various aspects of viable monitoring in a gmp controlled...
TRANSCRIPT
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1 .. minute session
Cleaning & Disinfection
Peter Koger
Veltek Associates Inc.
www.sterile.com
With reference to Veltek
Associates Inc.
Biography
• Peter Koger has been active in the life science industry for over 30
years. First 12 years working in different laboratories in microbiology
and the remainder working for various international organizations,
active in the life science/pharmaceutical industry. For about 12 years
Peter has been a technical resource to the pharmaceutical industry
in relation to viable monitoring and cleaning&disinfection. Since
2002 he is a frequent industry speaker and since 2004 a faculty
member and trainer with the PDA in Europe Since 2005 Peter is
working with Veltek Associates Inc., a leading manufacturer of
sterile disinfectants, detergents, viable monitoring equipment and
several other innovative products focused on the Pharmaceutical
industry. His role is that of a Technical Sales Manager responsible
for Europe and Asia.
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
INNOVATION…
Innovation solicits creation.
Creation summons thought.
Thought relies on inspiration.
Inspiration promotes action.
Action invites movement.
Movement warrants relocation.
Relocation creates unfamiliarity.
Unfamiliarity forces learning.
Learning returns us to innovation.
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
1981
Founded by Art Vellutato, Sr.
Began production of disposable garments in a clean
room from beginning to end to assure the
cleanliness of the final product
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
1985
Designed the SMA™ the first microbial air sampler that could be
completely sterilized
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
1992
Developed DECON-AHOL® the first 0.2 micron
filtered alcohol that was irradiated in a non-
aspirating aerosol spray container
With reference to Veltek
Associates Inc.
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3
Overview of Veltek Associates, Inc.
1993
Began a complete line of sterile chemicals,
disinfectants and sporicides that are filtered at 0.2
microns
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
1996
Introduced the first 0.2 micron filtered and
sterilized clean room lubricants
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
SCMD - Sterile Chemical Manufacturing Division
DEC-AHOL WFI® STER-AHOL WFI ®
ALCOH-WIPE® ALCOH-GLOVE®
DEC-HAND® DEC-PHENE®
DEC-PHASE® DEC-CYCLE®
PHENE-AHOL® DEC-Clean®
DEC-QUAT 100® HYPO-CHLOR®
STERI-PEROX® DEC-SPORE 200 Plus®
STERI-WATER® VAI WFI Quality Water®
STERI-BUFFER® STERI-OIL 200®
STERI-SILICON® STEEL-BRIGHT®
DAS-WIPE® DEC-GLASS®
SimpleMIX® Process2Clean®
Cage2Wash® With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
1997
Designed and manufactured sterile ingredients for
use in parenteral manufacturing
Introduced the first computerized microbial air
sampling system
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
2003
Developed the Core2Clean.
A fully autoclavable system that allows for excellent
cleaning&disinfection in 50% of the time needed
with mop&bucket
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
2004
Developed the SimpleMIX® System - a
multi-chamber system designed to
eliminate filter sterilizing of disinfectants
and sporicides
Moved into a new state-of-the-art, 240,000
square foot, FDA and EPA registered facility
in Malvern, PA
With reference to Veltek
Associates Inc.
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5
Overview of Veltek Associates, Inc.
2007
Introduction of the new Process2Clean and
Cage2Wash product lines.
Developed to help improve and ease the
process of clean-in-place applications and
animal cage washing facilities.
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
2009
DDC – Digital Control Center with digital
flow control on each sample point
DRY-WIPES – sterile 12 x 12” dry wipes
SPORICIDAL-WIPE – saturated wipe
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
2010
Saturated disinfectant and sporicidal
wipes
2011
Saturated neutral detergtent Wipe
New hands free IPA or hand sanitizer
dispenser
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
2012
Sterile Aerosol WFI
2013
Aerosol Disinfectants
Easy2Write – Sterile Indistructable Paper
Easy2Print – Sterile Cleanroom Printer
With reference to Veltek
Associates Inc.
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Overview of Veltek Associates, Inc.
2013
With reference to Veltek
Associates Inc.
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SMA OneTouch® ICS
The capabilities of a single SMA
OneTouch ICS replaces ALL of our
previous generation of equipment
COMBINED.
Overview of Veltek Associates, Inc.
4 Divisions
SCMD - Sterile Chemical Manufacturing Division
ECMD - Environmental Control Monitoring Division
DPMD - Disposable Products Manufacturing Division
VLTD - VAI Labs Testing Division
1 Affiliate
API® - Aseptic Processing, Inc. a consulting firm for the
pharmaceutical and biotechnology industries
With reference to Veltek
Associates Inc.
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The total is more than the sum of
its parts……
• Process (formulation, filtration, filling, sealing)
• People (gowning, movements, limited access,
training)
• Facility (layout, design, pressurization, HEPA,
maintenance, temp., humidity, water/drain)
• Sanitization (cleaning/disinfecting agents,
environmental monitoring)
With reference to Veltek
Associates Inc.
Controlling What Enters
the Environment
With reference to Veltek
Associates Inc.
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Requirements for a cleaning and
disinfecting program • Written procedures describing in sufficient detail the
cleaning and disinfection procedures, schedules and materials used, preventing microbiological contamination
• Validation of the cleaning and disinfection agents
• EM data serves as a basis for the selection and evaluation of the agents
• Procedure should include rotation, sporocidal use and cleaning exercises to address possible residues.
• Disinfectants and cleaning agents in Grade A/B should be sterile.
With reference to Veltek
Associates Inc.
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Choosing the right
Disinfectants and Cleaners –
But what is the difference?
Cleaning is often confused
with Disinfection…..
They are NOT the same
With reference to Veltek
Associates Inc.
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Cleaning
the
Environment
With reference to Veltek
Associates Inc.
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Associates Inc.
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Cleaning versus Disinfection
• Cleaning
• Removal of
Particulate and
Microbes from the
surface
• Removal of
Residues and build-
up that can
complicate
Disinfection
• Disinfection
• Saturate and
Penetrate the cell
wall
• For “X” time period
• Concern with
particulate, resiudes
and irregular
surfaces With reference to Veltek
Associates Inc.
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Cleaning versus Disinfection
• Surfaces complicate cleaning and
disinfection
• Flat surfaces are easier to clean, but dry
faster
• Intricate surfaces are harder to clean and
dry slower
• The remaining residual after rinse is the
question With reference to Veltek
Associates Inc.
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Cleaning Walls, Ceilings, curtains
and Floors
• Scrub with a mop and solution which has excellent detergency
• Before the surface dries, rinse the surface with water
• Collect the remaining liquid on the floor and wet vacuum it out of the area
• Allow the surface to dry and then disinfect
With reference to Veltek
Associates Inc.
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Cleaning Filling Lines and Process
Equipment
• Scrub the surface with a wipe and a
solution which has excellent detergency
• Before the surface dries, rinse the surface
and wipe with a dry wipe, lifting the
solution
• Allow the surface to dry and then disinfect
With reference to Veltek
Associates Inc.
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Cleaning Carts, Tanks and Tools
• Scrub the surface with a wipe and a
solution which has excellent detergency
• Before the surface dries, rinse the surface
and wipe with a dry wipe, lifting the
solution
• Allow the surface to dry and then disinfect Carts and Tools should be removed, cleaned
and autoclaved if possible !! With reference to Veltek
Associates Inc.
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Why cleaning?
• Cleaning return the surface to its original
state, which is good starting point for
disinfection
• Cleaning addresses residues from earlier
disinfection
• Required by regulatory
With reference to Veltek
Associates Inc.
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Residues
Phenol
Sodium hypo chlorite
Quaternary ammonium With reference to Veltek
Associates Inc.
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The effect of
rinsing
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Associates Inc.
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Using water against residues
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Associates Inc.
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Using DecClean against residues
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Associates Inc.
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Choosing
Disinfectants/Sporocide • Type and number of microbes present
• Type of activity desired
• Type and amount of organic matter present
• Potential for corrosion or deterioration
With reference to Veltek
Associates Inc.
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• The choice is mostly delineated by review of the contamination you have noticed in your facility’s Environmental Isolate list, next to the required ATCC strains.
• The goal is broad spectrum disinfection
• Effect of certain disinfectants on final product (compatibility)
Choosing
Disinfectants/Sporocide
With reference to Veltek
Associates Inc.
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Chemical Gram + Gram - Spores Fungi Viruses
Isopropyl Alcohol 3 3 0 2 3
Ethanol 3 3 0 2 3
Quaternary Ammonium 3 1 0 2 3
Phenol High pH 3 2 1 3 3
Phenol Low pH 3 2 1 3 3
Hydrogen Peroxide (6%) 3 2 2 3 3
Bleach 4 4 4 4 4
Peracetic Acid & H2O2 4 4 4 4 4
Glutar Aldehyde 4 4 4 4 4
Disinfectant characteristics
With reference to Veltek
Associates Inc.
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Chemical Corrosive Staining Toxic
Isopropyl Alcohol NO NO NO
Ethanol NO NO NO
Quaternary Ammonium 1 NO NO
Phenol High pH 1 NO YES
Phenol Low pH 1 NO YES
Hydrogen Peroxide (6%) NO NO YES
Bleach 2 NO YES
Peracetic Acid & H2O2 2 1 YES
Glutar Aldehyde 2 1 YES
Disinfectant characteristics
With reference to Veltek
Associates Inc.
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Isopropyl versus Ethyl alcohol
• 90% of all drug companies use IPA
• 70% kills dried organisms better than higher percentage
• Ethanol and IPA show little differences in killing efficiency but seem more effective on clean room organisms
• Both have poor detergency
• Sterility and continued sterility over use is critical
With reference to Veltek
Associates Inc.
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Phenols • Often used in high pH/low pH rotation
• Good broad spectrum kill of vegetative organisms with some log reduction of spores
• Medium detergency
• Residues build up and darken with age from light
• High pH amber turns to dark brown, low pH is pink turns to dark purple
• Residue is difficult to remove and sets (IPA/cleaner)
With reference to Veltek
Associates Inc.
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Quats
• Good broad spectrum kill of vegetative
cells
• Excellent detergency, they remove
residues during the CLEANING operation
• Residues are minimal
With reference to Veltek
Associates Inc.
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Peroxides
• Good broad spectrum kill of vegetative cells
• Used in 3% and 6%
• Sometimes rotated with quats
• Some log reduction of spores
• No detergency
• Residues are non existent
With reference to Veltek
Associates Inc.
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Sodium Hypo Chlorites
• Used as a sporocide at 0.25% or greater
• Good broad spectrum kill of vegetative cells and spores
• Good detergency
• Excellent (long) dry time
• High residue which needs to be addressed, or corrosion will occur
• Oldest sporocide With reference to Veltek
Associates Inc.
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Peracetic acid + H2O2 • Used as a disinfectant (0.4%) or sporocide
(5%)
• Good broad spectrum kill of vegetative cells and spores
• No detergency
• Vapors are exponential of H2O2 and acetic acid
• Average dry time
• Residuals are minimal if any
• Dries porous surfaces over time
With reference to Veltek Associates Inc.
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Disinfectant performance • Temperature
• Saturation and Penetration of the Cell Wall
• Contact time
• Soil load and Bioburden
• Concentration
• pH
• Hardness of water
• Surface irregularity With reference to Veltek
Associates Inc.
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Rotation because of possible
resistance • USP <1072>
– “The development of microbial resistance to
antibiotics is a well-described phenomenon. The
development of microbial resistance to
disinfectants is less likely, as disinfectants are
more powerful biocidal agents and are applied in
high concentrations against low populations of
micro organisms, so the selective pressure for
the development of resistance is less profound”.
With reference to Veltek
Associates Inc.
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Nevertheless….
• Rotation is still required. Possibilities
are:
– Two disinfectants and a sporocide
– One disinfectant and a sporocide
– One agent at different concentrations
With reference to Veltek
Associates Inc.
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One Disinfectant and a Sporocide
Day(s) Phenolic Quad H2O2
1-13 Low pH phenol Quaternary
ammonium
Hydrogen
peroxide
14 (if warranted
by EM)
Clean, allow to
dry, use
sporocide
Clean, allow to
dry, use
sporocide
Clean, allow to
dry, use
sporocide
15-29 Low pH phenol Quaternary
ammonium
Hydrogen
peroxide
30 (if warranted
by EM)
Clean, allow to
dry, use
sporocide
Clean, allow to
dry, use
sporocide
Clean, allow to
dry, use
sporocide
After disinfection, when all surfaces are dry, all critical surfaces should be
rinsed with hot WFI or an IPA wipedown performed.
With reference to Veltek
Associates Inc.
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Time to validate our choices
“The firm has not supported the use
of current disinfecting agents with
data proving that such disinfectants
are effective in controlling
contamination noticed through their
environmental monitoring program”
With reference to Veltek
Associates Inc.
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Use and Application
• More than the availability of the right
detergents, disinfectants and sporocidal
agents, is the quality of the surfaces that
need be addressed and the way they are
being applied, determining the final
“cleanliness” of the classified area.
With reference to Veltek
Associates Inc.
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Scanning Electron
Microscopic views of surfaces
The surface to be disinfected
With reference to Veltek
Associates Inc.
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Associates Inc.
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General order of Disinfection
• Clean the area (line clearance)
• Disinfect Ceilings
• Disinfect Walls
• Disinfect Equipment
• Disinfect floors
• Allow to air dry
• Rinse or IPA wipe down of equipment
• Once a month Clean and Rinse all surfaces
With reference to Veltek
Associates Inc.
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Applying Disinfectants
• Mop
• Wipe
• Spray
• Fog
• STRUCTURED COMBINATION OF ALL
With reference to Veltek
Associates Inc.
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When to apply disinfectants Area type Ceilings Walls Floors Curtains Critical
work
surface
Class A/B Weekly Weekly
mopping
and poss.
Daily
spraying
Daily Daily Daily
Class C Weekly Weekly Daily Daily if
applicable
Daily
Class D Monthly Monthly Weekly NA Daily
With reference to Veltek
Associates Inc.
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Wrap up ……. • A proper cleaning and disinfecting SOP,
should be based on EM data and a lot of
common sense.
• Only if and when carried out correctly, with a
good selection of the parameters (choice of
chemicals and application methods) longer
term success is attainable
• CONTROL what ENTERS !!!
• Train, train, train, and when you are done
training……... You train some more. With reference to Veltek Associates Inc.
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Thank you for your interest.
With reference to Veltek
Associates Inc.