Understanding Decontamination SOP’s

1. Understanding Decontamination SOP’s Cleaning + Disinfection = Decontamination

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

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

4. General Order Of Disinfection • Disinfect ceilings and walls • Clean the area (line clearance) • Disinfect equipment (if applicable) • Rinse or IPA wipe down of equipment • Disinfect floors • Allow to air dry • 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 • 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

6. Hierarchy of Disinfectants Increased Microbial Efficacy and/or Regulatory Claims Ease of Use

7. Sanitizers vs. Disinfectants vs. Sterilants Chemical Type 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. • Sanitizers(Sterile Alcohol) • Disinfectant Cleaners (Low or Intermediate level Germicides) • Sterilants (High Level Germicides)

8. Summary & Comparison Of Liquid Disinfectants Compiled by University of Virginia

9. Summary & Comparison Of Liquid Disinfectants…cont. Compiled by University of Virginia

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

11. Sterile Alcohol/In Use Reality SOP Objective 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. • Sanitize surfaces by removing residues and particles that harbor micro-organisms • Rinse surfaces of disinfectant residues

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

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

14. Intermediate Level Germicides(H2O2/Biocide C) Strengths Weaknesses Must be used on a clean, residue free surface No cleaning ability • Fast acting Fungicidal, Virucidal & Bactericidal • Sporicidal @ 15 minutes • No residues • Good safety profile

15. Germicides/Disinfectant Cleaners-The Real World SOP Objective 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 • Achieve 5 log reduction on clean room surfaces • Effective use depends on removing residue buildup

16. High Level Germicides Bleach/Spor-Klenz Strengths 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 H2O2/Paracetic acid is concentration dependent so hard to use • Broad Level activity including Spores • H202/Peracetic acid/ Spor-Klenz are fast acting (5 minute contact times for some organisms)

17. High Level Germicides/Sterilants In use Reality SOP Objectives 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 • Eliminate spore contamination • Residue levels must be low

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

19. Applying Disinfectants Via Mopping • Mop top to bottom with overlapping strokes • Mopping is a mechanical action on the surface • This loosens particulate and residues which removes some of the contaminates • While loosening and removing some, it does not remove all • 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 • 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 • Disinfection with a saturated wipe requires the wipe to be wetted and surface to be air dried • Wipes need to be changed often

21. Applying Disinfectants Via Fogging • Many types of Foggers • Fog: 12 x 15 room – two foggers for at least two hours • Fogging for startup reduces the bioburden in the 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 requires a release time (2-3 hours) and does not clean – should be followed with a cleaning Method for wet fog

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

23. Contact Time=Wet Time • 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 • Actually, contact time is the time the surface is wet • Operator technique variations can affect contact times

24. Typical Product Claims Sporicidal Agent • Sterilant/Sporicidal [B. subtilis (ATCC 19659), C. sporogenes (ATCC 3584)] Bactericidal, Fungicidal, Virucidal . . . . . . . . . . . . . . . . . . . . . . . . . undiluted 5-1/2 hours 20oC • Sporicidal – Non-porous Surfaces [B. subtilis (ATCC 19659), C. sporogenes (ATCC 3584)] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . undiluted 30 minutes 20oC • Broad Spectrum Disinfectant [S. aureus (ATCC 6538). S. enterica (ATCC 10708)]. . . . . . . . . . undiluted 30 minutes 20oC 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 20oC • Germicidal Spray Disinfectant [S. aureus (ATCC 6538), S. enterica (ATCC 10708)] . . . . . . . . . . . . . . . . . . . . . . undiluted 5 minutes 20oC • Non-food Contact Surface Sanitizer [S. aureus (ATCC 6538), K. pneumonicae (ATCC 4352)] . . . . . . . dilute 50X (1 part to 49 part water) for 5 minutes 21oC

26. Decontamination Red Flags • Overuse of sporicides • More frequently than validation indicated • Visible cues - If the room doesn’t look clean, it probably isn’t • Stained windows • Stained tanks • Sticky floors • Frequency of passing alerts or action levels

27. Auditing Cleaning PracticesContact 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?

28. Auditing 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?

29. Typical Compliance Issues SOP Issue Improved SOP’s 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 • Contact Times not being met or spraying required to meet contact times • High disinfectant residues • Very frequent sporicide rotations

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