Enzymes for surgical
cleaners
4/13/2015
2009-08013-01
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NOVOZYMES PRESENTATION
CONTENT
Surgical cleaners
Enzymatic detergents
Biofilm
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Challenges for surgical cleaners
"...in the absence of careful
physical cleaning, most
disinfection and sterilization
processes are likely to be
ineffective. …only steam
autoclaving can overcome the
barrier effects of residual
organic matter."
Source: Gastrointestinal
Endoscopy Vol 50 no. 2 1999,
pg 288
 Removal of body tissue
soils like blood, mucous,
fats, and others
 Reduction of biofilms
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Formulation types of surgical cleaners
 Neutral pH Detergent
(pH 6 – 8)
 Alkaline pH Detergent
(pH 10-12)
 Enzymatic Detergent
(~Neutral, pH 7-8)
 Single enzyme (e.g.,
protease or lipase)
 Multi-enzyme
(protease, lipase,
amylase, cellulase…)
.
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Intended use of surgical cleaners
•
High or low
impingement washers
•
Manual applications
•
Ultrasonic
•
Presoak
•
Stain Removal
.
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Example of process – endoscope cleaning
 Effective cleaning of endoscopes is essential
 Endoscopes have fragile parts and should not be exposed
to high temperatures (>60°C) and autoclaving
 Flexible endoscope must be decontaminated by cleaning at
low temperatures and disinfected by cold chemicals
 Cleaning of flexible endoscopes is classified as a semicritical instrument since it penetrates skin and tissue.
 Must be disinfected with a high level disinfector (HLD)
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Types of surgical instruments and their use
Flexible endoscopes
Rigid endoscopes
Laparoscopes
Heat labile – can not be
autoclaved
Abdominal; minimum
invasive surgery
Gastro-Intestinal
inspections 10 million
inspections/year in US
(1995)
4.4 million inspections/
year in US
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2015
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NOVOZYMES PRESENTATION
The optimal process of endoscope cleaning (WGO)
Use of device
Rinsing with water
and manual
cleaning with
detergent
Automatic cleaning
with detergent
Disinfection
Rinsing with
bacteria-free water
or alcohol
Drying
Storage
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2015
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NOVOZYMES PRESENTATION
The optimal process of endoscope cleaning (WGO)
Room 1
Room 2
Room 3
Room 4
- The Operating
room
- The dirty room
- The reprocessing
room
- The storage room
Step 1
Step 2
Step 3-6
Use of the
Device
Rinsing with
water
Step 7
Washing,
disinfection,
rinsing with
bacteria-free
water or
alcohol &
drying
Storage
And manual
cleaning
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NOVOZYMES PRESENTATION
Washing with detergents
 This is the part of the cleaning
process where enzymes are
applicable
 This part of the reprocessing
process is very important, since
inadequate cleaning and
removal of biofilm inhibits
disinfection as defined by AAMI
 There are two methods of
washing/cleaning: manual and
automatic
Disinfection is defined as:
“The process of removing as much of
the contamination as possible, but not
necessarily killing the
microorganism.”
Source: TIR 30 – A Compendium of
cleaning of medical devices” by AAMI
(2003) (TIR 30)
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NOVOZYMES PRESENTATION
Enzymatic detergents

Enzymatic detergents are recommended in both Europe (ESGE), in the US (Multi-society
guidelines) and globally (WGO)

Can be positioned as a environmental friendly and more safe to handle substitute to more
harsh detergents

They are often the detergent of choice since they are effective at dissolving proteins and
operate at low temperatures in a neutral environment

The majority of the guidelines recommend that the health care facility uses the detergent
recommended by the manufacturer of the AER

The majority of the enzymatic detergents are multi-purposed and can be used in almost all
the automatic cleaners and as a manual cleaner

The manufacturers of the detergents use the enzymes as a selling point in their brochures
using between one to four different enzymes in their detergents (protease, lipase, amylase,
and cellulase)
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Complete blood removal with proteases
Time taken in min. to clean
Test stopped
GET FASTER BLOOD
REMOVAL WITH
ENZYMATIC
DETERGENTS
BLOOD IS THE MAIN AND MOST CRITICAL CONTAMINANT OF SURGICAL
INSTRUMENTS AND IT IS USED IN THE INTERNATIONAL STANDARD ISO15883 AS
CHOSEN TEST SOIL (TOSI TEST) TO CHECK THE EFFICACY OF CLEANING
PROCEDURES FOR SURGICAL INSTRUMENTATION REPROCESSING
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Reasons for cleaning
BLOOD FIXATION BY
STERILIZING AGENTS
(GLUTARALDEHYDE,
PERACETIC ACID)
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Endoscope cleaners in Brazil contain three to
four enzymes
Endoscope cleaners launched in
Brazil containing only one enzyme
Endoscope cleaners launched in Brazil
containing more than one enzyme
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NOVOZYMES PRESENTATION
Examples of enzymatic cleaners
.
Asepti-zyme from Ecolab is marketed as a
multi-purpose detergent that can be used for
manual decontamination, scope
washer/disinfectors, ultrasonics, washers and
sterilizers, and washer decontaminators, and
as a detergent that delivers:
•
•
•
•
Rapid action
Dissolves proteinacious matter
Super-concentrated
Low foaming - saves time
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NOVOZYMES PRESENTATION
Examples of enzymatic cleaners
Kimberly Clark’s multi–enzyme detergent for manual
Cleaning is marketed as:
• Effective; rapidly removes all types of soils (fats,
carbohydrate and protein)
• Compatible; can be used with a wide range of devices
• Low-Foaming; appropriate for manual and small
washer use
• Easy-To-Use; pump dispenses consistent 1 ounce dose
• User-Friendly; pleasant fragrance in an ergonomically
 designed package
• Process-Friendly; easily integrates into your current
practices
• Environment-Friendly; biodegradable and phosphatefree
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NOVOZYMES PRESENTATION
Examples of enzymatic cleaners
Korsolex Endo-cleaner from Bode is
marketed as:
• Excellent solving capacity for oil, dirt, blood and biofilm
• High degree of material compatibility for machine and
endoscope
• Little foaming
• Economical
• Phosphate-free
• Environmentally friendly
• Compatible with Korsolex® Endo-Disinfectant
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NOVOZYMES PRESENTATION
Examples of enzymatic cleaners
PRO EZ 2 from Certol is marketed as:

Dual enzymatic action dissolves both protein and starch
containing soils.

Superior surfactants remove loosened soils and emulsify
fats






Use as a presoak
Multipurpose: used in manual, ultrasonic, or automated
systems
Reduces unpleasant odors
Gentle, neutral pH and non-corrosive
The dispensing pump takes the guess work out of
measuring
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NOVOZYMES PRESENTATION
Novozymes’ positioning in I&I surgical
cleaner market
Segment
Novozymes
preferred
products
Selling points
Competitor
product
NZ product
discriminator
Enables improved
cleaning at low
temperatures
Alcalase /
Esperase/
Surgical
instrument
reprocessing
Alcalase Ultra
Stainzyme
Lipex
Viscozyme
Attacks all food
residue and body
soils efficiently
Mainly competing
Better overall
with
Peroxyacetic
Extended
performance,
acid and
equipment lifetime
milder conditions
surfactants and
Less hazardous
Less toxic
glutaraldehyde
chemicals to
chemicals
based detergents
handle
Cleaning and
hygiene in 1 step
Ultra to offset
MPG costs
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NOVOZYMES PRESENTATION
The problem with biofilms
Biofilms are ubiquitous in nature and cause
a variety of problems including:

Fouling of membranes

Biological fouling in medical instruments, oil
field injection wells, and cooling towers

Infections and disease in people (e.g.,
contamination of drinking water and dental
unit water)

Oral care/plaque buildup

Corrosion of metal surfaces by sulfurreducing bacteria (SRB’s)
Companies are attempting to address most
of these areas using detergent-type
Cleaners.
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Typical enzyme dosages
For initial formulation trials, in an endoscope cleaner used at a
5% concentration in the cleaning bath, the recommended
dosage levels of liquid enzymes are:
Enzyme
Category
Typical enzyme dosage in the
detergent, wt%
Proteases
10% (Savinase 16 L, Everlase 16 L, Alcalase
2.5 L,
Esperase 8.0 L, Liquanase 2.5 L)
Amylases
8% (Termamyl 300 L, Duramyl 300 L)
6% (Stainzyme 12 L, Stainzyme Plus 12 L)
Lipases
5% (Lipex 100 L, Lipolase 100 L)
Cellulases
5 % (Novozym 342, Celluzyme, Viscozyme)
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Polysaccharides produced by bacteria in biofilms
EPS Polymer
Linkage
Bacteria
Alginates
b-1,4 mannuronic acid
Pseudomonas
a-1,4 guluronic acid
Amylopectin
a-1,4 & a-1,6 glucose
Ecoli
Celluloses
b-1,4 glucose
Acetobacter
Colanic Acids
Glucose, galactose, fucose,
glucuronic acid, pyruvic acid
Salmonella, Ecoli
Dextrans
a-1,6 & a-1,4 glucose
Streptococcus, Acetobacter
Glycogen
a-1,4 & a-1,6 glucose
Bacillus, Pneumococci
Levans
b-2,6 fructose
Pseudomonas, Bacillus,
Aerobacter
Polymannans
b-1,4 mannose
Desulfovibrio desulfuricans
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How can enzymes help
Enzymes are able to facilitate
biofilm removal from surfaces in
an environmentally-friendly
manner
Enzymes enable targeted
removal of contaminants from
surfaces without causing
deleterious effects to the
surface (e.g., pH-sensitive
membranes and temperaturesensitive surgical instruments)
Enzymes may be able to bypass
bacterial defense mechanisms
that can inactivate common
cleaning agents (e.g., bacterial
catalases for H2O2)
.
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NOVOZYMES PRESENTATION
Multi-enzyme solution can help detergents
remove biofilm
THE SURGICAL
INSTRUMENTS
WERE SOAKED
FOR 60 MIN AT
40°C
Unsoaked
Soaked in
detergent
Soaked in
detergent +
multi-enzyme
solution
L* Values for Soaked Coupons Containing
Pseudomonas Auerginosa biofilm
This data is based on
the removal of Model
Pseudomonas
auerginosa
biofilm, a common
microbe found on
surgical instruments
20
L*
18
16
14
12
Detergent+E2
Detergent+E1 Detergent only
Treatment
No Soaking
,
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NOVOZYMES PRESENTATION
Comments on disinfection
NHS statement on
disinfection
“It is not considered
acceptable to use
Glutaraldehyde for
endoscope disinfection in
the United Kingdom.”





* A program under the British health authorities.
** Danish recommendations from SSI ( Statens Serum
Insititut) and statistics from ESGE and WGO
***Recommendations from the Center for Disease control
(CDC), the Association for the Advancement of Medical
Instrumentation (AAMI) and Association of practitioners in
infection control (APIC) and WGO.
Disinfection is a separate step of the
reprocessing of the flexible Endoscope
The specific substance used for
disinfection varies around the world due to
different recommendations in the different
countries
One of the most commonly used
disinfectors globally for endoscopes is
Glutaraldehyde followed by Peracetic acid
Glutaraldehyde is an asthmagen and there
is a rising concern, especially in the West,
about the use of this substance
Glutaraldehyde is still the most used
disinfector in the rest of the world**, while
the US authorities recommend that you do
not use unless its absolutely necessary***
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The different disinfectors – categorized
Disinfectant base
Properties
Examples
Alkylating agents
• Superior materials
compatability
• Tend to be in a higher
COSHH Essentials hazard
group than oxidising agents
• Their ability to fix protein
may limit use of some
products (e.g
glutaraldehyde)
• Glutaraldehyde (Cidex,
ASEP, Totacide)
• Ortho-phthalaldehyde
(OPA, Cidex-OPA)
• Mixtures (Gigasept rapid,
Septo DN)
Oxidising agents
• Superior sponcidal activity
• Tend to be in a lower
COSHH Essentials hazard
group than oxidising agents
• May be incompatible with
some endoscopes
• Chlorine-containing
compounds (Sterilox,
Tristel)
• Peroxygen compounds
(Virkon S)
• Perasetic acid (Nu Cidex,
Steris, Aperlan)
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