Applications

1. Applications

2. 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

3. 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 Applications

4. 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 Applications

5. Cosmetics & Personal Care Base Chemical Transfer Mixing Vessel Feed Additive Metering Perfume Addition Applications • Products • Perfumes • Fragrances • Colours • Thickeners • Stabilisers

6. 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 Applications

7. Light Industrial Raw Material Transfer Mixing Vessel Feed Formulation Feeding Filling Lines Products Paints & Pigments Oils & Lubricants Glues & Adhesives Chemicals Soaps & Detergents Applications

8. Pump applications in the Dairy industry

9. 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)

10. Pump type: Rotary Lobe Speed: 50 - 200 rpm Seal: Carbon/Sic O-rings: EPDM (FDA) Yoghurt / Fromage Fraise 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

11. 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 1 1600 cP 75 rpm 1300 cP Test type 2 1550 cP 110 rpm 1100 Test type 2 1550 cP 75 rpm 1300 cP Test type 3 1400 cP 110 rpm 900 cP Test type 3 1400 cP 75 rpm 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)

12. 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 Cream (40% Fat at 4 - 8° C) Pump type: Rotary Lobe Speed: 50 - 200 rpm Seal: Carbon/Sic O-rings: EPDM (FDA)

13. Butter Pump type: Rotary Lobe Speed: 30-70rpm Seal: Carbon/Sic O-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.

14. Pump type: Rotary Lobe Speed: 30-300 rpm Seal: Carbon/Sic O-rings: EPDM (FDA) Cheese 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).

15. Segments & Applications

16. Rotary Lobe Pump – The Market Traditional Biotechnology Pharmaceutical Personal Care Food, Beverage & Dairy Paints, Inks & Resins Pulp & Paper Industrial & Chemical New Design

17. 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

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

19. Hygienic applications Clean Cleaner

20. 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)

21. 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?

22. Pump applications in the pharmaceutical industry

23. Pump type: Centrifugal pump Speed: 1450-2900 rpm Material: 316L Seal: Sic/Sic O-rings: EPDM (FDA) WFI (Water For Injection) • WFI (Water for injection) • To rinse system after CIP • As raw material in pharmaceutical production

24. 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.

25. 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.

26. Cleaning In Place • Pump type: Centrifugal pump • Speed: 1450-2900 rpm • Seal: Carbon/Sic • O-rings: EPDM

27. CIP - Return Pump type: Liquid ring pump Speed: 1450 rpm Seal: Carbon/Sic O-rings: EPDM

28. 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)

29. 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

30. 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.

31. 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

32. Pharmaceutical companies

33. Pharmaceutical OEM suppliers

34. Hygiene & EHEDG

35. Hygiene • 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

36. 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)

37. 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

38. 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). Common Industry Terminology

39. 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

40. 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

41. 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

42. Pass Pass Pass Pass Pass 1. Start project Improved design 3. Recommendations for improvement 2. Evaluation design Fail accepted not accepted Improved design 5. Recommendations for improvement accepted Fail 4. Cleanability test not accepted 6. Cleanability test Fail 7.Cleanability test 8. Cleanability test 9. Sterilizability test 10. Bacteria tightness test 11. Reporting 12. Quality control 13. Certification 11. Reporting 12. Quality control 11. Reporting 12. Quality control Hygienic Class I Aseptic Class Hygienic Class II

43. 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

44. Cleaning In Place - Results of soiling

45. Cleaning In Place - Test result- not approved

46. Test Result SteriLobe Test object Surface finish [µm RA] Average discolouration (%) 1.0 bar 2.0 bar SteriLobe Rotary Lobe Pump Cover, cover seal Rotor retainer, retainer seal SIC seal rotor SIC static seal, O-ring Inner stainless steel parts <0.8, na <0.8, na na na <0.8 <5 <5 <20 <10 <5 <5 <20 <10 <5 <5 Reference pipe 0.5 30 30-40 Result: At least as clean as the straight reference pipe Approved – Hygiene class I

47. 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. Sterilising in place – test aseptic class

48. 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 Bacteria tightness – test aseptic class

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