understanding decontamination sops cleaning + disinfection = decontamination

Understanding Decontamination SOP’s

Cleaning + Disinfection = Decontamination

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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


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


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


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


Bleach / H2O2 / Peracetic Acid(Spor-Klenz)

Phenolics (LpH, Vesphene)

Peroxide and QuatsProcess NPD, Biocide A & B

Alcohols

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Hierarchy of Disinfectants


Sanitizers vs. Disinfectants vs. Sterilants

Chemical Type Sanitizers(Sterile

Alcohol)

Disinfectant Cleaners (Low or Intermediate 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.


Class RecommendedUse

HowTheyWork

Advantages Disadvantages Comments

&Hazards

Examples

70% IsopropylAlcohol

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

- Sterihol

ChlorineCompounds

-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


Class RecommendedUse

HowTheyWork

Advantages Disadvantages Comments

&Hazards

Examples

Peroxide/ Peroxide &

Peracetic Acid

General 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 water Good safety and Environmental profile

-Peroxide easily inactivated by organicresidues-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

PhenolicCompounds

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

QuaternaryAmmoniumcompounds

(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


Sanitizing Agents/Sterile Alcohol

Strengths Low Residue Signature

Quick Drying

Good Cleaning Performance if applied to wiper

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


Sterile Alcohol/In Use Reality

SOP Objective Sanitize surfaces by

removing residues and particles that harbor micro-organisms

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.


Low Level Germicides (Quats)/ Biocide A & B, Coverage Plus

Strengths

Bactericidal and Fungicidal

Some Virucidal activity

Non Corrosive and non irritating

5-15 minute contact times

Weaknesses Not Sporicidal and No

TB

Medium Level of residue

Poor cleaning action against biofilms


Intermediate Level Germicides (Phenolics/Vesphene, LpH )

Strengths Broad level activity-

Virucidal, Bactericidal, Fungicidal &Tuberculoid

Maintains activity on soiled surfaces

Good cleaning action on soiled surfaces

Weaknesses No Spores

High residue levels

Minimum 10 minute contact time

Operator Safety Issues


Intermediate Level Germicides(H2O2/Biocide C)

Strengths Fast acting Fungicidal,

Virucidal & Bactericidal

Sporicidal @ 15 minutes

No residues

Good safety profile

Weaknesses Must be used on a

clean, residue free surface

No cleaning ability


Germicides/Disinfectant Cleaners-The Real World

SOP Objective

Achieve 5 log reduction on clean room surfaces

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


High Level Germicides Bleach/Spor-Klenz

Strengths Broad Level activity

including Spores H202/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

H2O2/Paracetic acid is concentration dependent so hard to use


High Level Germicides/Sterilants

In use RealitySOP Objectives Eliminate spore

contamination

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


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


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


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


Applying Disinfectants Via Fogging

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

Many types of Foggers

Method for wet fog


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


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


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 20oCTuberculocidal (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)


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


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


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?


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?


Typical Compliance Issues

SOP Issue Contact Times not

being met or spraying required to meet contact times

High disinfectant residues

Very frequent sporicide rotations

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


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

understanding decontamination sops cleaning + disinfection = decontamination

Documents

surfaces slide

clean surfaces

high level sterilants

complete cleaning

decontamination slide

surface sop compliance

intimate contact

high residues