Minncare Cold Sterilant - Product Training

COPYRIGHT
MAR COR PURIFICATION
Minncare Cold Sterilant
Minncare cold sterilant A to Z
4/5/2018 1
COPYRIGHT MAR COR PURIFICATION
Presentation Content
1. Introduction to disinfection
• What is antimicrobial agent?
• Selecting an appropriate antimicrobial agent.
• Sporicidal agent
• Cleaning against disinfection
2. Minncare Cold Sterilant
• Chemistry
• Biocidal activity
• Toxicity assessment
• How to handle Minncare?
3. Applications of Minncare
• Reverse Osmosis and distribution loops
• Room decontamination
• Surface Disinfection
4/5/2018 2
Introduction to Disinfection
4/5/2018 3
What are Antimicrobial Agents?
Antimicrobial agents are substance or mixtures of
substances used to destroy or suppress the growth
of harmful microorganisms whether bacteria, viruses
or fungi on inanimate objects (e.g. walls and floors)
and surface
Footnote: Environmental Protection Agency US EPA definition
http://www.epa.gov/oppad001/ad_info.htm
Classification of Antimicrobial Products
Sterilizer (Sporicides): Used to destroy or eliminate
all forms of microbial life including fungi, viruses, all
forms of bacteria and their spores.
• Type of sterilizers includes:
a) Steam under pressure (autoclaving)
b) Low temperature gas (ethylene oxide)
c) High energy radiation (Gamma rays)
d) Liquid chemical sterilants (Minncare, Actril)
 Disinfectants: Used on hard inanimated surfaces and objects
to destroy or irreversibly inactive infectious fungi and bacteria
but not necessarily their spores.
• Types of Disinfectants
a) High level disinfectant: Kill all viruses and vegetative cells, but they may not
kill endospores reliably.(E.g. Hydrogen Peroxide, Formaldehyde).
b) Intermediate level disinfectants: Destroy all vegetative cells including
Mycobacteria, fungi, and most, but not all viruses. They cannot kill
endospores. (E.g. Alcohols)
c) Low level disinfectants: Destroy vegetative bacteria, except Mycobacteria,
fungi and non‐enveloped viruses. (E.g. Quaternary ammonium compound)
 Sanitizers: Used to reduce, but not necessarily eliminate,
microorganisms from the inanimate environment to levels
considered safe as determined by public health codes or
regulations.
• Type of Sanitizers
a) Food contact products: Dishes and cooking utensils, equipment and utensils
found in food processing plants.
b) Non‐food contact products: Carpet sanitizers, air sanitizers, laundry
additives, in‐toilet bowl sanitizers.
 Antiseptics and Germicides: Used to prevent infection and decay by
inhibiting the growth of microorganisms. Because these products
are used in or on living humans, they are thus approved and
regulated by US FDA.
Descending Order of Resistance to Antimicrobial Agents
BACTERIA SPORES
Geobacillus stearothermophilus
MYCOBACTERIA
Mycobacterium tuberculosis
High Level Disinfectant
NON‐LIPID OR SMALL VIRUSES
Sterilant
polio virus
FUNGI
Intermediate Level
Aspergillus species
VEGETATIVE BACTERIA
Low Level
Staphylococcus aureus
LIPID OR MEDIUM‐SIZED VIRUSES
influenza virus
Commonly Used Disinfectant
Product Advantages Disadvantages
Alcohol Acceptable odor, less to no Limited biocidal range,
residue, low cost flammable, volatile
Quaternary Ammonium Inexpensive Non sporicidal and Limited
biocidal range, residue
Phenols Inexpensive Non sporicidal and limited
biocidal range, residue
Hydrogen peroxide Broad spectrum, less to no Stability, corrosive to
residue, relatively inexpensive copper, brass and zinc
Bleach‐ NaOCl Broad spectrum Corrosive, irritant to skin
Formaldehyde Broad spectrum Carcinogenic, residue
Glutaraldehyde Broad spectrum Carcinogenic, residue
Peracetic acid Sporicidal , less residue, Sour smell, not stable
environmental friendly when diluted
4/5/2018 9
Sporicidal agents
USP 29 NF‐24 <1072> Lists the Effective Sporicidal Agents:
• Aldehydes (e.g. Formaldehyde)
• Bleach (e.g. sodium hypochlorite)
• Ozone
• Peroxides (e.g. Hydrogen Peroxide)
• Ethylene Oxide
• Peracetic Acid (PAA)
USP 29 NF‐24 <1072> Sporicidal Agents
• Aldehydes: Most of them are listed carcingenic
• Bleach(hypochlorites): Concern with being corrosive
• Ozone: Toxic and concern with material compatibility
• Hydrogen Peroxide: Sporicidal but at higher concentration
• Ethylene oxide: Toxic
• Peracetic acid: Strong oxidising agent and effective at low
concentration. Listed as a potential Cold Sterilant
4/5/2018 11
Cleaning the Environment
To Clean or not
to Clean?
• Cleaning is often confused with Disinfection
• Disinfection is NOT a cleaning processing
Cleaning is the Most Important Step
to Successful Disinfection
Mouthwash
Toothbrush
Cleaning versus Disinfection
Cleaning Disinfection
Removal of particulate Kill microbes by saturate and
and dead microbes from the penetrate the cell wall
surface.
Removal of Residues and Concern with particulate,
buildup that can and irregular surfaces
complicate Disinfection
Effectiveness is related to Effectiveness is related to
mechanical action contact time
Minncare® Cold Sterilant
Minncare is
Registered with US
EPA and is classified
as a Sterilant. It kills
all form of
microorganism.
Minncare® Chemistry
CH3COOH + H2O2
Acetic Acid Hydrogen
Peroxide Equivalent
CH3COOOH H2O
+
Peracetic Acid Water
CH3COOH O2 H2 O
+ + After Disinfectant
Acetic Acid Oxygen Water
Benefits of Minncare®
• Superior Biocidal Activity
• All Components are Ultra‐pure, Pharmaceutical Quality
• US EPA (Environment Protection Agency) Registered
Sterilant
• No Heavy Metal Trace Contamination / Stabilizers.
• Biodegradable – Decomposes to Acetic Acid, Water and
Oxygen
• No Toxic Aldehyde Type Vapors, Easy to Vent
• Validated Residual Vapor Detection System
Minncare® Biocidal Activity
Minncare® is a potent antimicrobial agent
and is effective against a broad spectrum of
microorganisms, including:
Bacteria Yeast and Molds
Mycobacteria Virus
Bacteria Spores
Minncare®Biocidal Activity
Activities of the Most Important Biocides

Bacteria Myco-
Biocides Gram -- Gram + bacteria
Spores Moulds Yeasts Virus
Alcohol (70%) ++ ++ + ++ ++
Alcohols ++ ++ 0 0 ++
Chlorine +++ +++ ++ ++ ++
Glutaraldehyde +++ +++ ++ + +++ ++ ++
Hydrogen Peroxide +++ +++ ++ ++ + + 0
Iodine +++ +++ ++ ++ ++ ++ ++
Peracetic Acid +++ +++ ++ ++ ++ ++ ++
Quatenary Ammonium +++ +* 0 0 + + +
* Not active on Pseudomonas
Chart based on internal testing and report by Guyader, 1996

Minncare®
Mechanism of Action
1. Free oxy‐radicals are
produced. Cell Wall
Disruption
2. Cell wall disruption
(breaking bonds in cell
walls).
3. Ruptured walls causes
organism to die
Minncare® Mechanism of Action
Antibiotics versus Minncare
Microbial Resistance
USP 29 NF‐24<1072> confirm that the development of microbial

resistance to disinfectants is less likely.
2 reasons
1. Disinfectant are more powerful biocidal agents than
antibiotics
2. Disinfectant are applied in high concentration against low
popoulations of microorganism usually not growing actively.
In practice, using a Cold Sterilant there is no need for rotation
because a so agent is validated for destroying all form of
microbiological life.
Minncare®
Mechanism of Action
“NO CHANCE”
For Micro‐Organisms to Build
a Resistance
Minncare®
In Vitro Aqueous Testing
Minncare®
AOAC Sporicidal Test
Deactivation of Organisms by
Minncare® Vapors
Minncare®
Environmental Testing (Safety)
• Oral toxicity
• Inhalation Toxicity Testing
• Skin Irritation
• Mucous Membrane Sensitivity Tests
• Dermatological Testing
• IV Toxicity Testing
Minncare®
Toxicity Assessment Summary
How to handle Minncare
• Minncare contains 22% Hydrogen Peroxide and 4.5% Peracetic acid.
• Minncare is highly oxidisable, corrosive and NOT compatible with
chlorine.
• Always put on personal protective gears such as full face shield,
gloves and mask, when handling Minncare.
• Minncare is to be used diluted only with purified water at room
temperature.
• Once diluted it must be consumed within 24 hours.
• When diluting Minncare, always add Minncare to water.
• Unused Minncare is recommended to be first neutralized with
sodium bicarbonate before discharge. The mode of discharge
depends on local requirement.
Minncare Application
4/5/2018 30
Minncare for water System Disinfection
• Material Compatibility
– Determine the materials of Construction on the ultrapure water treatment system
– Minncare is NOT compatible with copper and brass
• System Cleaning
– Create a simple clean‐in‐place (CIP) system
– If RO membranes Involved
• Minnclean® AC or TF (generally speaking AC is used most often)
• Rinse the Minnclean® solution and verify by measuring PH
– IF a Process System
• Clean with Non‐Foaming Detergent
• Determine the hold‐up volume
– For system disinfection, typically prepare 1% ~3% of Minncare®
• Mix Minncare in system
– Measure Concentration using 1% test strips
• Allow Minncare to contact in the system
– Recirculate, Soak, Recirculate and continue to measure concentration
• Flush Minncare out of the system
– Disconnect the CIP and flush out thoroughly
– Measure residual concentration using residual test strips
Chemical sanitization‐ Disinfectant comparison efficacy
Exposure Minncare Formaldehyde NaOCl H2 O2

Time (1%) (2%) (0.001%) (0.2%)
0 minutes 2.3 x 106 2.3 x 106 2.1 x 106 2.0 x 106
15 minutes 1.1 x 106 2.3 x 106 2.2 x 106 2.3 x 106
30 minutes 3.0 x 101 2.1 x 106 1.1 x 106 2.3 x 106
60 minutes <10 2.0 x 106 4.0 x 104 2.0 x 106
2 hours <10 1.5 x 105 1.0 x 104 2.0 x 106
4 hours <10 1.2 x 105 1.0 x 103 1.5 x 106
6 hours <10 1.0 x 103 <10 1.0 x 106
12 hours <10 <10 <10 1.0 x 103
24 hours <10 <10 <10 <10
D-Value 6 minutes 113 minutes 69 minutes 250 minutes
6D-Value 36 minutes 678 minutes 414 minutes 1500 minutes
Chemical sanitization‐ Disinfectant comparison efficacy
Exposure Time Minncare (1%) H2 O2 (5%) H2 O2 (10%)

0 minutes 2.3 x 106 2.1 x 106 2.0 x 106
15 minutes 1.1 x 106 2.0 x 106 2.0 x 106
30 minutes 3.0 x 101 2.0 x 106 2.0 x 105
60 minutes <10 1.0 x 105 <10
2 hours <10 <10 <10
4 hours <10 <10 <10
6 hours <10 <10 <10
12 hours <10 <10 <10
24 hours <10 <10 <10
D-Value 6 minutes 22 minutes 11 minutes
6D-Value 36 minutes 132 minutes 66 minutes
Minncare Test strips
• 1% Test Strips to determine
that enough disinfectant is in
the system and to determine
that the disinfectant has been
removed from the system
Residual Test Strips use the residual test
strips to verify when Minncare® has been
rinsed from the system. Note: multiple
color changes are indicated on the
package for the user to establish time
required in a system to achieve particular
levels of residuals.
34
4/5/2018
Minnclean® Chemicals for RO Cleaning
• Chemicals to
maintain the
quality of your RO
membranes and
distribution
system
35 4/5/2018
Determine When to Clean
Test Data Feed Waste Product
Flow (gpm) New Now New Now New Now
TDS (ppm)
Temp. (F)
Pres. (psig)
36
4/5/2018
Determine When to Clean
• 10% Rule‐‐‐If the membrane performance changes by
more than 10%, it will be difficult if not impossible to
effectively cleaned the RO. There fore, as these conditions
approach 10% clean the RO;
– 10% loss in product water flow
– 10% increase in Run pressure
– 10% loss in product water quality as indicated by:
• increase in TDS
• increase in conductivity
• decrease in resistivity
37
4/5/2018
Identify the Foulant
Flow
Low Normal High
Hardness Hardness Membrane

Scale Scale (light) Damage
Low ----
% Iron
Rej. Silt Membrane
Normal ---- ---- Damage
Biofouling (light)
38
4/5/2018
Cleaners for Possible Causes of Fouling
• Hardness scaling • Minnclean® AC
• Iron • Minnclean® AC
• Bio‐fouling • Minnclean® TF
• Silt • Minnclean® TF
• Membrane damage • Cleaner won't help
• Inadequate pretreatment • Minnclean® TF or AC
(depending on problem)
39
4/5/2018
Methods of Room Decontamination
• Manual process
– Wipe, mop, spray
• Heating process
– Vapor generators
– Heating plates
• Cold process
– Wet fogging
– Dry fogging
Comparison of Various Clean Room Decontamination
Technique
Technique Advantages Disadvantages
Manual Wiping, •Cheap method •Very labor intensive
mopping, spray •No production interruption •Variable in chemicals application
Vapor Generators •Automatic process •Heavy capital investment cost
•Required to control humidity and
temperature prior to disinfection.
Heating plates •Very low equipment cost •Limited in coverage.
•Relatively labor intensive.
Wet fogging •Equipment is relatively low in •Condensation likely to occur
cost •Dispersion of fog is limited
Dry fogging •Good dispersion of fog •Fogging condition is dependant on
•Cover large area effectively humidity and room temperature
Comparison of Wet to Dry Fogging
10µm 100µm 1000µm
300µm
Semi-
Ultra-Fine Fine Semi- Coarse
Coarse
Atomization Atomization Fine Atomization
Atomization
Dry Fog
(under 10µm) Fine Mist
(10µm~100µm) Fine
Drizzle
(100µm~
300µm) Light Rain Thunderstorm
(0.3mm~1.0mm) (Over 1.0mm)
Comparison of Wet to Dry Fogging
Small droplets bounce and Large droplets burst and

do not burst upon collision. make things wet.
Using Minncare Dry Fog as an Example

Benefits of Minncare
• Listed by USP as an effective Sporicide
• Registered in EPA as a Cold Sterilant
• Effective & fast at low concentration
• Safe for the users (water, Oxygen, Acetic Acid)
• Safe for Equipment at low concentration
• No residual left on the surfaces (biodegardable)
• Can be used as liquid form (water system disinfection)
• Can be used as vapor form (airborn room decontamination)
• Manufactured according to Bio‐Pharma Specifications
Mar Cor Purification
Filtration, Water & Disinfection Technologies
Competent
Consistent
Compliant

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COPYRIGHT

Activities of the Most Important Biocides

Chart based on internal testing and report by Guyader, 1996

USP 29 NF‐24<1072> confirm that the development of microbial

Exposure Minncare Formaldehyde NaOCl H2 O2

Exposure Time Minncare (1%) H2 O2 (5%) H2 O2 (10%)

Flow (gpm) New Now New Now New Now

Low Normal High

Hardness Hardness Membrane

Small droplets bounce and Large droplets burst and

Using Minncare Dry Fog as an Example

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