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Understanding Decontamination SOPs Cleaning + Disinfection = Decontamination.

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Presentation on theme: "Understanding Decontamination SOPs Cleaning + Disinfection = Decontamination."— Presentation transcript:

1 Understanding Decontamination SOPs Cleaning + Disinfection = Decontamination

2 Overview SOPs SOPs Compliance Compliance Order of Disinfection Order of Disinfection Typical SOPs Typical SOPs Disinfectants Disinfectants Types and properties Types and properties Strengths & weaknesses Strengths & weaknesses Application techniques Application techniques Wipers Wipers Mops Mops Fogs Fogs Residue Residue Contact times Contact times Compliance Compliance Common Questions & Issues Common Questions & Issues Summary Summary

3 SOP Compliance Relies On Proper Use SOPs list specific Sanitizers, Disinfectants and Sterilants SOPs list specific Sanitizers, Disinfectants and Sterilants Each type of chemical is optimized for a different task Each type of chemical is optimized for a different task All liquid disinfectants rely on intimate contact with the surface All liquid disinfectants rely on intimate contact with the surface SOP compliance is very dependent on operators SOP compliance is very dependent on operators

4 General Order Of Disinfection Disinfect ceilings and walls Disinfect ceilings and walls Clean the area (line clearance) Clean the area (line clearance) Disinfect equipment (if applicable) Disinfect equipment (if applicable) Rinse or IPA wipe down of equipment Rinse or IPA wipe down of equipment Disinfect floors Disinfect floors Allow to air dry Allow to air dry Once a month clean and rinse all surfaces Once a month clean and rinse all surfaces

5 Typical Cleaning SOP Multiple times/day: Sterile IPA on work surfaces and a disinfectant cleaner such as Vesphene or LpHse on the floors Multiple times/day: Sterile IPA on work surfaces and a disinfectant cleaner such as Vesphene or LpHse on the floors Weekly: Complete cleaning with germicide on ceilings, walls and floors Weekly: Complete cleaning with germicide on ceilings, walls and floors Monthly or when action levels call for it: High level sterilants used for complete cleans Monthly or when action levels call for it: High level sterilants used for complete cleans

6 Bleach / H 2 O 2 / Peracetic Acid (Spor-Klenz) Phenolics (LpH, Vesphene) Peroxide and Quats Process NPD, Biocide A & B Alcohols Increased Microbial Efficacy and/or Regulatory Claims Ease of Use Hierarchy of Disinfectants

7 Sanitizers vs. Disinfectants vs. Sterilants Chemical Type Sanitizers(Sterile Alcohol) Sanitizers(Sterile Alcohol) Disinfectant Cleaners (Low or Intermediate level Germicides) Disinfectant Cleaners (Low or Intermediate level Germicides) Sterilants (High Level Germicides) Sterilants (High Level Germicides) Functionality Offers 2 log reduction, no impact on spores and no residue. Offers 5 log reduction on a soiled surface with moderate residues. 5 log reduction and spore control on clean surfaces. High residues.

8 Class Recommended Use How They Work AdvantagesDisadvantages Comments & Hazards Examples 70% Isopropyl Alcohol solution -Cleaning some instruments -Cleaning skin -General purpose sanitizer for clean room equipment and work surfaces -Changes protein structure of microorganism -Presence of water assists with killing action -Very low in residue-filtered, sterile IPA very expensive High VOCs and poor cleaning when sprayed on the surface -Not active when organic matter present -Not active against certain types of viruses -Evaporates quickly -Contact time not sufficient for killing -Flammable -Eye Irritant -Toxic - Sterihol Chlorine Compounds -Spills of human body fluids Bactericidal - Good Fungicidal - Good Sporicidal - Good at >1000ppm Sodium Hypochlorite -Free available chlorine combines with contents within microorganism, reaction byproducts cause its death -Need 500 to 5000 ppm -Produce chemical combination with cell substances -Depends upon release of hypochlorous acid -Kills hardy viruses (e.g. hepatitis) -Kills a wide range of organisms -Inexpensive -Penetrates well -Relatively quick microbial kill -May be used on food prep surfaces -Corrodes metals such as stainless, aluminum -Organics may reduce activity -Increase in alkalinity decreases bactericidal property -Unpleasant taste and odor -Tuberculocidal, with extended contact time -heavy residues -Follow spill procedure and dilution instructions -Make fresh solutions before use -Eye, skin and respiratory irritant -Corrosive -Toxic -Bleach solutions (sodium hypochlorite) -Clorox -Cyosan -Purex -NaDCC (sodium dichloro- isocyanurate) Summary & Comparison Of Liquid Disinfectants Compiled by University of Virginia

9 Class Recommended Use How They Work AdvantagesDisadvantages Comments & Hazards Examples Peroxide/ Peroxide & Peracetic Acid General Housekeeping Bactericidal - Very Good Fungicidal - Excellent Virucidal – Excellent Spores- good with extended contact times -30 minutes -disrupts cell walls -Kills broad range of organisms -Low residues -5 minute contact time for Broad Spectrum -Not affected by hard water Good safety and Environmental profile -Peroxide easily inactivated by organic residues -Peroxide/Peracetic acid limited penetration of residue laden surfaces -Pre-cleaning a requirement Peracetic acid/hydrogen peroxide hard to use due to unstable solution -Klercide CR Biocide C -Spor-Klenz Phenolic Compounds Bactericidal - Excellent Fungicidal - Excellent Tuberculodial - Excellent Virucidal - minute contact times -Gross protoplasmic poison -Disrupts cell walls -Precipitates cell proteins -Low concentrations inactivate essential enzyme systems -Nonspecific concerning bactericidal and fungicidal action -Vesphene/LpH formulated with cleaning surfactants -Unpleasant odor -Some areas have disposal restrictions -Effectiveness reduced by alkaline pH, natural soap or organic material -Sporicidal, no High residues -Skin and eye irritant -Sensitizer -Corrosive -Toxic -Hil-Phene -Lph -Metar -Vesphene Quaternary Ammonium compounds (QUATS) -Ordinary housekeeping (e.g. floors, furniture, walls) Bactericidal - Excellent Fungicidal - Good Virucidal - Good (not as effective as phenols) -Affects proteins and cell membrane of microorganism -Releases nitrogen and phosphorous from cells -Contains a detergent to help loosen soil -Rapid action, 5 minute contact times -Colorless, odorless -Non-toxic, less corrosive -Highly stable -May be used on food prep surfaces -spores not eliminated by all brands, TB bacteria, some viruses -Effectiveness influenced by hard water -Layer of soap interferes with action -high in residues -Select from EPA list of hospital disinfectants -Skin and eye irritant -Toxic -Biocide B has good spore activity w/15 minute contact times -Coverage 258 -End-Bac -Hi Tor -Klercide-CR Biocide A & B Summary & Comparison Of Liquid Disinfectants…cont. Compiled by University of Virginia

10 Sanitizing Agents/Sterile Alcohol Strengths Low Residue Signature Low Residue Signature Quick Drying Quick Drying Good Cleaning Performance if applied to wiper Good Cleaning Performance if applied to wiper Weaknesses Hard to apply evenly in sufficient volume Very expensive (>when Sprayed to surface) High VOCs (>when sprayed to surface) Poor removal of disinfectant residue

11 Sterile Alcohol/In Use Reality SOP Objective Sanitize surfaces by removing residues and particles that harbor micro-organisms Sanitize surfaces by removing residues and particles that harbor micro-organisms Rinse surfaces of disinfectant residues Rinse surfaces of disinfectant residues SOP Compliance Issue Current wipers make it difficult to wet the entire surface. Operator to operator non- uniformity To achieve even minimal contact times surfaces are sprayed, then wiped Bleach, Phenolic and Quat residues are not easily removed.

12 Low Level Germicides (Quats)/ Biocide A & B, Coverage Plus Strengths Bactericidal and Fungicidal Bactericidal and Fungicidal Some Virucidal activity Some Virucidal activity Non Corrosive and non irritating Non Corrosive and non irritating 5-15 minute contact times 5-15 minute contact times Weaknesses Not Sporicidal and No TB Medium Level of residue Poor cleaning action against biofilms

13 Intermediate Level Germicides (Phenolics/Vesphene, LpH ) Strengths Broad level activity- Virucidal, Bactericidal, Fungicidal &Tuberculoid Broad level activity- Virucidal, Bactericidal, Fungicidal &Tuberculoid Maintains activity on soiled surfaces Maintains activity on soiled surfaces Good cleaning action on soiled surfaces Good cleaning action on soiled surfaces Weaknesses No Spores High residue levels Minimum 10 minute contact time Operator Safety Issues

14 Intermediate Level Germicides(H 2 O 2 /Biocide C) Strengths Fast acting Fungicidal, Virucidal & Bactericidal Fast acting Fungicidal, Virucidal & Bactericidal 15 minutes 15 minutes No residues No residues Good safety profile Good safety profile Weaknesses Must be used on a clean, residue free surface No cleaning ability

15 Germicides/Disinfectant Cleaners- The Real World SOP Objective Achieve 5 log reduction on clean room surfaces Achieve 5 log reduction on clean room surfaces Effective use depends on removing residue buildup Effective use depends on removing residue buildup SOP Compliance Issues Microbial reductions rely on achieving label indicated contact times times which are very difficult to achieve with mopping or wiping in high air flow rooms Rinse protocols are not easily met Mopping & Wiping are very operator dependent

16 High Level Germicides Bleach/Spor-Klenz Strengths Broad Level activity including Spores Broad Level activity including Spores H /Peracetic acid/ Spor-Klenz are fast acting (5 minute contact times for some organisms) H /Peracetic acid/ Spor-Klenz are fast acting (5 minute contact times for some organisms) Weaknesses Long contact times required for spores Bleach has high residue levels and is very corrosive Bleach is a poor cleaner and presents safety issues H 2 O 2 /Paracetic acid is concentration dependent so hard to use

17 High Level Germicides/Sterilants In use Reality SOP Objectives Eliminate spore contamination Eliminate spore contamination Residue levels must be low Residue levels must be low SOP Compliance Issues Bleach, especially is dependent on long contact times Pre-cleaning and rinsing steps are hard to complete Often used more frequently than desirable

18 Applying Disinfectants Via Spray Spray top to bottom Spray top to bottom Best wetting of the surface 7-10 minutes or longer Best wetting of the surface 7-10 minutes or longer Penetrates tight spots and rinses possibly existent contaminants Penetrates tight spots and rinses possibly existent contaminants Cleaning: power spray = not optimal Cleaning: power spray = not optimal Disinfection: light spray = excellent Disinfection: light spray = excellent Spraying alone does not clean the surface and residues and particulate can build up Spraying alone does not clean the surface and residues and particulate can build up Electrical issues need to be considered Electrical issues need to be considered

19 Applying Disinfectants Via Mopping Mop top to bottom with overlapping strokes Mop top to bottom with overlapping strokes Mopping is a mechanical action on the surface Mopping is a mechanical action on the surface This loosens particulate and residues which removes some of the contaminates This loosens particulate and residues which removes some of the contaminates While loosening and removing some, it does not remove all While loosening and removing some, it does not remove all Surface wetting is minimal and less than two minutes of contact time is typical Surface wetting is minimal and less than two minutes of contact time is typical

20 Applying Disinfectants Via Wipers Wipe in one direction back to front towards person Wipe in one direction back to front towards person Cleaning a surface should be done with a damp wipe that soaks up a chemical agent Cleaning a surface should be done with a damp wipe that soaks up a chemical agent Cleaning is not done with a saturated wipe as contaminants cannot be lifted from the surface Cleaning is not done with a saturated wipe as contaminants cannot be lifted from the surface Disinfection with a saturated wipe requires the wipe to be wetted and surface to be air dried Disinfection with a saturated wipe requires the wipe to be wetted and surface to be air dried Wipes need to be changed often Wipes need to be changed often

21 Applying Disinfectants Via Fogging Fog: 12 x 15 room – two foggers for at least two hours Fog: 12 x 15 room – two foggers for at least two hours Fogging for startup reduces the bioburden in the area Fogging for startup reduces the bioburden in the area Fogging is an excellent way to regain control of a corrupted area Fogging is an excellent way to regain control of a corrupted area Fogging needs to be done at a droplet size of 25 um (1-2 hours) or gap between droplets can occur Fogging needs to be done at a droplet size of 25 um (1-2 hours) or gap between droplets can occur Fogging requires a release time (2-3 hours) and does not clean – should be followed with a cleaning Fogging requires a release time (2-3 hours) and does not clean – should be followed with a cleaning Many types of Foggers Method for wet fog

22 Residues Can Be The Undefined Enemy Some SOPs specify residue levels on surfaces but some specify that the surface is clean Some SOPs specify residue levels on surfaces but some specify that the surface is clean Some residues do not show up on a white wiper Some residues do not show up on a white wiper Some SOPs call residue removal rinsing Some SOPs call residue removal rinsing

23 Contact Time=Wet Time Common misconception is that contact time is total time on the surface Common misconception is that contact time is total time on the surface QC and Management do not understand that operators often do not cover the entire surface QC and Management do not understand that operators often do not cover the entire surface Actually, contact time is the time the surface is wet Actually, contact time is the time the surface is wet Operator technique variations can affect contact times Operator technique variations can affect contact times

24 Typical Product Claims Sporicidal Agent Sterilant/Sporicidal [B. subtilis (ATCC 19659), Sterilant/Sporicidal [B. subtilis (ATCC 19659), C. sporogenes (ATCC 3584)] Bactericidal, Fungicidal, Virucidal undiluted 5-1/2 hours 20 o C Sporicidal – Non-porous Surfaces [B. Sporicidal – Non-porous Surfaces [B. subtilis (ATCC 19659), C. sporogenes (ATCC 3584)] undiluted 30 minutes 20 o C Broad Spectrum Disinfectant [S. aureus Broad Spectrum Disinfectant [S. aureus (ATCC 6538). S. enterica (ATCC 10708)] undiluted 30 minutes 20 o C Tuberculocidal (Mycobacterium bovis BCG) (Clinical Isolate) Mycoplasma gallispeticum (ATCC 15302) *HIV-1** (Clinical Isolate) *Minute virus of mice (Clinical Isolate) *Murine parainfluenza virus type 1 (Sendai) (ATCC VR-907) *Mouse hepatitis virus (Clinical Isolate)

25 Product Claims... Cont. Aspergillus niger (ATCC 16404) undiluted 5 minutes 20 o C Aspergillus niger (ATCC 16404) undiluted 5 minutes 20 o C Germicidal Spray Disinfectant [S. aureus (ATCC 6538), Germicidal Spray Disinfectant [S. aureus (ATCC 6538), S. enterica (ATCC 10708)] undiluted 5 minutes 20 o C Non-food Contact Surface Sanitizer [S. aureus Non-food Contact Surface Sanitizer [S. aureus (ATCC 6538), K. pneumonicae (ATCC 4352)] dilute 50X (1 part to 49 part water) for 5 minutes 21 o C

26 Decontamination Red Flags Overuse of sporicides Overuse of sporicides More frequently than validation indicated More frequently than validation indicated Visible cues - If the room doesnt look clean, it probably isnt Visible cues - If the room doesnt look clean, it probably isnt Stained windows Stained windows Stained tanks Stained tanks Sticky floors Sticky floors Frequency of passing alerts or action levels Frequency of passing alerts or action levels

27 Auditing Cleaning Practices Contact Times How are you meeting disinfectant label contact time requirements? How are you meeting disinfectant label contact time requirements? What are the contact times as specified by your SOP? What are the contact times as specified by your SOP? Are your practices consistent with your SOP? Are your practices consistent with your SOP? Are contact times being logged? Are contact times being logged?

28 Auditing Cleaning Practices Residues How are you removing disinfectant residues from equipment? How are you removing disinfectant residues from equipment? How are you improving your current practices to remove more residue? How are you improving your current practices to remove more residue? Are your cleanroom surfaces as clean as the coupons used to validate your disinfectants? Are your cleanroom surfaces as clean as the coupons used to validate your disinfectants?

29 Typical Compliance Issues SOP Issue Contact Times not being met or spraying required to meet contact times Contact Times not being met or spraying required to meet contact times High disinfectant residues High disinfectant residues Very frequent sporicide rotations Very frequent sporicide rotations Improved SOPs CoverMAX/PharmaMOP offer disinfection and cleaning in one step MiraWIPE and Microfiber mops Better cleaning and contact times may reduce the need to rotate in sporicides

30 Summary Having a robust decontamination SOP is critical Having a robust decontamination SOP is critical Improved disinfectant contact times are a major benefit Improved disinfectant contact times are a major benefit High residue levels are typical and difficult to handle High residue levels are typical and difficult to handle One step cleaning and disinfection is a significant improvement over current practices One step cleaning and disinfection is a significant improvement over current practices


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