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Article CommentaryCommentary

Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program

Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler and Christopher Phillion
PDA Journal of Pharmaceutical Science and Technology March 2020, 74 (2) 249-263; DOI: https://doi.org/10.5731/pdajpst.2018.009662
Derek Willison-Parry
1BioPhorum, London, UK;
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  • For correspondence: derek@biophorum.com
Stephen Yang
2Merck & Co., Inc, Kenilworth, NJ;
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Ren-Yo Forng
3Amgen, Thousand Oaks, CA;
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Tim Cirbo
4Eli Lilly, Indianapolis, IN;
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Aileen Mcmeel
5Pfizer, New York, NY;
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Brian Kiler
6Roche, Basel, Switzerland; and
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Christopher Phillion
7Takeda, Cambridge, MA
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    Figure 1

    PDCA cycle for a successful disinfection program

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    TABLE I

    General Classification of Antiseptics, Disinfectants, and Sporicidal Agentsa

    Chemical EntityClassificationExample
    AldehydesSporicidal agent2% Glutaraldehyde
    AlcoholsGeneral purpose disinfectant, antiseptic, antiviral agent70% Isopropyl alcohol, 70% alcohol
    Chlorine and sodium hypochloriteSporicidal agent0.5% Sodium hypochlorite
    PhenolicsGeneral purpose disinfectant500 µg per gram Chlorocresol, 500 µg per gram chloroxylenol
    OzoneSporicidal agent8% gas by weight
    Hydrogen peroxideVapor phase sterilant, liquid sporicidal agent, antiseptic4 µg per gram H2O2 vapor, 10%–25% solution, 3% solution
    Peracetic acidLiquid sterilant, vapor phase sterilant0.2% Peracetic acid, 1 µg per gram peracetic acid
    Quaternary ammonium compoundsGeneral purpose disinfectant, antisepticConcentration dependent on application, Benzalkonium chloride
    • ↵a Table adapted from Reference 3.

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    TABLE II

    General Disinfectants (Bacteria, Yeasts, and Molds)a

    Microbicidal ActivityMode of Action
    Alcohols (e.g., isopropyl and ethanol): Broad-spectrum antimicrobial against vegetative bacteria, mycobacteria, viruses and fungiAlcohols owe their antimicrobial activity to their ability to denature cell proteins leading to a disruption of cellular function, and to a minor extent to their ability to cause membrane damage
    Alkaline: Bactericidal and virucidalHydrolyzes and removes proteins, nucleic acids, endotoxins, and viruses
    Acidic: Broad spectrum of bacteriaAttack lipid-rich cell walls
    • ↵a Information sourced from Reference 19.

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    TABLE III

    Sporicides (Spore-Forming Bacteria)a

    Microbicidal ActivityMode of Action
    Accelerated Hydrogen Peroxide Technology: Bactericidal, virucidal, fungicidal, broad-spectrum sanitizingHydrogen Peroxide: Produces destructive hydroxyl free radicals that attack membrane lipids, DNA and other essential cell components
    Peracetic acid, hydrogen peroxide, and acetic acid: Range of bacteria, molds, yeast and viruses (Registered uses: disinfectant, sterilant, sporicide, sanitizer, microbicide, virucide, fungicide, sporicidal disinfectant, antimicrobial solution, mold killing, one-step cleaner and disinfectant)Hydrogen Peroxide: Produces destructive hydroxyl free radicals that attack membrane lipids, DNA and other essential cell components
    Peracetic Acid: Denatures proteins, disrupts cell wall permeability
    • ↵a Information from Reference 20.

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    TABLE IV

    Hierarchy of Microbial Resistance to Disinfectants

    Resistance to Disinfectantsa
    More ResistantMicroorganismExamplesMore Resistant
    Embedded ImageBacterial SporesBacillus cereus/Bacillus sphaericusEmbedded Image
    Bacillus subtilis
    Clostridium spp.
    Mold SporesAspergillus, Penicillium
    Gram-negative bacteriaPseudomonas, Providencia, Escherichia
    Vegetative Mold and YeastAspergillus, Trichophyton, Candida
    Less ResistantGram-positive bacteriaStaphylococcus, Streptococcus, EnterococcusLess Resistant
    • ↵a Adapted from Reference 19.

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    TABLE V

    Risk Assessment Scoring for Challenge Surface Selection

    Risk LevelDescriptionScore
    HighSurface characteristics: The surface has high surface roughness, susceptibility to surface degradation and/or water absorption, and presence of surface soil.3
    Prevalence: The surface covers an important proportion of the facility surfaces and/or is often represented in different production areas (e.g., bulk or finishing).
    Operator interventions: During the process interventions, operators are in regular contact with the surface.
    MediumSurface characteristics: The surface properties do not facilitate microorganism development (low surface roughness, low level of degradation, low or no surface soil, etc.).2
    Prevalence: The surface covers a moderate proportion of the facility surfaces or is limited to a specific area (e.g., bulk or finishing).
    Operator interventions: During the process interventions, operators are infrequently in contact with the surface.
    LowSurface characteristics: The surface properties prevent any microorganism development (bacteriostatic or bactericidal properties, very low roughness, very resistant and inert, typically clean surface prior to disinfection, etc.).1
    Prevalence: The surface covers a small surface and/or is represented in only a few production rooms.
    Operator interventions: No process interventions with the surface.
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    TABLE VI

    Overall risk score = (Surface characteristics score) × (Prevalence) × (Operator interventions)

    Risk Priority NumberRisk Level
    <6Low Risk
    ≥6High Risk
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    TABLE VII

    Typical Disinfectant Efficacy Challenge Organisms

    Typical Disinfectant Efficacy Challenge Organismsa
    Intended UseAOAC Challenge OrganismsTypical Environmental Isolates
    BactericideE. coli: ATCC 11229M. luteus
    S. aureus: ATCC 6538S. epidermidis
    P. aeruginosa: ATCC 15442Corynebacterium jeikeium
    P. vesicularis
    FungicideC. albicans: ATCC 10231 or 2091P. chrysogenum
    Penicillium chrysogenum: ATCC 11709A. brasiliensis
    A. brasiliensis: ATCC 16404
    SporicideB. subtilis: ATCC 19659B. sphaericus
    B. thuringiensis
    • ↵a Adapted from Reference 3.

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PDA Journal of Pharmaceutical Science and Technology: 74 (2)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 2
March/April 2020
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Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler, Christopher Phillion
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 249-263; DOI: 10.5731/pdajpst.2018.009662

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Disinfectant Efficacy: Understanding the Expectations and How to Design Effective Studies That Include Leveraging Multi-Site Data to Drive an Efficient Program
Derek Willison-Parry, Stephen Yang, Ren-Yo Forng, Tim Cirbo, Aileen Mcmeel, Brian Kiler, Christopher Phillion
PDA Journal of Pharmaceutical Science and Technology Mar 2020, 74 (2) 249-263; DOI: 10.5731/pdajpst.2018.009662
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  • Article
    • Abstract
    • 1. Introduction
    • 2. Categories of Disinfectants and How They Differ
    • 3. Regulatory expectations with Regard to Disinfectant Efficacy Testing
    • 4. The Value of Environmental Monitoring Trending to Disinfectant Efficacy Testing
    • 5. Challenge Organism Selection for Disinfectant Efficacy Testing
    • 6. Challenge Surface Selection
    • 7. Leveraging Disinfectant Efficacy Data for Multiple Facilities
    • 8. Critical Parameters and the Holistic Management of a Disinfectant Efficacy Study Validation Program
    • 9. How to Bring a New Material into the Program
    • 10. Conclusion
    • Conflict of Interest Declaration
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