PPT - Foamtec

Report
Understanding
Decontamination SOP’s
Cleaning + Disinfection =
Decontamination
Overview
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SOP’s
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Compliance
Order of
Disinfection
Typical SOP’s
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Disinfectants
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Types and
properties
Strengths &
weaknesses
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Wipers
Mops
Fogs
Residue
Contact times
Compliance
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Application
techniques
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
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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
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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
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Bleach / H2O2 / Peracetic Acid
(Spor-Klenz)
Phenolics (LpH, Vesphene)
Peroxide and Quats
Process NPD, Biocide A & B
Alcohols
Ease of Use
Increased Microbial Efficacy and/or
Regulatory Claims
Hierarchy of Disinfectants
Sanitizers
vs.
Disinfectants
Chemical Type
 Sanitizers(Sterile Alcohol)
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Disinfectant Cleaners
(Low or Intermediate
level Germicides)
Sterilants (High Level
Germicides)
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vs.
Sterilants
Functionality

Offers 2 log reduction, no
impact on spores and no
residue.
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Offers 5 log reduction on a
soiled surface with
moderate residues.
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5 log reduction and spore
control on clean surfaces.
High residues.
Summary & Comparison Of Liquid
Disinfectants
Compiled by University of Virginia
Class
Recommended
Use
70% Isopropyl -Cleaning some
Alcohol
instruments
solution
-Cleaning skin
-General purpose
sanitizer for clean
room equipment
and work surfaces
Chlorine
Compounds
How
They
Work
-Changes protein
structure of
microorganism
-Presence of water
assists with killing
action
Advantages
Comments
&
Hazards
-Flammable
-Eye Irritant
-Toxic
-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
-Spills of human
-Free available
-Kills hardy viruses
-Corrodes metals such -Follow spill
body fluids
chlorine combines
(e.g. hepatitis)
as stainless, aluminum procedure and
with contents within -Kills a wide range of -Organics may reduce dilution instructions
microorganism,
organisms
activity
-Make fresh
Bactericidal - Good reaction byproducts
-Inexpensive
-Increase in alkalinity solutions before use
Fungicidal - Good cause its death
-Penetrates well
decreases bactericidal -Eye, skin and
Sporicidal - Good at -Need 500 to 5000
-Relatively quick
property
respiratory irritant
>1000ppm Sodium ppm
microbial kill
-Unpleasant taste and -Corrosive
Hypochlorite
-Produce chemical
-May be used on food odor
-Toxic
combination with cell prep surfaces
-Tuberculocidal,
substances
with extended contact
-Depends upon
time
release of
-heavy residues
hypochlorous acid
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-Very low in residue
Disadvantages
Examples
- Sterihol
-Bleach solutions
(sodium
hypochlorite)
-Clorox
-Cyosan
-Purex
-NaDCC (sodium
dichloroisocyanurate)
Summary & Comparison Of Liquid
Disinfectants…cont.
Compiled by University of Virginia
Class
Peroxide/
Peroxide &
Peracetic Acid
Phenolic
Compounds
Quaternary
Ammonium
compounds
(QUATS)
Recommended
Use
General
Housekeeping
Bactericidal - Very
Good
Fungicidal Excellent
Virucidal –
Excellent
Spores- good with
extended contact
times -30 minutes
Bactericidal Excellent
Fungicidal Excellent
Tuberculodial Excellent
Virucidal - Excellent
@10 minute
contact times
How
They
Work
-disrupts cell walls
Comments
&
Hazards
-Kills broad range of -Peroxide easily
-Pre-cleaning a
organisms
inactivated by organic requirement
-Low residues
residues
-5 minute contact
-Peroxide/Peracetic
Peracetic
time for Broad
acid limited
acid/hydrogen
Spectrum
penetration of residue peroxide hard to use
-Not affected by
laden surfaces
due to unstable
hard water
solution
Good safety and
Environmental profile
-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
Advantages
Disadvantages
-Unpleasant odor
-Skin and eye irritant
-Some areas have
-Sensitizer
disposal restrictions
-Corrosive
-Effectiveness reduced -Toxic
by alkaline pH, natural
soap or organic
material
-Sporicidal,
no
High residues
-Ordinary
-Affects proteins and -Contains a
-spores not eliminated -Select from EPA list
housekeeping (e.g. cell membrane of
detergent to help
by all brands, TB
of hospital
floors, furniture,
microorganism
loosen soil
bacteria, some viruses disinfectants
walls)
-Releases nitrogen
-Rapid action, 5
-Effectiveness
-Skin and eye irritant
and phosphorous from minute contact times influenced by hard
-Toxic
Bactericidal cells
-Colorless, odorless water
-Biocide B has good
Excellent
-Non-toxic, less
-Layer of soap
spore activity w/15
Fungicidal - Good
corrosive
interferes with action minute contact times
Virucidal - Good
-Highly stable
-high in residues
(not as effective as
-May be used on
phenols)
food prep surfaces
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Examples
-Klercide CR
Biocide C
-Spor-Klenz
-Hil-Phene
-Lph
-Metar
-Vesphene
-Coverage 258
-End-Bac
-Hi Tor
-Klercide-CR
Biocide A & B
Sanitizing Agents/Sterile Alcohol
Strengths
 Low Residue Signature
Weaknesses
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Quick Drying
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Good Cleaning
Performance if applied to
wiper
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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
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SOP Compliance Issue
 Current wipers make it
difficult to wet the entire
surface.
 Operator to operator nonuniformity
 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
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Weaknesses
 Not Sporicidal and No TB
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Medium Level of residue
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Poor cleaning action
against biofilms
Intermediate Level Germicides
(Phenolics/Vesphene, LpH )
Strengths
 Broad level activityVirucidal, Bactericidal,
Fungicidal &Tuberculoid
Weaknesses
 No Spores
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High residue levels
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Maintains activity on
soiled surfaces
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Minimum 10 minute
contact time
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Good cleaning action on
soiled surfaces
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Operator Safety Issues
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Intermediate Level
Germicides(H2O2/Biocide C)
Strengths
 Fast acting Fungicidal,
Virucidal & Bactericidal
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Sporicidal @ 15 minutes
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No residues
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Good safety profile
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Weaknesses
 Must be used on a clean,
residue free surface
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No cleaning ability
Germicides/Disinfectant CleanersThe Real World
SOP Objective
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Achieve 5 log reduction
on clean room surfaces
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Effective use depends on
removing residue buildup
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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)
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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 Reality
SOP Objectives
 Eliminate spore
contamination
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Residue levels must be
low
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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
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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
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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
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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
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Applying Disinfectants Via
Fogging
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Method for
wet fog
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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
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
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Contact Time=Wet Time
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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
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Actually, contact time
is the time the surface
is wet
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Operator technique
variations can affect
contact times
Typical Product Claims
Sporicidal Agent
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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)
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Product Claims . . . Cont.
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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
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Decontamination Red Flags
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Overuse of sporicides
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More frequently than validation indicated
Visible cues - If the room doesn’t look
clean, it probably isn’t
Stained windows
 Stained tanks
 Sticky floors
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Frequency of passing alerts or action
levels
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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?
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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?
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Typical Compliance Issues
SOP Issue
 Contact Times not being
met or spraying required
to meet contact times
Improved SOP’s
 CoverMAX/PharmaMOP
offer disinfection and
cleaning in one step
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High disinfectant residues
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Very frequent sporicide
rotations
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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
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