Rapid Decontamination Systems

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1 Rapid Decontamination Systems Brett Cole. Biosafety Pty Ltd Monday 11 th July 2016

2 Rapid Decontamination Systems: 1. Introduction 2. Why decontaminate? 3. The general rules for a successful decontamination (penetration, distribution, efficacy, adaptability) 4. Regulations and obligations Australian Standards, ISO, Dept of Health Services 5. Planning, Execution and Validation 6. The various common and emerging technologies used for rapid decontamination and sterilization 7. Case Studies 8. Conclusion 9. Questions

3 Professional Experience- Bachelor of Science with Honours Degree Microbiology (Monash University) Masters Degree in Occupation Hygiene and Toxicology (Edith Cowan University) Over 15 Years experience in Infection, Waste and Contamination Control (Healthcare, Pharmaceutical and Laboratory) Committee Member of ABSANZ Regulatory Committee (OGTR, DAFF and AS/NZS) Member of Australia Institute of Occupational Hygiene (MAIOH) Member of Australian Standards Committees (CH-029) Safety in Laboratories Standards Licensed Fumigation Company (Dept of Health and Human Services) Member of ANZLAA, ABSANZ, SCRIA, ISPE and ACPIC

4 Why Decontaminate? To create a Sterile baseline Renovation (Before or after) Between Population / Production Batches Commissioning De-Commissioning Contamination/Infection Preventative Maintenance Regulatory compliance GMP/Best Practice Other

What makes for a good 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.

5 What makes for a good 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 5. At required Environmental conditions (temp/rh) Any decontamination method requires a complete and thorough distribution of the sterilant or high level liquid disinfectant to get an effective decontamination or kill

6 What makes for a good decontamination? Other considerations: Containment of fumigant Disposal of fumigant via ventilation, neutralization, Filtration/Scrubbing Material compatibility Safety all fatally toxic at use concentrations Regulatory compliance

7 Microbial Resistance

8 Types of Antimicrobial applications: 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. (Log 6 Reduction) 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. (Log 4 Reduction) 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. (Log 2 Reduction) 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).

9 Size comparisons Organism sizes vs. droplet/molecule Showing the tight areas where organisms can hide, this is a scratch in stainless steel which is harboring bacteria

10 Compliance Compliance with: Australian Standards AS/NZS Safety in Laboratories Microbiological Containment (Update out for public comment) AS/NZS 2252 Controlled Environments AS 2467 General Requirements for Fumigation OGTR PC3 and 4 Regulations DAWR (AQIS) QC 2 and 3 Requirements ISPE/ISO Regulations (Pharmaceutical) Good Manufacturing Practice (GMP) Licensed Fumigation Company (Dept of Health and Human Services etc) Required Validation Methods for successful decontamination

decontaminating agent (Best fit-for-purpose) Establish the schedule and ordering Write SOPs, fumigation management plan (AS 2467 24 hour

11 Planning for decontamination Define purpose and scope: rooms, equipment, HVAC Identify the players, area production managers, OH&S, facilities engineering, QC validation, security, emergency services, other facility users Establish responsibilities (SWMS, SOP, Who s who) Select decontaminating agent (Best fit-for-purpose) Establish the schedule and ordering Write SOPs, fumigation management plan (AS hour notification) Define validation: BIs, full PQ, target dosage Hand back procedure References: Harris (2010)B & V Testing, INC. AS 2467 (2008) General Requirements for Fumigation

perimeter/signage Introduce chemical and bring to target concentration for target exposure time; monitor Monitor

12 Planning for decontamination: Execution of the process Prepare area; pre-clean, BI placement, fan, distribution, monitor readiness, seal area, safety perimeter, signage Reach target temp/humidity; monitor Create safety perimeter/signage Introduce chemical and bring to target concentration for target exposure time; monitor Monitor surrounding areas for leakage Ventilate and/or neutralize to below OEL Incubate/analyze BIs as specified Provide reporting as required

13 Rapid Decontamination Systems: Formaldehyde Ozone (Cold Plasma/UV Generated) Vapourised Hydrogen Peroxide Ionised Hydrogen Peroxide Chlorine dioxide

14 Formaldehyde : Decontamination Parameter Description Technology Manufacturer Delivery Method Target concentration required for 6-log reduction NA Frypans??? NA In room hot plate method 0.3g of paraformaldehyde per cubic foot of volume (NSF 49 Annex G) ppm Typical Cycle Condition Charge Dwell Neutralisation - Aeration Typical Cycle Length (BSC/Isolator) Overnight Typical Cycle Length (Room 250m 3 ) Biological Indicators Used Other validation methods hours Typically NA

15 Formaldehyde: Benefits: Scalable (just add more hot plates 1000cu ft / hot plate) Inexpensive True Gas (boiling point -19 o C) Requires RH 65+% Carcinogen (USDHHS & 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 At the end of exposure neutralization is done using ammonia bicarbonate Challenges: Long Contact times (6-12 hours) Requires high concentrations to achieve sporicidal effects ( ,000 ppm) Leaves Residue and Carcinogenic

16 Ozone Decontamination Parameter Description Technology Manufacturer Delivery Method Target concentration required for 6-log reduction Typical Cycle Typical Cycle Length (BSC/Isolator) Cold Plasma/UV Generated (185nm) NA In room up to 70 ug/ml Condition Charge Dwell - Aeration NA Typical Cycle Length (Room 250m 3 ) Biological Indicators Used Other validation methods hours Geobacillus stearothermophilus Chemical O3 Monitoring

Ozone Benefits Person removed from the process (Safety) True Gas at room temp (boiling point -112 o C) Low cost equipment No post exposure cleanup required Challenges Generators do not generate

17 Ozone Benefits Person removed from the process (Safety) True Gas at room temp (boiling point -112 o C) Low cost equipment No post exposure cleanup required Challenges 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 efficacy 1 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 , Dec hours exposure 1000ppm 4.3log reduction of spores with high RH >80%

18 Vapourised Hydrogen Peroxide: Decontamination Parameter Description Technology Manufacturer Delivery Method Target concentration required for 6-log reduction Typical Cycle Typical Cycle Length (BSC/Isolator) VHP Steris Corporation - USA Vapourisation (via heat plate) or microdroplet through high airflow 35 or 59% Hydrogen peroxide (Reagent) ppm Target Concentration Condition Charge Dwell - Aeration 45 minutes Typical Cycle Length (Room 250m 3 ) 4-6 hours depending on conditions (temp/rh) Biological Indicators Used Other validation methods Steris NA333 biological indicators hours incubation time, stainless steel coupon Geobacillus stearothermophilus Real time H202 room concentration

Vapourised Hydrogen Peroxide : Benefits: Clean and simple to use. By products water and oxygen. Real time room conditions are measured for fully validated cycles with print outs.

19 Vapourised Hydrogen Peroxide : Benefits: Clean and simple to use. By products water and oxygen. Real time room conditions are measured for fully validated cycles with print outs. Integration with facility HVAC is possible. High efficacy at low concentrations. Full SAT validation for pharmaceutical or GMP applications. Challenges: Expensive equipment compared with other methods.

20 Vapourised Hydrogen Peroxide: Case Study: High Containment Laboratory: Krishnan et al (2006) 85m 3 (3000 cubic feet) Open room with two BSC/Isolators Dry Cycle (Humidity brought down to 40%) Cycle time = 200 minutes (3.3 hours) not including aeration Aeration took 24 hours Complete Kill was achieved (6-log reduction) Suitable alternative to formaldehyde

21 Vapourised Hydrogen Peroxide Decontamination Parameter Description Technology Manufacturer Delivery Method Target concentration required for 6-log reduction Typical Cycle Typical Cycle Length (BSC/Isolator) Typical Cycle Length (Room 250m 3 ) HPV Bioquell - UK Flash Evaporation of Peroxide and high velocity distribution (Mobile In Room generators as well as Semi-fixed and Fixed decontamination solutions via hoses/pipework) 30 to 35% Hydrogen peroxide (Reagent) The amount of HPV required to achieve >6log reduction is dependent on a number of factors such as enclosure size and starting conditions, hence PPM concentration is not used as a target to determine cycle efficacy. Bioquell offers both Parametric gassing cycles and Timed gassing cycles for GMP, validated through the use of biological and chemical indicators. Condition Charge Dwell - Aeration Under 60 minutes. Cycle time can be decreased with additional generators. 24 hours including set up and pack up (2200m3 room) Biological Indicators Used Other validation methods Bioquell HPV-BI Biological Indicator Type: 6-log Geobacillus stearothermophilus ATCC Bioquell Chemical Indicators

22 Vapourised Hydrogen Peroxide Benefits: Residue Free Excellent Material Compatibility, Fast, Safe (only by-products are water vapour and oxygen) Proven research based efficacy against a broad spectrum of biological contaminants (see published Bioquell s efficacy document) GMP Compliant Challenges: Often confused with low concentration aerosolised hydrogen peroxide systems

23 Vapourised Hydrogen Peroxide Case Study: Laboratory: Bioquell Published Project 2200m 3 Multiple Machines used Complete Process in less than 24 hours Complete Kill was achieved (6-log reduction)

24 Ionised Hydrogen Peroxide: Decontamination Parameter Description Technology Manufacturer Delivery Method Target concentration required for 6-log reduction Typical Cycle Typical Cycle Length (BSC/Isolator) Ionised Hydrogen Peroxide (IHP) TOMI Inc - USA In room 7% Hydrogen peroxide ionised at 17K Volts (Reagent) ppm Target Concentration Condition Charge Dwell - Aeration 60 minutes Typical Cycle Length (Room 250m 3 ) 4-6 hours depending on conditions (temp/rh) Biological Indicators Used Other validation methods Steris NA333 biological indicators hours incubation time, stainless steel coupon Geobacillus stearothermophilus Real time H202 room concentration using Draeger H2O2 Meter

25 Ionised Hydrogen Peroxide Benefits: Clean and simple to use. By products water and oxygen. Scalable (each unit can do 35m3 and three systems can do up to 105m3) Easily Transportable Challenges: None noted

26 Chlorine dioxide gas: Decontamination Parameter Description Technology Manufacturer Delivery Method Target concentration required for 6-log reduction Typical Cycle Typical Cycle Length (BSC/Isolator) Chlorine dioxide gas (ClO 2 or CD) ClorDiSys Solutions - USA Dry Gas introduced from outside target area 1 mg/l (Reagent) or 360 ppm 720 ppm.hours Standard Cycle Condition Charge Dwell - Aeration 85 minutes Typical Cycle Length (Room 250m 3 ) Biological Indicators Used Other validation methods 2-4 hours depending on conditions (temp/rh) NAMSA Tyvek Strip in Tyvek Envelope Geobacillus stearothermophilus 36 hours incubation Real time Cl0 2 room concentration

Chlorine dioxide gas: Benefits: Dry gas process - No residue Scalable (one machine does up to 1983m3) Real time room conditions are measured for fully validated cycles with print outs

27 Chlorine dioxide gas: Benefits: Dry gas process - No residue Scalable (one machine does up to 1983m3) Real time room conditions are measured for fully validated cycles with print outs (GMP compliant) Able to penetrate HEPA filters Rooms, BSC, Isolators, HVAC are able to done at same time Fastest Process Challenges: Expensive equipment compared with other methods Oxidiser

28 Chlorine dioxide gas Case Study: PC3 Laboratory: Griffith University Glycomics Facility 276m 3 Multiple rooms with BSC s Cycle (Humidity raised to 65%) Cycle time = 180 minutes (3 hours) including aeration Aeration took less than 1 hour Complete Kill was achieved (6-log reduction) Complete project completed in 7 hours (set up to pack up)

29 Comparisons between technologies Key H 2 O 2-1 = Wet VHP Process H 2 O 2-2 = Fogging Process H 2 O 2-3 = Dry VHP Process

30 Comparisons between technologies Key H 2 O 2-1 = Wet VHP Process H 2 O 2-2 = Fogging Process H 2 O 2-3 = Dry VHP Process

31 Biosafety Case Studies

32 32 Case Study: BioSperix Cell Isolator: PC2 Suite 1 x Biosperix Isolator Equipment: 1 x Generator, 1 x Carbon Scrubber Total Cycle Time = 4 hours

33 33 Case Study: BioSperix Cell Isolator

physical clean, ISO 14644-1 Validation and

34 34 Case Study: Facility Handover - Cyclotron Facility Three Areas with GMP Critical Areas with 3 stage physical clean, ISO Validation and Sterilization Total Project Duration = 6 days (1 day for decontamination)

35 35 Case Study: Facility Decontamination Redundant Penicillin Facility Facility with 2 stage physical clean and Inactivation using Chlorine dioxide gas Total Project Duration = 8 days (6 days prep, 1 day gas, 1 day aeration)

36 36 Case Study: Facility Decontamination Redundant Penicillin Facility

37 37 Case Study: Facility Decontamination Redundant Penicillin Facility

clean and pinworm egg Inactivation using Chlorine

38 38 Case Study: Facility Decontamination Animal Facility Pinworm Outbreak Facility with single stage physical clean and pinworm egg Inactivation using Chlorine dioxide gas Total Project Duration = 7 days (6 day clean, 1 day gas)

39 39 Case Study: Facility Decontamination Animal Facility Pinworm Outbreak

40 Case Study: Facility Decontamination New PC3 Facility Griffith University Glycomics (~800m 3 over two levels) Facility Decontamination using Chlorine dioxide gas Total Project Duration = 2 days (Day 1 General PC3, Day 2 Animal) including BSC, Ante Room and HEPA Housings

41 Case Study: Facility Decontamination New PC3 Facility Griffith University Glycomics

42 Summary: Decide Why you are decontaminating and what level of decontamination you require (6-log, 4-log etc) Viable alternatives to formaldehyde gas exist for efficacious and safe decontamination of pharmaceutical production areas and isolators/bsc Understand the physical properties and behaviour of your decontaminant of choice to ensure efficacy and safety Different decontaminants may be appropriate for different applications All decontaminants have benefits and challenges All decontaminants are dangerous to humans. They are all designed to kill Planning and safety are the two most important aspects of successful decontamination

43 Acknowledgements: I would like to acknowledge of the following people for assisting in compiling the information on the various technologies: Mr Brendan Edwards (Allied Scientific) VHP Steris Corporation Mr Bernie Crampsie (Biodecon Solutions) VHP Bioquell Mr Darren Spittal (LAF Technologies) IHP Sterimist Mr Mark Czarneski (ClorDiSys Solutions) Chlorine dioxide gas

44 ANY QUESTIONS? Thank you for your time! Please feel free to me at

Cleanroom Contamination including Mould/Fungal contamination

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