various aspects of viable monitoring in a gmp controlled...

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1 .. minute session

Cleaning & Disinfection

Peter Koger

Veltek Associates Inc.

[email protected]

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.


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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.


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mailto:[email protected]

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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


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1985

Designed the SMA™ the first microbial air sampler that could be

completely sterilized


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1992

Developed DECON-AHOL® the first 0.2 micron

filtered alcohol that was irradiated in a non-

aspirating aerosol spray container


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1993

Began a complete line of sterile chemicals,

disinfectants and sporicides that are filtered at 0.2

microns


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1996

Introduced the first 0.2 micron filtered and

sterilized clean room lubricants


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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

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1997

Designed and manufactured sterile ingredients for

use in parenteral manufacturing

Introduced the first computerized microbial air

sampling system


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2003

Developed the Core2Clean.

A fully autoclavable system that allows for excellent

cleaning&disinfection in 50% of the time needed

with mop&bucket


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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


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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.


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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


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2010

Saturated disinfectant and sporicidal

wipes

2011

Saturated neutral detergtent Wipe

New hands free IPA or hand sanitizer

dispenser


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2012

Sterile Aerosol WFI

2013

Aerosol Disinfectants

Easy2Write – Sterile Indistructable Paper

Easy2Print – Sterile Cleanroom Printer


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2013


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SMA OneTouch® ICS

The capabilities of a single SMA

OneTouch ICS replaces ALL of our

previous generation of equipment

COMBINED.


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


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http://www.sterile.com/store/sma-onetouch-control-panels/5-location-onetouch-control-panel-sma-ot-04-105-o4i_1124.aspx

http://www.sterile.com/store/sma-ddc/10-location-digital-display-control-center-405v-sma-ddc-10-405-o4i_1226.aspx

http://www.sterile.com/store/sma-in-line-flow-switches/5-port-power-supply-for-in-line-flow-switches-sma-ilfw-aux-5-o4i_1100.aspx

http://www.sterile.com/store/onetouch-control-panel-parts/cable-kit-for-sma-ot-04-105-50-sma-ot-04-105-ck-50-o4i_1129.aspx

http://www.sterile.com/store/in-line-flow-switch-parts/cable-tubing-kit-for-sma-ilfw-8-tier-50-sma-ilfw-8-tier-ck50-o4i_1096.aspx

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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)


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Controlling What Enters

the Environment


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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.


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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


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Cleaning

the

Environment


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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

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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

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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


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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


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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

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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


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Residues

Phenol

Sodium hypo chlorite

Quaternary ammonium With reference to Veltek

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The effect of

rinsing


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Using water against residues


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Using DecClean against residues


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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


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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


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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


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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


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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


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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)


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Quats

• Good broad spectrum kill of vegetative

cells

• Excellent detergency, they remove

residues during the CLEANING operation

• Residues are minimal


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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


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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

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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

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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

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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”.


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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


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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.


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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”


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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.


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Scanning Electron

Microscopic views of surfaces

The surface to be disinfected


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52 With reference to Veltek

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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


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Applying Disinfectants

• Mop

• Wipe

• Spray

• Fog

• STRUCTURED COMBINATION OF ALL


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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


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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.


Associates Inc.

various aspects of viable monitoring in a gmp controlled...

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