On-Line DuraLobe Classic SQ RTP SteriLobe AccuLobe TRA10 TRA20 On-Line DuraLobe Classic...

On-Line DuraLobe Classic SQ RTP SteriLobe AccuLobe

TRA10 TRA20


TRA10 TRA20

Training PresentationTraining Presentation

ApplicationsApplications


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TRA10 TRA20


• 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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TRA10 TRA20


• 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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TRA10 TRA20


• 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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TRA10 TRA20


• Cosmetics & Personal Care– Base Chemical Transfer– Mixing Vessel Feed– Additive Metering– Perfume Addition

• Products– Perfumes– Fragrances– Colours– Thickeners– Stabilisers



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TRA10 TRA20


• 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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TRA10 TRA20


• 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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TRA10 TRA20

Training PresentationTraining PresentationPump applications in the Dairy industryPump applications in the Dairy industry


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TRA10 TRA20

Training PresentationTraining PresentationMilk – tanker truck RTP PumpMilk – tanker truck RTP Pump

Displacement1.28 litres/rev

28.2 Imp gals/100 revs33.8 US gals/100 revs

Differential pressure to 12 barSpeed to 1,000 rpm

Weight only 67 kg (148 lbs)


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TRA10 TRA20

Training PresentationTraining PresentationYoghurt / Fromage FraiseYoghurt / Fromage Fraise

• Pump type: Rotary Lobe• Speed: 50 - 200 rpm • Seal: Carbon/Sic• O-rings: 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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TRA10 TRA20

Training PresentationTraining PresentationQuality tests on Yoghurt when pumping at different speeds.Quality tests on Yoghurt when pumping at different speeds.

Yoghurt type Visc in tank Speed Visc in package

Test type 1 1600 cP 110 rpm 1100 cP


Test type 2 1550 cP 110 rpm 1100




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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TRA10 TRA20

Training PresentationTraining PresentationCream (40% Fat at 4 - 8° C)Cream (40% Fat at 4 - 8° C)

• 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

Pump type: Rotary LobeSpeed: 50 - 200 rpm Seal: Carbon/SicO-rings: EPDM (FDA)


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TRA10 TRA20

Training PresentationTraining PresentationButterButter

Pump type: Rotary LobeSpeed: 30-70rpm Seal: Carbon/SicO-rings: 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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Training PresentationTraining PresentationCheeseCheese

Pump type: Rotary LobeSpeed: 30-300 rpm Seal: Carbon/SicO-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 - QuargCan 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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TRA10 TRA20

Training PresentationTraining PresentationSegments & ApplicationsSegments & Applications


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TRA10 TRA20

Training PresentationTraining PresentationRotary Lobe Pump – The MarketRotary Lobe Pump – The Market

Traditional New DesignBiotechnology

Pharmaceutical

Personal Care

Food, Beverage & Dairy

Paints, Inks & Resins

Pulp & Paper

Industrial & Chemical


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Training PresentationTraining PresentationWhy rotary lobe?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

Std temp: 70º C

(higher with increased

clearances)

Difficult to maintain

Pressures 7 – 15 bars

Standard temp: 150º C

Almost zero

maintenance


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TRA10 TRA20

Training PresentationTraining PresentationWhy rotary lobe?Why rotary lobe?

• Reversible flow• Low mechanical. wear• Can pump solids, crystallizing and abrasive liquids• High temp• High pressure• Cost efficient - LCC


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TRA10 TRA20

Training PresentationTraining PresentationHygienic applicationsHygienic applications

Clean

Cleaner


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Training PresentationTraining PresentationFragile and shear sensitive liquidsFragile 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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TRA10 TRA20

Training PresentationTraining PresentationViscous FluidsViscous 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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TRA10 TRA20

Training PresentationTraining PresentationPump applications in the pharmaceutical industryPump applications in the pharmaceutical industryPump applications in the pharmaceutical industryPump applications in the pharmaceutical industry


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TRA10 TRA20

Training PresentationTraining PresentationWFI (Water For Injection) WFI (Water For Injection)

• 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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TRA10 TRA20

Training PresentationTraining PresentationWFI - commentsWFI - 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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TRA10 TRA20

Training PresentationTraining PresentationWater and USPWater 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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TRA10 TRA20

Training PresentationTraining PresentationCleaning In PlaceCleaning In Place

• Pump type: Centrifugal pump• Speed: 1450-2900 rpm• Seal: Carbon/Sic• O-rings: EPDM


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TRA10 TRA20

Training PresentationTraining PresentationCIP - ReturnCIP - Return

Pump type: Liquid ring pumpSpeed: 1450 rpmSeal: Carbon/SicO-rings: EPDM


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Training PresentationTraining PresentationTypical process to produce biological medicine - Clavulanic

AcidTypical process to produce biological medicine - Clavulanic

AcidStep 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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TRA10 TRA20

Training PresentationTraining PresentationPumps used to produce biological medicine - Clavulanic AcidPumps used to produce biological medicine - Clavulanic AcidStep 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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Training PresentationTraining PresentationTypical process to produce pillsTypical 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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Training PresentationTraining PresentationPumps in the process to produce pillsPumps 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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TRA10 TRA20


Pharmaceutical companiesPharmaceutical companies


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TRA10 TRA20

Training PresentationTraining PresentationPharmaceutical OEM suppliersPharmaceutical OEM suppliers


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Hygiene & EHEDGHygiene & EHEDG


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TRA10 TRA20

Training PresentationTraining PresentationHygieneHygiene

• 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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TRA10 TRA20

Training PresentationTraining PresentationTargets for Sanitary & Hygienic-pumpsTargets 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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TRA10 TRA20

Training PresentationTraining PresentationReasons for hygienic pumpsReasons 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 PresentationTraining PresentationCommon Industry TerminologyCommon Industry Terminology

• 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 PresentationTraining PresentationCommon Cleanability TerminologyCommon 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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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 productsEHEDG 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

EHEDGEHEDG


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Hygienic Class I - Aseptic Class - Hygienic Class II

To be certified according to EHEDGdifferent 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

EHEDGEHEDG


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2. Evaluation design 3. Recommendations for improvement

Improveddesignaccepted

8. Cleanability test

7.Cleanability test

1. Start project

Fail

not accepted

5. Recommendations for improvementFail

not accepted

accepted

6. Cleanability test Pass

Fail

11. Reporting12. Quality control

11. Reporting12. Quality control13. Certification

4. Cleanability test

Aseptic ClassHygienic Class I Hygienic Class II

Pass

Pass

11. Reporting12. Quality control

9. Sterilizability test10. Bacteria tightness test

Pass

Pass

Improveddesign


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Training PresentationTraining PresentationCleaning In Place - TestCleaning In Place - Test

Step 1The sterilised test pump and reference pipe is soiled with soured milkcontaining a thermophilic test strain Bacillus Stearothermophilus

Step 2After 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 3Spore count

- Comparing spore count between pump and test pipe

As clean as a piece of pipe


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TRA10 TRA20

Training PresentationTraining PresentationCleaning In Place - Results of soilingCleaning In Place - Results of soiling


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Training PresentationTraining PresentationCleaning In Place - Test result- not approvedCleaning In Place - Test result- not approved


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Training PresentationTraining PresentationTest Result SteriLobeTest Result SteriLobe

30 30-400.5Reference pipe

<5 <5<20 <10<5 <5

<20 <10<5 <5

<0.8, na<0.8, na

nana

<0.8

SteriLobe Rotary Lobe Pump

Cover, cover sealRotor retainer, retainer sealSIC seal rotorSIC static seal, O-ringInner stainless steel parts

Average discolouration (%)

1.0 bar 2.0 bar

Surface finish[µm RA]

Test object

Result: At least as clean as the straight reference pipe

Approved – Hygiene class I


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Training PresentationTraining PresentationSterilising in place – test aseptic classSterilising 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.


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Training PresentationTraining PresentationBacteria tightness – test aseptic classBacteria 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

Staphilococcus aureusBacillus cereus Pseudomonas diminuta

Magnification 10.000 X


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TRA10 TRA20


Make safe and hygienic choices with Johnson Pump (UK) Ltd.

On-Line DuraLobe Classic SQ RTP SteriLobe AccuLobe TRA10 TRA20 On-Line DuraLobe Classic...

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