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

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

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. Bleach / H2O2 / Peracetic Acid
Hierarchy of Disinfectants
Increased Microbial Efficacy and/or Regulatory Claims
Ease of Use
Bleach / H2O2 / Peracetic Acid
(Spor-Klenz)
Phenolics (LpH, Vesphene)
Peroxide and Quats
Process NPD, Biocide A & B
Alcohols

7. Sanitizers vs. Disinfectants vs. Sterilants
Chemical Type
Functionality
Sanitizers(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.

8. Summary & Comparison Of Liquid Disinfectants
Compiled by University of Virginia
Class
Recommended Use
How They Work
Advantages
Disadvantages
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 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
- 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)

9. Peroxide/ Peroxide & Peracetic Acid
Summary & Comparison Of Liquid Disinfectants…cont.
Compiled by University of Virginia
Class
Recommended Use
How They Work
Advantages
Disadvantages
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 - 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, 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 End-Bac -Hi Tor
-Klercide-CR Biocide A & B

10. Sanitizing Agents/Sterile Alcohol
Strengths
Weaknesses
Low Residue Signature
Quick Drying
Good Cleaning Performance if applied to wiper
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

11. Sterile Alcohol/In Use Reality
SOP Objective
SOP Compliance Issue
Sanitize surfaces by removing residues and particles that harbor micro-organisms
Rinse surfaces of disinfectant residues
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
Weaknesses
Bactericidal and Fungicidal
Some Virucidal activity
Non Corrosive and non irritating
5-15 minute contact times
Not Sporicidal and No TB
Medium Level of residue
Poor cleaning action against biofilms

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

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

15. Germicides/Disinfectant Cleaners-The Real World
SOP Compliance Issues
SOP Objective
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
Broad Level activity including Spores
H202/Peracetic acid/ Spor-Klenz are fast acting (5 minute contact times for some organisms)
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

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

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
Contact Times not being met or spraying required to meet contact times
High disinfectant residues
Very frequent sporicide rotations
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
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