1-10-2013 15 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 16 Materials Compatibility Study 17 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 – Urethane foam – Clear flexible urethanes 18 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 19 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 No degradation to filter, glue, or seals with CD 20 Contract Sterilization Examples Contract Sterilization is the process where ClorDiSys can decontaminate / sterilize your items, equipment, supplies, and products at our facility and then ship them back to you (or someone else). It can be returned under sterile conditions or just decontaminated. ClorDiSys uses chlorine dioxide gas for sterilization of components instead of gamma irradiation, ethylene oxide gas, or electron beam methods. 21 Example: Items in Isolator Chamber 22 Example: Items in Isolator Chamber 23 Example: Medical Device Components 24 Example: Printers and computers 25 Example: Electronic Product 26 Material Compatibility Formaldehyde VPHP CD Electronics Very Good1 Good2 Good2 Equipment Very Good1 Good2 Good2 Wall Paint Good3 Good4 Condensation bubbles paint Good4 Floor Paint Good3 Good4 Condensation bubbles paint Good4 Ductwork (Galvanized) Very Good1 ?5 Good2 Ductwork (SS) Very Good1 Good2 Good2 1. Formaldehyde can leave residues without actually causing material damage 2. All are oxidizers which have the potential to cause oxidation 3. Formaldehyde can leave residues and leave brown stains 4. Potential slight yellowing of urethane based paints 5. Galvanized metal breaks down VPHP 27 Safe On Materials! Chlorine dioxide gas is safe on most materials, including stainless steel, anodized aluminum, painted steel, plastics, gasket materials, and electronics. Material testing is available for new items / materials 28 What is the Process? 29 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 30 Example Applications: 31 Example Application: 32 65 Room (180,000 ft3 – 5097 m3) New Animal Facility Initial Decontamination Service 10 Injection Locations 7 20 Sensor Locations 3 4 4 2 6 8 10 5 8 1 9 20 18 6 5 9 16 15 10 19 3 12 14 2 17 1 7 13 11 33 65 Room New Animal Facility Chemistry Labs 34 65 Room New Animal Facility Changing Stations and BSC’s 35 65 Room New Animal Facility Storage Rooms 36 65 Room New Animal Facility Animal Holding Rooms 37 Sterilization of Juice Storage Tank with Piping 38 Sterilization of intermodal transportation containers 39 Spiral Freezers “We swab intensely every weekend and we have been totally clean! This has definitely been a success “ 40 Spiral Freezer Positive swabs for Listeria spp. Decontaminated a ~25,000 ft3 spiral freezer with CD gas (720 ppm-hrs) Continual swabbing 2-3 times/day for 6 weeks after treatment without Listeria spp. Decontamination Area Photo High Ceilings (90ft - 27.4m) 42 Decontamination Area Photo High Ceilings (90ft - 27.4m) 43 . Decontamination Area Photo High Ceilings (90ft - 27.4m) 44 . High Ceilings (100ft – 30.5m) 45 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. 46 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) Mix-fill, measuring and packaging process Isolators Lyophilizers (Freeze Dryers) 3 hour cycle CD cycle run every 2 weeks Old steam cycle 24 hours with heat up /cool down time Filling Line Isolator (250 ft3 - 7m3) Amgen Thousand Oaks, CA 50 Microbial Challenge Room (6000 ft3 - 170m3) Example of Good Material Compatibility 51 Decontamination Chambers 52 IVC Rodent Racks 53 Portable Decontamination Chamber 54 Transport / Delivery Vehicles 55 BI Location Inside Open and Closed Cabinets Both BI’s Killed Example of EXCELLENT Penetration Ability BI Placed in OPEN Cabinet 56 BI Placed in CLOSED Cabinet BI Location Under Equipment Example of EXCELLENT Penetration Ability Both BI’s Killed BI Placed UNDER Equipment 57 BI Location Under Equipment Example of EXCELLENT Penetration Ability BI Placed UNDER Equipment 58 BI Location Between Components Example of EXCELLENT Penetration Ability Both BI’s Killed BI Placed Between Components 59 BI Location In Cage In Ventilated Rack Both BI’s Killed Photos 60 HEPA Housing 61 BSL-3 Suite 62 Sterilizing Filters (mounted incorrectly) 63 Equipment Decontamination 64 Necropsy Rooms 65 Surgical Suite (2000 ft3 - 56.6m3) Example of Good Material Compatibility 66 Passthrough Rooms 67 Passthrough Rooms (325 ft3 - 9.2 m3) 2.5 hr cycle time 68 Pass Through Room (864 ft3 - 24.5m3) Example of Good Penetration Ability 69 Lumen Sterilizer Load (Total Sterilization Cycle Time - 3 hour 40 minutes) Example of Good Penetration Ability 70 Aseptic Juice Filling Room 115 sq m (20,000 ft3 – 566.3 m3) 71 Pharmaceutical Aseptic Filling Suite 15,000 ft3 (424m3) Location: Major Pharmaceutical Manufacturer in Korea 72 Pharmaceutical Chemistry Lab 160 sq m (17,000 ft3 - 481 m3) 73 Process Tanks and Piping Example of Long Distances True Gases Can Travel 74 Building (167,000 ft3 - 4730m3) University of Pennsylvania Bolton Center Kennett Square, PA 75 Various Equipment 76 Automated Guided Vehicle (AGV) 77 Control Room with computers & Equipment 78 Transmission Cryo-Electron Microscope (JEOL Cryo-TEM) $3,000,000 “Our early attempts to use VHP with JEOL microscopes were not successful because of unacceptable level of corrosion … …We therefore selected ClO2 (CD) for the microscope decontamination.“ Minidox – M Gaseous Chlorine Dioxide Decontamination Machine Sherman, Michael B., Trujillo, Juan, Leahy, Ian, Razmus, Dennis, DeHate, Robert, Lorcheim, Paul, Czarneski, Mark A., Zimmerman, Domenica, Je T’Aime M. Newton, Haddow, Andrew D. and Weaver, Scott C., “Construction and organization of a BSL-3 cryo-electron microscopy laboratory at UTMB”, Journal of Structural Biology 181 (2013) 223–233. Various Equipment 80 Various Equipment 81 Various Equipment 82 Various Equipment 83 Various Equipment 84 Various Equipment 85 Workstation Isolator (350 ft3 - 10m3) 86 Flexible Isolators (25-30 ft3 - 0.7-0.8m3) 87 Rigid Isolator (100 ft3 - 2.8m3) 88 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) EPA Approved Sterilant process NSF Approved process Compatible with materials typically found in a Research or Production Facility 89 Compatible with Fresh Strawberries too! 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 90 monocytogenes on strawberry by chlorine dioxide gas, annual meeting of Institute of Food Technologists, Anaheim, CA, 2002. Prepared by: Paul Lorcheim, PE Director of Operations ClorDiSys Solutions, Inc www.clordisys.com PO Box 549 Lebanon, NJ 08833 Phone: 908-236-4100 Fax: 908-236-2222 E-mail: [email protected] Decontaminating the Difficult Since 2001 91 • All the treatments were for 10 min at 20oC. Aqueous and Gaseous ClO2 vs. Washing for Reducing L. monocytogenes on Peppers 9 Log Reductions 8 Aa Uninjured Surface 7 Injured Surface 6 5 Bx Ab 4 3 2 By 1 Ac By 0 3 mg/l ClO2 Gas Treatment at 90% RH 3 mg/l ClO2 Solution Treatment Water Washing (Han, Y. et al, Reduction of Listeria monocytogenes on Green Peppers (Capsicum annuum L.) by92 Gaseous o and Aqueoous Chlorine Dioxide and Water Washing and Its Growth at 7 C, Journal of Food Protection, Vol 64, No 11, 2001 pages 1730-1738) 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 93 CD is the Safest Fumigant CD VPHP / IHP Formaldehyde Ozone (time weighted average) 0.1 ppm ☹ 1.0 ppm ☹ 0.5ppm EU 0.75 ppm ☹ 0.1ppm ☹ Typical Concentrations 360 ppm ☺ 750 ppm ☹ 8000 ppm ☹ 20-1000ppm ☺ NO ☹ YES ☺ NO ☹ 3-4 hours ☺ 6-12 hours ☹ 12+ hours ☹ 6-72 hours ☺ NO - ACGIH ☺ NO - OSHA☺ YES – ACGIH ☹ NO – OSHA ☺ YES ☹ No ☺ YES ☺ YES ☺ NO ☹ Yes ☺ Penetration & Distribution YES (gas) ☺ NO (Vapor) ☹ YES (gas) ☺ Yes (gas) ☺ Penetrate Water YES (gas) ☺ NO (Vapor) ☹ YES (gas) ☺ Yes ☺ Outside room☺ Bioquell Inside ☹ / Steris Outside room Inside Room ☹ Inside and Outside Room ☺ 30-60 min☺ overnight ☹ 1 hour + cleanup 30-6094 min ☺ OSHA 8 hr TWA Odor Detection Cycle Times (Risk of Exposure) Carcinogen Vented to Environment Equipment Location Aeration Time CD is the fastest to the TWA 8hr threshold YES ☺ At 8 hour safety level ☺ ☹
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