2Overview Application techniques SOP’s Residue Disinfectants WipersMopsFogsResidueContact timesComplianceCommon Questions & IssuesSummarySOP’sComplianceOrder of DisinfectionTypical SOP’sDisinfectantsTypes and propertiesStrengths & weaknesses
3SOP Compliance Relies On Proper Use SOP’s list specific Sanitizers, Disinfectants and SterilantsEach type of chemical is optimized for a different taskAll liquid disinfectants rely on intimate contact with the surfaceSOP compliance is very dependent on operators
4General Order Of Disinfection Disinfect ceilings and wallsClean the area (line clearance)Disinfect equipment (if applicable)Rinse or IPA wipe down of equipmentDisinfect floorsAllow to air dryOnce a month clean and rinse all surfaces
5Typical Cleaning SOPMultiple times/day: Sterile IPA on work surfaces and a disinfectant cleaner such as Vesphene or LpHse on the floorsWeekly: Complete cleaning with germicide on ceilings, walls and floorsMonthly or when action levels call for it: High level sterilants used for complete cleans
6Bleach / H2O2 / Peracetic Acid Hierarchy of DisinfectantsIncreased Microbial Efficacy and/or Regulatory ClaimsEase of UseBleach / H2O2 / Peracetic Acid(Spor-Klenz)Phenolics (LpH, Vesphene)Peroxide and QuatsProcess NPD, Biocide A & BAlcohols
7Sanitizers vs. Disinfectants vs. Sterilants Chemical TypeFunctionalitySanitizers(Sterile Alcohol)Disinfectant Cleaners (Low or Intermediate level Germicides)Sterilants (High Level Germicides)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.
8Summary & Comparison Of Liquid Disinfectants Compiled by University of VirginiaClassRecommended UseHow They WorkAdvantagesDisadvantagesComments & HazardsExamples70% 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 expensiveHigh VOC’s 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- SteriholChlorine 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)
9Peroxide/ Peroxide & Peracetic Acid Summary & Comparison Of Liquid Disinfectants…cont.Compiled by University of VirginiaClassRecommended UseHow They WorkAdvantagesDisadvantagesComments & HazardsExamplesPeroxide/ Peroxide & Peracetic AcidGeneral Housekeeping Bactericidal - Very Good Fungicidal - Excellent Virucidal – ExcellentSpores- 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 waterGood safety and Environmental profile-Peroxide easily inactivated by organicresidues-Peroxide/Peracetic acid limited penetration of residue laden surfaces-Pre-cleaning a requirementPeracetic acid/hydrogen peroxide hard to use due to unstable solution-Klercide CR Biocide C -Spor-KlenzPhenolic CompoundsBactericidal - Excellent Fungicidal - Excellent Tuberculodial - Excellent Virucidal - Excellent@10 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, noHigh residues-Skin and eye irritant -Sensitizer -Corrosive -Toxic-Hil-Phene -Lph -Metar -VespheneQuaternary 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 End-Bac -Hi Tor-Klercide-CR Biocide A & B
10Sanitizing Agents/Sterile Alcohol StrengthsWeaknessesLow Residue SignatureQuick DryingGood Cleaning Performance if applied to wiperHard to apply evenly in sufficient volumeVery expensive (>when Sprayed to surface)High VOC’s (>when sprayed to surface)Poor removal of disinfectant residue
11Sterile Alcohol/In Use Reality SOP ObjectiveSOP Compliance IssueSanitize surfaces by removing residues and particles that harbor micro-organismsRinse surfaces of disinfectant residuesCurrent wipers make it difficult to wet the entire surface.Operator to operator non-uniformityTo achieve even minimal contact times surfaces are sprayed, then wipedBleach, Phenolic and Quat residues are not easily removed.
12Low Level Germicides (Quats)/ Biocide A & B, Coverage Plus StrengthsWeaknessesBactericidal and FungicidalSome Virucidal activityNon Corrosive and non irritating5-15 minute contact timesNot Sporicidal and No TBMedium Level of residuePoor cleaning action against biofilms
14Intermediate Level Germicides(H2O2/Biocide C) StrengthsWeaknessesFast acting Fungicidal, Virucidal & Bactericidal15 minutesNo residuesGood safety profileMust be used on a clean, residue free surfaceNo cleaning ability
15Germicides/Disinfectant Cleaners-The Real World SOP Compliance IssuesSOP ObjectiveMicrobial reductions rely on achieving label indicated contact times times which are very difficult to achieve with mopping or wiping in high air flow roomsRinse protocols are not easily metMopping & Wiping are very operator dependentAchieve 5 log reduction on clean room surfacesEffective use depends on removing residue buildup
16High Level Germicides Bleach/Spor-Klenz StrengthsWeaknessesBroad Level activity including SporesH202/Peracetic acid/ Spor-Klenz are fast acting (5 minute contact times for some organisms)Long contact times required for sporesBleach has high residue levels and is very corrosiveBleach is a poor cleaner and presents safety issuesH2O2/Paracetic acid is concentration dependent so hard to use
17High Level Germicides/Sterilants In use Reality SOP ObjectivesSOP Compliance IssuesEliminate spore contaminationResidue levels must be lowBleach, especially is dependent on long contact timesPre-cleaning and rinsing steps are hard to completeOften used more frequently than desirable
18Applying Disinfectants Via Spray Spray top to bottomBest wetting of the surface 7-10 minutes or longerPenetrates tight spots and rinses possibly existent contaminantsCleaning: power spray = not optimalDisinfection: light spray = excellentSpraying alone does not clean the surface and residues and particulate can build upElectrical issues need to be considered
19Applying Disinfectants Via Mopping Mop top to bottom with overlapping strokesMopping is a mechanical action on the surfaceThis loosens particulate and residues which removes some of the contaminatesWhile loosening and removing some, it does not remove allSurface wetting is minimal and less than two minutes of contact time is typical
20Applying Disinfectants Via Wipers Wipe in one direction back to front towards personCleaning a surface should be done with a damp wipe that soaks up a chemical agentCleaning is not done with a saturated wipe as contaminants cannot be lifted from the surfaceDisinfection with a saturated wipe requires the wipe to be wetted and surface to be air driedWipes need to be changed often
21Applying Disinfectants Via Fogging Many types of FoggersFog: 12 x 15 room – two foggers for at least two hoursFogging for startup reduces the bioburden in the areaFogging is an excellent way to regain control of a corrupted areaFogging needs to be done at a droplet size of 25 um (1-2 hours) or gap between droplets can occurFogging requires a release time (2-3 hours) and does not clean – should be followed with a cleaningMethod for wet fog
22Residues Can Be The Undefined Enemy Some SOP’s specify residue levels on surfaces but some specify that the surface is cleanSome residues do not show up on a white wiperSome SOP’s call residue removal rinsing
23Contact Time=Wet TimeCommon misconception is that contact time is total time on the surfaceQC and Management do not understand that operators often do not cover the entire surfaceActually, contact time is the time the surface is wetOperator technique variations can affect contact times
26Decontamination Red Flags Overuse of sporicidesMore frequently than validation indicatedVisible cues - If the room doesn’t look clean, it probably isn’tStained windowsStained tanksSticky floorsFrequency of passing alerts or action levels
27Auditing Cleaning Practices Contact Times How are you meeting disinfectant label contact time requirements?What are the contact times as specified by your SOP?Are your practices consistent with your SOP?Are contact times being logged?
28Auditing Cleaning Practices Residues How are you removing disinfectant residues from equipment?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?
29Typical Compliance Issues SOP IssueImproved SOP’sContact Times not being met or spraying required to meet contact timesHigh disinfectant residuesVery frequent sporicide rotationsCoverMAX/PharmaMOP offer disinfection and cleaning in one stepMiraWIPE and Microfiber mopsBetter cleaning and contact times may reduce the need to rotate in sporicides
30Summary Having a robust decontamination SOP is critical Improved disinfectant contact times are a major benefitHigh residue levels are typical and difficult to handleOne step cleaning and disinfection is a significant improvement over current practices