On-Line DuraLobe Classic SQ RTP SteriLobe AccuLobe TRA10

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Training Presentation
Applications
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Applications
• Food
– Transfer From Holding Tanks
– Vacuum Extraction Duties
– Ring Main Supply
– Processing Through Heat
Exchangers
– Feeding Filling Lines
– Brine Injection
• Products
– Jams
– Mayonnaise
– Coffee Liquor
– Chocolate
– Meats
– Tomato Paste
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Applications
• Beverage
– Mash Tun Transfer
– Fermenter Emptying
– Filter Press Feed
– Pasteurised Feed
– Finings Addition
– Flavour Dosing
• Products
– Juices and Syrups
– Mash
– Wort
– Finings
– Colourings
– Flavouring
– Yeast
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Applications
• Dairy
– Tanker Emptying
– Evaporator Duties
– Fermentation Vat Transfer
– Homogeniser Pressurising
– Fruit Pulp Injection
– Filling Head Feeding
– Chocolate Spraying
• Products
– Milk and Cream
– Yoghurt
– Cheese
– Margarine and Butter
– Fruit Pulp
– Egg White
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Applications
• Cosmetics & Personal Care
– Base Chemical Transfer
– Mixing Vessel Feed
– Additive Metering
– Perfume Addition
• Products
– Perfumes
– Fragrances
– Colours
– Thickeners
– Stabilisers
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Applications
• Pharmaceutical & Biotechnology
– Raw Material Transfer
– Formulation Metering
– Reaction Vessel Processing
– Centrifuge Feed
– Solvent Modification
– Ultra Filter Feed
– Sterile Filling
• Products
– Creams
– Ointments
– Vaccines
– Inhalants
– Blood Products
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Applications
• Light Industrial
– Raw Material Transfer
– Mixing Vessel Feed
– Formulation
– Feeding Filling Lines
• Products
– Paints & Pigments
– Oils & Lubricants
– Glues & Adhesives
– Chemicals
– Soaps & Detergents
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Training Presentation
Pump applications in the Dairy industry
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Training Presentation
Milk – tanker truck RTP Pump
Displacement
1.28 litres/rev
28.2 Imp gals/100 revs
33.8 US gals/100 revs
Differential pressure to 12 bar
Speed to 1,000 rpm
Weight only 67 kg (148 lbs)
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Yoghurt / Fromage Fraise
•
•
•
•
Pump type:
Speed:
Seal:
O-rings:
Rotary Lobe
50 - 200 rpm
Carbon/Sic
EPDM (FDA)
Comments:
Yoghurt are a sensitive product that should be handled with care.
Low speed and low pressures. The viscosity are from 1000 –
3000 cP depending on type. The liquid is thixotropic – and this
means that the liquid has a very low effective viscosity in the
pump of around 20 – 30 cP. The yogurt needs there after to
recover in the package. If the Yogurt been sheared too much,
the quality will be lower.
Typical application and solution:
Supporting filling machinery from Tetra, Q = 4800 l/h, pressure
approx 0,5 bar.
Selection:
SteriLobe SLFS (1.524l/rev) at a speed at 80 rpm
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Quality tests on Yoghurt when pumping at different speeds.
Yoghurt type
Test type 1
Test type 1
Test type 2
Test type 2
Test type 3
Test type 3
Visc in tank
1600 cP
1600 cP
1550 cP
1550 cP
1400 cP
1400 cP
Speed
110 rpm
75 rpm
110 rpm
75 rpm
110 rpm
75 rpm
Visc in package
1100 cP
1300 cP
1100
1300 cP
900 cP
1000 cP
Comment: The viscosity of the Yoghurt is reduced due to the shear action of the lobes from
between 1400 and 1600 cP to 10 – 20 cP. Increased slip around the rotors creates higher
velocities within the pump and therefore higher shear rates.
The Yoghurt will recover in the package and the aim is to make the yoghurt recover as much as
possible.
In the test we could see that with a larger pump the finished quality increased. It's not the slip
itself that damages the Yoghurt, it's more related to speed and shear. But of course, the less slip
– the lower the speed, so low pressure is also important. (larger diameter pipes / short
discharge runs)
110rpm = SteriLobe SLEL (1.099 l/rev)
75 rpm = SteriLobe SLFS (1.524 l/rev)
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Training Presentation
Cream (40% Fat at 4 - 8° C)
Pump type:
Speed:
Seal:
O-rings:
Rotary Lobe
50 - 200 rpm
Carbon/Sic
EPDM (FDA)
•
Comment: The sensitivity of cream depends on temperature and fat
content. The colder and the higher the fat is the more sensitive the
cream is. Viscosity approx 20-30 cP. Avoid sharp 90° bends, use long
radius bends and as low a pressure as possible to decrease the sheer
and the back slip. Rotary lobe pump is a perfect solution at max speeds
of approx 200 rpm.
•
Note; Warm cream (>30°C) with a lower fat content can be pumped
with a centrifugal pump
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Training Presentation
Butter
Pump type:
Speed:
Seal:
O-rings:
Rotary Lobe
30-70rpm
Carbon/Sic
EPDM (FDA
Comments:
Butter at 8° C has a viscosity of approx 40000 cP (variations in viscosity depending
of season and region). The butter is not sensitive to pressure. It's more important
that there are a good feeding of butter in to the pumps suction side. Cavitation and
air bubbles will damage the pump and as well the butter. Ideally a butter trolley
(special double auger feed) should be used to feed the pump.
On the discharge side, long sweep bends should be used with no sudden changes in
direction and non restrictive valves.
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Cheese
Pump type:
Rotary Lobe
Speed: 30-300 rpm
Seal:
Carbon/Sic
O-rings:
EPDM (FDA)
Comments: After the milk has been separated in to curd (cheese) and whey, the curd is very sensitive. To
minimise damage low pressures and shear is recommended (low speeds).
Yellow Cheese (Hard, semi-hard etc)
Curd in whey are relative simple to pump. Pressure should be low to minimize back slip so the whey is not
separated from the curd when it's pumped. A pure curd are very sensitive. Speeds – up to 250 - 300 rpm as
max.
Fresh cheese – Cottage cheese - Quarg
Can contain abrasive spices. A cottage cheeses are very sensitive when it has been produced – contains
“squares of cheese” that should not be destroyed. Wing rotor at 35-50 rpm can be needed. Other types of fresh
cheeses might not be as sensitive as it is supplied as a “paste”. Also consider Wright Pump Single Wing
Other cheese types: Blue cheeses (Roquefort, Danablu). Pasta Filata (Mozzarella), White cheeses (goats
cheese). Melted cheese.
Note: Different membrane filtration processes are used to obtain concentration (Reverse Osmosis), fractionation
(Nano or Ultra filtration), clarification (Ultra or Micro filtration) or sterilisation (Micro filtration).
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Segments & Applications
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Rotary Lobe Pump – The Market
Traditional
Biotechnology
New Design
Pharmaceutical
Personal Care
Food, Beverage & Dairy
Paints, Inks & Resins
Pulp & Paper
Industrial & Chemical
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Why rotary lobe?
•
Thin and viscous liquids (<1 mPas - 1,000,000 mPas)
•
Gentle product handling
•
Easy to clean
•
Accurate – low pulsation flow
•
Process pump 24 hours online - Reliable
Pressures 7 - 12 bar
Pressures 7 – 15 bars
Std temp:
Standard temp: 150º C
70º C
(higher with increased
Almost zero maintenance
clearances)
Difficult to maintain
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Why rotary lobe?
• Reversible flow
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•
•
•
•
Low mechanical. wear
Can pump solids, crystallizing and abrasive liquids
High temp
High pressure
Cost efficient - LCC
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Hygienic applications
Clean
Cleaner
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Fragile and shear sensitive liquids
•
•
Recommendation:
– Low speeds (approx 50-150)
– Low pressures minimal slip – to
minimize concentration of particles
Examples
– Jam with whole berries
– Cottage cheese
– Soup (with particulates)
– Dairy Cream
– Yoghurt
– Yog-fruit
– Polymer
– Corn glue
– Pie fillings (fruit and meat)
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Viscous Fluids
Recommendation:
– Low speeds (approx 50-150)
– Be aware of NPSH
– Be aware of the pressure
Examples
– Butter
– Toothpaste / gel
– Frozen or cold juice concentrate syrup etc
– Tomato puree
– Sausage meat
•
Newtonian – Thixotropic –
Dilatent?
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Pump applications in the pharmaceutical industry
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Training Presentation
WFI (Water For Injection)
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•
•
•
•
Pump type: Centrifugal pump
Speed:
1450-2900 rpm
Material:
316L
Seal:
Sic/Sic
O-rings:
EPDM (FDA)
WFI (Water for injection)
• To rinse system after CIP
• As raw material in pharmaceutical production
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WFI - comments
• WFI is a purified water meeting the highest USP requirements
• Typical WFI application; 85 – 95 C pressure 4 bars
• WFI should always be circulated. It should never stand still
• WFI is so “clean” so it is aggressive….
• (316L) – FDA approved elastomers and seal face of SIC needed
• Polished to 0.5 micron in low carbon stainless steel
• In most cases Pumps needs EHEDG approval
• Other waters such as Distilled water
•Used for lower hygienic needs such as rinsing of equipment or
in production of cosmetics
• Other waters: - Drinking Water, - Purified Water, - Sterile Purified
Water, - Sterile Water for Injection, - Sterile Bacteriostatic Water for
Injection, - Sterile Water for Irrigation, and - Sterile Water for
Inhalation.
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Training Presentation
Water and USP
The United States Pharmacopoeia Convention is a non-profit organization in
Rockville, Md., that sets the standards for drugs. Due to federal legislation, the FDA
enforces these standards. Many of the standards are listed in a publication called
the United States Pharmacopoeia (USP).
The main types of pharmaceutical water are : - Drinking Water, - Purified Water, -
Sterile Purified Water, -Water for Injection, - Sterile Water for Injection, - Sterile
Bacteriostatic Water for Injection, - Sterile Water for Irrigation and - Sterile Water
for Inhalation.
In the pharmaceutical industry each step in the water purification process must be
initially validated. The initial validation process includes extensive monitoring and
documentation of system performance for a period of weeks to many months. The
water treatment system must be continually validated at regular intervals. Action
limits, alarm limits and written procedures for normal operation and action/alarm
conditions must be available for FDA review in addition to performance data.
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Cleaning In Place
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•
•
•
Pump type:
Speed:
Seal:
O-rings:
Centrifugal pump
1450-2900 rpm
Carbon/Sic
EPDM
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CIP - Return
Pump type:
Speed:
Seal:
O-rings:
Liquid ring pump
1450 rpm
Carbon/Sic
EPDM
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Typical process to produce biological medicine - Clavulanic Acid
Step 1) Cultivate (starts under microscope) temp 40-50º C
Step 2) In a mixing tank blend the culture (60%) with acetone (40%) and crushed
shells (used as “filtration flocculent”), temp 5º C
Step 3) Pump the mixture in to a rotating filter to separate in to:
- Homogeneous filtrate of acetone and culture
- Remaining products (shells etc.)
Step 4) Extraction – change from acetone to ethyl acetate in an extraction column.
Step 5) Concentration via evaporator (10-16 passes through the evaporator)
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Pumps used to produce biological medicine - Clavulanic Acid
Step 1) Cultivate / Centrifugal pump
Step 2) Mixing tank / PD pumps for abrasive liquid
Step 3) Pump the mixture in to a rotating filter / PD pumps for abrasive liquid
Step 4) Extraction; C-pump (ethyl acetate); Rotary Lobe (acetone filtrate)
- EHEDG, FDA, 3.1b
Step 5) Concentration; C-pump in; Rotary lobe out - EHEDG, FDA, 3.1b
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Typical process to produce pills
Step 1) Mix raw material – acetone, ethanol or similar solvent mixed with an active
substance (culture).
Step 2) Pump in to a fermentation tank – heating and circulation - over/under pressure.
Step 3) Filtration to purify and take away residue from the fermentation tank.
Step 4) Pump the fermented product (chemically reacted) in to a storage tank.
Step 5) Filtration to concentrate (Ultra filtration).
Step 6) Pump in to a tank with different amines, salt etc. Create crystalline slurry.
Step 7) Pump in to a centrifuge to separate crystals from slurry.
Step 8) Dry the crystals to powder.
Step 9) Powder is granulated with a mix containing cellulose, glycol & sugar that are pumped at a
precise capacity to create the coating.
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Pumps in the process to produce pills
Step 1) Mix raw material; Centrifugal Pump – 3.1b, FDA
Step 2) Pump in to a fermentation tank ; Centrifugal Pump – 3.1b, FDA
Step 3) Filtration to purify; Centrifugal pump – EHEDG, FDA, 3.1b
Step 4) Pump the fermented product; Centrifugal pump – EHEDG, FDA, 3.1b
Step 5) Ultra filtration; Rotary lobe - EHEDG, FDA, 3.1b
Step 6) Create crystal slurry; Rotary lobe - EHEDG, FDA, 3.1b
Step 7) Pump in to a centrifuge; Rotary lobe - EHEDG, FDA, 3.1b
Step 9) Granulate and coating; Rotary lobe - EHEDG, FDA, 3.1b
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Pharmaceutical companies
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Pharmaceutical OEM suppliers
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Hygiene & EHEDG
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Hygiene
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•
•
•
How can we make safe choices?
What do we mean by clean?
Will it meet expectations?
Will my choice be valid in the next 10 years?
Important questions we have to make sure we understand.
•Contents:
• Hygienic terminology
• What is EHEDG?
• Different EHEDG classifications
• EHEDG Test Methods
• JP products according to EHEDG
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Targets for Sanitary & Hygienic-pumps
•Pharmaceutical industry (Human, Veterinary)
•Biotechnology (Up-Stream/Downstream-Processing)
•Fine chemicals (demanding high purity)
•Personal care (lotions, colour and concentrates)
•Food (“Functional Food”, “Nutraceuticals”, Aromas)
•Medical (liquids, artificial blood, plasma)
•Others (Clean room-production)
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Reasons for hygienic pumps
• Food safety, governmental and environmental regulations
• Safe production for high potency drugs
–High value production needs best hygienic equipment and reliable pumps
(qualification/validation)
–No leakage e.g. of high potency drugs (hermetical tightness)
–No cross contamination
• New ways of Production
–Biopharmaceuticals (sensitive, expensive peptides)
–New formulation (Liposome's, Extrusion)
–Purification and extraction techniques with Supercritical Carbon Dioxide
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Training Presentation
Common Industry Terminology
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•
•
•
GMP (Past Manufacturing Practice)
– Founded 1968 by WHO standards for proper methods of handling and
manufacturing drugs.
FDA (Food and Drug Administration)
– Governing body of all food and drug manufacturing plants for compliance
with FDA regulations.
– FDA approved materials to ensure that no toxic contaminants leach into
product.
3A-standards
– Standards to protect dairy and food products from contaminations –
voluntary participation to use 3A symbol.
EHEDG (European Hygienic Engineering & Design Group)
– A consortium of equipment manufacturers, food Industries, research
institutes and public health authorities, founded in 1989 with the aim to
promote hygiene during processing and packing of food, personal care and
pharmaceutical products. Unilever being the prime movers.
– EHEDG gives guidelines for hygienic design.
– Authorised test houses provide certification. (TNO, CCFRA).
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Training Presentation
Common Cleanability Terminology
•
Validation
– To document evidence that a system does what is purports to do.
•
CIP (Clean in Place) – can be validated
– Internally cleaning a piece of equipment “in-line” chemical reactants
followed with water rinse. Bio processing and Parma uses WFI
•
COP (Clean out of place) – can not be validate
– Equipment is disassembled for cleaning
•
SIP (Sterilisation in place) – can be validated
– To sterilise with a saturated clean steam at 121 – 145º C
•
WFI (Water for injection)
– A pharmaceutical quality water used as raw material
– WFI has the highest quality of water purity
•
Aseptic
– Absence of viable micro organisms; sterile
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Training Presentation
EHEDG
EHEDG (European Hygienic Engineering & Design Group)
A consortium of equipment manufacturers, food Industries, research institutes and public
health authorities, founded in 1989 with the aim to promote hygiene during processing and
packing of food products
EHEDG gives guidelines for hygienic design
EHEDG - Guideline for hygienic design
• Avoid metal to metal joints other than welded
• Avoid misalignment
• Avoid contact with screw threads
• Avoid sharp corners
• Avoid risk of condensation
• Surfaces free of imperfections such as crevices
• Surfaces resistant against product, cleaning chemicals and disinfectants
• Surfaces must be easy accessible
• The exterior and interior of equipment and pipe work must be self-drainable and
easy cleanable
As clean as a piece of pipe
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EHEDG
To be certified according to EHEDG
different comparison tests are executed.
The tested equipment is compared with a
reference pipe with 0.5 micron finish
Test methods:
- In-place cleanability
- In-line steam sterilization
- Bacteria tightness
Hygienic Class I - Aseptic Class - Hygienic Class II
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1. Start project
2. Evaluation design
Fail
3. Recommendations
for improvement
accepted
Improved
design
not accepted
Pass
4. Cleanability test
Fail
5. Recommendations
for improvement
accepted
Improved
design
not accepted
Pass
Pass
6. Cleanability test
Fail
7.Cleanability test
Pass
8. Cleanability test
9. Sterilizability test
10. Bacteria tightness test
11. Reporting
12. Quality control
13. Certification
Pass
11. Reporting
12. Quality control
11. Reporting
12. Quality control
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 SQClass
 RTP  SteriLobe  AccuLobe
 Class II
Hygienic Class
I
Aseptic
Hygienic
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Training Presentation
Cleaning In Place - Test
Step 1
The sterilised test pump and reference pipe is soiled with soured milk
containing a thermophilic test strain Bacillus Stearothermophilus
Step 2
After drying; the equipment is assembled in a test rig:
- cold tap-water rinse
- cleaned with a detergent solution; at 63°C,
1.5 m/s for 10 minutes
- cold tap-water rinse
Step 3
Spore count
- Comparing spore count between pump and test pipe
As clean as a piece of pipe
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Cleaning In Place - Results of soiling
 On-Line  DuraLobe  Classic  SQ  RTP  SteriLobe  AccuLobe 
 TRA10  TRA20 
Training Presentation
Cleaning In Place - Test result- not approved
 On-Line  DuraLobe  Classic  SQ  RTP  SteriLobe  AccuLobe 
 TRA10  TRA20 
Training Presentation
Test Result SteriLobe
Test object
Surface finish
[µm RA]
SteriLobe Rotary Lobe Pump
Cover, cover seal
Rotor retainer, retainer seal
SIC seal rotor
SIC static seal, O-ring
Inner stainless steel parts
Reference pipe
<0.8, na
<0.8, na
na
na
<0.8
0.5
Average discolouration
(%)
1.0 bar
2.0 bar
<5
<20
<5
<20
<5
30
Result: At least as clean as the straight reference pipe
Approved – Hygiene class I
 On-Line  DuraLobe  Classic  SQ  RTP  SteriLobe  AccuLobe 
 TRA10  TRA20 
<5
<10
<5
<10
<5
30-40
Training Presentation
Sterilising in place – test aseptic class
• Step 1
• The sterilised test pump and reference pipe are soiled with soured milk
containing a thermophilic test strain Bacillus stearothermophilus
• Step 2
• After drying; the equipment is assembled in a test rig:
– In-line steam sterilization of the pump +120°C for 30 minutes
– Connected to a sterile test system and filled with nutrition that is
circulated two hours per day for 5 days
• Step 3
• Detection of remaining spores:
– If there are no spores detected, the pump is classified to be suitable for
sterilising in-line.
 On-Line  DuraLobe  Classic  SQ  RTP  SteriLobe  AccuLobe 
 TRA10  TRA20 
Training Presentation
Bacteria tightness – test aseptic class
•
•
Step 1)
The pump is soiled with nutrition liquid
– On all places there a leakage can occur as at cover packing, shaft seal and
connections.
– This is repeated two times per day in 10 days days.
– The nutrition liquid is circulated in the pump 2 hours per day and the pump are
manually rotated ten times every time the pump is soiled.
•
•
Step 2)
Detection of micro –organisms
– If there still is no growth of micro-organisms the pump is classified as bacteria tight
Magnification 10.000 X
Staphilococcus aureus
Bacillus cereus
Pseudomonas diminuta
 On-Line  DuraLobe  Classic  SQ  RTP  SteriLobe  AccuLobe 
 TRA10  TRA20 
Training Presentation
Make safe and hygienic choices with
Johnson Pump (UK) Ltd.
 On-Line  DuraLobe  Classic  SQ  RTP  SteriLobe  AccuLobe 
 TRA10  TRA20 
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