technical specification 1861.98041.30 vacuum .... batch volume: 750 litres geometry and performance...

Belcorp-SRA3000+F_Conn-2000106561-1861.98041.30-Tecspec of 18 Created by: Volker Klaassen Created on: 27/05/2013

TECHNICAL SPECIFICATION

1861.98041.30

Vacuum Production Mixer for high-viscous crèmes, gels, lotions

EKATO UNIMIX SRA 3000

CONTENT 1 UNIMIX Production-Mixer Type SRA 3000 ................................................................................. 2 1.1 EKATO PARAVISC -Agitator ...................................................................................................... 4 1.2 Bowl ........................................................................................................................................... 5 1.3 UNIMIX homogenizer S-JET 2500 ............................................................................................. 6 1.4 Electrical control device .............................................................................................................. 8 2 Documentation ........................................................................................................................... 9 3 Utilities to be provided on site ................................................................................................... 10 4 Exclusions (Not included in scope of supply) ............................................................................ 10 5 Options ..................................................................................................................................... 11 5.1 Draw-in-execution #1 of Homogenizer...................................................................................... 11 5.2 Draw-in-execution #2 of Homogenizer...................................................................................... 11 5.3 Draw-in-execution #3 into vessel bottom .................................................................................. 11 5.4 CIP cleaning system of production vessel ................................................................................ 12 5.5 Vacuum producing aggregate .................................................................................................. 12 5.6 Heating / Cooling unit for the production mixer ......................................................................... 13 5.7 DI water dosing via flow meter ................................................................................................. 13 5.8 Dosing tank 20 l ....................................................................................................................... 13 5.9 Spare Parts for Vacuum Pump ................................................................................................. 13 5.10 Connection of existing UNIMIX Pre-mix vessel F 600, 73224 ................................................... 14 5.11 CIP-pump for one existing UNIMIX fat-premix vessel ............................................................... 15 6 Quality assurance .................................................................................................................... 16 6.1 Design-Qualification (DQ)......................................................................................................... 16 6.2 Factory Acceptance Test (FAT) at EKATO-SYSTEMS ............................................................. 16 6.3 Supervisor Installation .............................................................................................................. 16 6.4 Start up (on site) ....................................................................................................................... 16 6.5 Site Acceptance Test (SAT) ..................................................................................................... 17 6.6 Training of operating personnel ................................................................................................ 17 7 Packing, Transportation ........................................................................................................... 17 8 Appendix .................................................................................................................................. 18


1 UNIMIX Production-Mixer Type SRA 3000 Lid execution (basic machine) SRA (flanged lid) Product viscosity max: 50.000 mPas (appearing viscosity at the agitator) Product density max: 1.300 kg/m³ Working volume: 3.000 litres Min. volume of operation: 150 - 300 litres (depending on viscosity) Min. batch volume: 750 litres Geometry and performance of PARAVISC agitator, S-JET homogenizer, recirculation pipe, vessel etc. are according to BELCORP´s existing UNIMIX machines. 100% scale-up and repeatability to existing formulas and processes is provided. Service voltage Three phase current 440 V 60 Hz, 3-phase A/C Execution Vessel In vertical execution, with welded- on double jacket with built-in guide gills for fluid and gaseous mediums. Against losses of heat the bowl is equipped with insulation made of rock wool and a tightly welded insulation jacket made of stainless steel. Admissible vessel pressure Product vessel: 0...3 bar abs., 133°C Double jacket: 0...5 bar abs., 151°C Design, calculation material selection and production conform to Pressure Equipment Directive PED, 97/23 EG category III, designed to contain fluids Group 2 (not combustible, not corrosive, not poisonous, not explosive). Notified body: German TÜV. The vessel is mounted on 3 legs standing on the floor. Dimension U-frame (approx.): 2184x2184 mm For operation, an operator platform is necessary (platform not included in the scope of supply).

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Materials Product contacted parts: Stainless Steel 1.4404 (AISI 316 L) Cooling jacket: Stainless Steel 1.4301 (AISI 304) Insulation jacket: Stainless Steel 1.4301 (AISI 304) Product contacted seals: Viton Piping and fittings Product contacted parts: Corresponding to DIN 11850/R2 (tube connections DIN 11851/11864/32676) Heating and cooling unit: Corresponding to DIN EN ISO 1127 (tube connections DIN 2501) Surface treatment of the vessel Machine inside:

Product contacted machine parts of vessel ground Ra ≤ 0,8 µm Lid, baffle and agitator ground Ra ≤ 0,4 µm Machine outside:

Cylindrical part of the vessel ground Ra ≤ 0,8 µm Bottom and lid ground Ra ≤ 0,8 µm Welding seams ground, pickled and passivated Agitator and homogenizer drive blasted and provided with a prime and body coat. Colour according to RAL 9002.


1.1 EKATO PARAVISC -Agitator Consisting of agitating tool, shaft, bevel gear reducer and motor. Design: EKATO patented Z-type PARAVISC Design without screws in the product wetted area (according to cGMP, pharmaceutical standard). Due to the PARAVISC design the production mixer is suited for a wide range of viscosities. It guarantees an extremely good vertical mixing. By means of the continuous movement of the product along the wall, short cooling times are achieved. Due to reduced surface area remain consequently less product residues. The PARAVISC has no additional mixing blades, the product room is free of obstacles. This allows for best and quick de-aeration of the product. All UNIMIX units at BELCORP are equipped with the PARAVISC agitator. This allows for achieving very homogeneous product in the complete batch volume and to scale-up heating-cooling and mixing times as well as energy input. Machine model: SRA 3000 Power of PARAVISC agitator: 22 kW rpm of mixing tool (cw, ccw, reverse mode): 7…34 min-1 Rpm of mixing tool step-less controlled by a frequency converter incl. reverse operation mode. Shaft sealing Sealing of the agitator shaft by a 4-fold set of sealing rings. Scraping system Material of construction for product bowl scrapers is PTFE. Design is the EKATO UNIMIX bi-directional pivot-type. For the installation and de-installation of these scrapers no stainless steel safety ring and no screw is needed. The scraper is fixed by a single bolt. Axial forces are absorbed by the scraper support.

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1.2 Bowl

Lid Domed construction, provided with the following ports and connections: 1x PARAVISC agitator 370x45 1x Baffle with temperature sensor 1x Hand- / manhole DN 500 1x Sight glass with double wiper DN 150 DIN 28120 1x Sight glass lamp with timer DN 100 DIN 11851 4x Stud for CIP DN 40 DIN 11864 1x Stud (e.g. for dosing funnel) DN 32 DIN 11864 1x Stud (spare) DN 50 DIN 11865 1x Pressure indicator -1 ... 2 bar g with transmitter (4 ... 20 mA) DN 50 DIN 11864 1x Vacuum (with el.-pn. operated valve and limit switch) DN 65 DIN 11864 1x Venting (with el.-pn. operated valve and limit switch, filter not

included) DN 40 DIN 11864

1x Compressed air / nitrogen (with el.-pn. operated valve and limit switch, filter not included)

DN 25 DIN 11864

1x Safety valve and over pressure protection DN 40 DIN 11865 Vessel wall

Cylindrical, with guide gills and insulation, provided with the following ports and connections: 1x Recirculation pipe (above insulation) DN 150 DIN 11864 1x Pressure release of double jacket (for each zone) G 3/8" ISO 228 1x Cable conduit through insulation 1x Vacuum pipe through insulation Bottom Domed construction, provided with the following ports and connections: 1x S-JET homogenizer 475x51 -/- 1x Bottom draw-in DN 65 SUEDMO 1x Heating / cooling fluid inlet DN 65 DIN 2633 1x Heating / cooling fluid outlet DN 65 DIN 2633 1x Temperatur measuring (see below) Temperature measuring (2x) Product temperature measuring device Pt 100. Range: 0... +150 °C Position 1): in baffle Position 2): in bottom (to ensure proper measurement of small filling

volumes, located in homogeniser inlet, enabling complete scraping of the bottom)

1) 2)


1.3 UNIMIX homogenizer S-JET 2500 cGMP conform high performance homogenizer, designed for applications in pharmaceutical production. According to the rotor / stator principle, located centrically at the bottom of the vessel. Homogenizer model: S-JET 2500 Power (up to 50.000 mPAS): 75 kW Speed of homogenizer: 500 ... 1800 min-1 infinitely variable speed (within the specified range) controlled by frequency inverter. Controlled BTO – numbers (Batch Turn Over), assuring repeatability of product quality and production times, avoiding overheating or breaking of the emulsion. The BTO–concept allows for safe scale-up of the homogenizing time between all UNIMIX units at BELCORP, with the same results in droplet size, droplet size distribution, viscosity, texture, distribution of colour, pigments etc. The homogenizer is adjustable and can work in 2 positions: 100% internal or 100% external:

1) INTERNAL: The product will be homogenized inside the vessel,

re-entry below the product level, radial in parallel to the vessel bottom 2) EXTERNAL: The product is homogenized and pumped via

external circulation pipe into the upper part of the vessel, re-entry above the product level

By operating the respective valves in the circulating pipe the vessel

contents can be discharged.

In both operation modes liquids and solids can be drawn in directly into the rotor-stator system.

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Pressure execution of homogenizer The homogenizer develops a discharge pressure (up to 3 bar) which can be used to discharge high viscous finished product. When this feature is used with a CIP system the result is shorter cleaning cycles and enhanced cleaning efficiency.

Shaft sealing Shaft sealing of the homogenizer is accomplished with a double acting mechanical seal. Mechanical seal faces: Product contacted: SiC / SiC / Viton Atmospheric contacted: SiC / SiC / Viton The seal rings are cooled and lubricated by a mixture of glycerine / water, white oil, etc. The mechanical seal assembly is designed to promote circulation of the cooling and lubricating fluid through a compensation tank. The compensation tank is equipped with: • pressure gauge with two limit contacts (low and high) • two level contacts (low actuating alarm and low/ low stopping

homogenizer) • pressure relief safety valve • cooling coil built into compensation tank, including • valve to open/close the cooling water valve during homogeniser

operation (water saving) Circulation pipe Circulation pipe with electro-pneumatically operated butterfly valves suitable for either external circulating or discharging of the product. Incl. 1x manual sample valve, mounted in the vertical part of the circulation pipe. The sample valve can be flushed with water (even during production). Not included in CIP-circuit. Homogenizer model and size: S-JET 2500 Diameter of circulation pipe: DN 150 UNIMIX Production-Mixer Type SRA 3000 Number of re-entries (above maximum filling level): 1


1.4 Electrical control device consisting of Master Control Cabinet (MCC) electrically wired and equipped with all terminal strips, relays, safety devices, PLC etc., with: • Main power disconnect (lockout) • Power supply: 3 phase AC 440 V 60 Hz • Control voltage 24 V DC • Frequency inverter for PARAVISC agitator • Frequency inverter for S-JET homogenizer • Frequency inverter for vacuum pump • PLC is SIEMENS S7 • Material: epoxy coated carbon steel • Incl. cooling of the control cabinet

Operator Panel (HMI) Made from Stainless Steel, IP69K (inclined top side), including one (1x) separate 15” touch-panel (IP65) incl. visualization acc. to the existing UNIMIX machines at BELCORP. Position: to be defined.

The automation allows for a comfortable and safe operation of the equipment. The following process parameters and machine functions are selected from the operator panel: SRA production mixer: • Homogenizer on / off / speed / operating time • Homogenizer internal / external (S-JET -Homogenizer) • Draw-in function (if available) • Agitator on / off / speed / direction (left-right) / operating time • Discharge • Vessel light • CIP (if available) • Heating and cooling (2 zones) (if available) • Pressure/Vacuum/Venting (if available)

F premix vessel: • See Options.

Single process parameters can be protected with a password. Separate controls incorporated in the Operator Panel • Control power on / off • Emergency stop (mushroom style push button) All alarms will be displayed on the operator interface terminal. Material: Stainless steel. Cables between master control cabinet and operator panel (included) approx.: 30 m ATEX-Conformity / Explosion-proof execution Not considered. Remark: The machine will be installed at approx. 2.600 m above sea level.


Remote control TS-adapter (with included modem) for remote automation maintenance by EKATO SYSTEMS. Direct analogue telephone connection to be provided by the customer. To be connected temporarily to provide fast and direct technical assistance, service and program modification.

2 Documentation According to previously supplied machines to BELCORP: 1 set in paper form, 1x on CD in English/Spanish, including: 1 operator manual (Spanish) 1 functional description (Spanish) / list of components (Spanish) 1 drawings / spare parts list of EKATO SYSTEMS (English) 1 maintenance check list (Spanish) / lubricants and coolants (English) 1 electrical wiring diagram (English) 1 sub-supplier documentation (English; in Spanish if available from sub-supplier) 1 statement of conformity / statement of manufacturer (English) 1 certificates for product contacting parts and seals acc. to EN 10204-2.1 (English) 1 protocols DQ / FAT / SAT (English) 1 calibration / surface / passivation protocols / IQ / OQ (EKATO standard, English) 1 TÜV-documents of vessel, lid and safety valve (English)

Additionally for the production vessel: 1x welder certificates 1x certificates of non-destructive testing of selected welding seams (double jacket and homogenizer flange) More sets, further documents or other languages to be quoted upon request.

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3 Utilities to be provided on site • Electrical power supply (440 V, 60 Hz, 3-phase A/C) • Compressed air (min. 7 bar abs, dry, oil free) , with service valve • Process water, with service valve • Cooling water: max. admissible pressure 4 bar abs, with service valve • Steam or heating water, max. admissible pressure 5 bar abs, with service valve

4 Exclusions (Not included in scope of supply) • Connection of cooling water and steam to heating / cooling unit • Connection of cooling water and condensate from heating / cooling unit • Piping between heating / cooling unit and vessel • Connection of water-feed to vacuum pump • Connection of exhaust from vacuum pump • Piping between vacuum pump and vessel • Connection of compressed air to compressed air supply • Power supply to main control cabinet • Cable trays • Wall-, floor- and ceiling passages • Insulation of the complete piping system • Crane and/or forklift incl. staff to transport equipment from truck to final location • Welding materials/gases • Disposal of packing materials • Workshop room • Operator platform • Dosing function for raw materials, DI-water etc. or signal exchange with

customers utilities supply line or filling machine (if not specifically mentioned) • Air or product filter (if not specifically mentioned) • Any not mentioned item


5 Options 5.1 Draw-in-execution #1 of Homogenizer

A port with a gap free butterfly intake valve (with variable opening angle, oscillating between 2 programmable positions during suction), will be provided directly to the aspirating mouth of the homogenizer. For easy introduction of powdery materials (emulsifiers, thickeners) directly into the inlet of the rotor/stator section of the homogenizer. Lump formation and agglomeration are avoided due to immediate dispersion with the product in the vessel after induction.

5.2 Draw-in-execution #2 of Homogenizer

A second draw-in valve, identically to the previous position will be supplied for suction in of liquids, transfer of fat phase etc. This feature provides the possibility to run HOT/COLD-processes.

Homogenizer model and size: S-JET 2500Diameter of draw-in valve #1: DN 65Diameter of draw-in valve #1: DN 65

5.3 Draw-in-execution #3 into vessel bottom

A draw-in valve located in the vessel bottom. For solid raw materials like crushed apricot kernels, almond shells etc. for exfoliation products, abrasive skin cleanser etc., or liquids for shampoos or lotions. UNIMIX Production-Mixer Type SRA 3000Diameter of draw-in valve #3: DN 65

Options 5.1, 5.2, 5.3: Controls for these options include an alarm contact set to -200 mbar, assuring that the valves close automatically, when pressure inside vessel should increase about this point. It is excluded that the product can flow backwards into the suction hose. Operation of the intake valves via a radio controlled foot switch. Includes 2 x suction lance with false air supply. The workplace for the 3 draw-in functions is at floor level.


5.4 CIP cleaning system of production vessel Consisting of a set of jets incl. connection ports, suitable to work via homogenizer. Execution of jets: Spray ball type. Incl. one electro-pneumatically operated butterfly valve in the circulating line. No necessity to dismount parts for cleaning, no necessity for an additional CIP-pump. CIP Manifold Pipe manifold, that allows the automatic cleaning of the raw material inlet ports and valves on the homogenizer (#1 and #2) and in the bottom (#3). After the discharge of the finished product, the operator connects the CIP manifold manually.

5.5 Vacuum producing aggregate Consisting of a water-ring vacuum pump system with motor and electrical control. The suction capacity is designed for safe, quick and comfortable process and operation when solids are drawn-in, cold phases are added or the product is de-aerated. Max. set value acc. to height of 2.600m (approx. -740 mbar).

UNIMIX Production-Mixer Type SRA 3000Suction capacity at suction pressure of 100 mbar: 245 m³/hMotor vacuum pump (with VFD): 7,5 kW Included are: • Vacuum pump • Separator for air / cooling water • Cavitation protection pipe • Suction site check valve • Valve for cooling water inlet • Needle valve for adjusting of cooling water volume • Check valve to prevent back flow of cooling water • Incl. integration into the control system Piping between pump and UNIMIX production mixer not included (to be executed with flexible pipes, when weigh cells are used). Connection to premix vessel: not included, to be quoted upon request.


5.6 Heating / Cooling unit for the production mixer Pneumatically actuated. Mounted on separate skid, for the heating with steam, cooling with water and automatic water discharge, blow-out before both heating and cooling. Consisting of: • 1 digital temperature controller (included in PLC) • 1 valve with el.-pn. actuator for steam DN 65 • 1 valve with el.-pn. actuator for condensate DN 40 • 1 steam trap • 1 valve with el.-pn. actuator for cooling water inlet. DN 65 • 1 valve with el.-pn. actuator for cooling water outlet DN 65 • 1 valve for air DN 25 • 1 valve with el.-pn. actuator for water discharge DN 65 • 1 safety valve Incl.: Two (x2)-Zone heating Two-zone heating-cooling of 25% or 100% of the bowl of the manufacturing vessel. Incl.: • 3 el.-pn. operated valves for selection of 1 / 2 zones Piping between the rack and the UNIMIX production mixer not included (to be executed with flexible pipes, when weigh cells are used) Counter-flanges to be delivered by EKATO.

5.7 DI water dosing via flow meter DI-water dosing into the production mixer. Coriolis mass flow meter type Siemens Sitrans, nominal diameter DN 40. Including butterfly-valve with variable opening angle in order to reduce recoil in customers loop when closing the valve and 2 diaphragm valves (diameter to be defined). Shut-off valve to DI-water loop: Not included, but controlled from OP. Including programming of dosing function into SRA and F vessel and integration into controls. Position of the stud: to be defined (lid, upper CIP-pipe and sprayballs, homogenizer suction valve for liquids or elsewhere).

5.8 Dosing tank 20 l

Executed with cone-shaped bottom, cylindrical vertical part and flat lid, hinged. With hand operated diaphragm valve.

5.9 Spare Parts for Vacuum Pump

• Rotor and seal for vacuum pump.


5.10 Connection of existing UNIMIX Pre-mix vessel F 600, 73224

Actual connections and components and changes Nr. Size Component Comment

M262 001 Mizer agitator Agitator not changed. Now: two velocities. New: variable rpm from SRA-panel

N8 DN 50 K265 002 manual for CIP Changed to el.-pn.* for transfer from bottom into homogenizer

K266 001 el.-pn. for vacuum Not modified, controlled via SRA-panel

K266 002 manual for venting Changed to el.-pn.*, controlled via SRA-panel

K266 003 el.-pn. for compr. air Not modified, controlled via SRA-panel

K265 081 manual for CIP Changed to el.-pn.*, controlled via SRA-panel

K265 082 manual for draw-in Not modified, sensor added for visualization

V268 150-2, 147 two-zone-heat Not modified, controlled via SRA-panel

*Valve and sensor delivered by EKATO, mounted/welded by customer

This option includes the hardware inside the main electric cabinet (frequency converter) necessary to control the above mentioned functions of Belcorp´s existing UNIMIX F600 premix vessel s. n. 73224 and the visualization and control via the SRA-Operator Panel. Any cables, pneumatic tubes, (safety) valves, valve terminal, terminal box, sensors (if not specifically mentioned), piping between vessels, filters, piping to the vacuum pump, piping to the CIP-pump (pump quoted as option) or part of these items are not included, but can be offered after an diagnose visit at site (see EKATO Service quotation 2000113132).


5.11 CIP-pump for one existing UNIMIX fat-premix vessel A separate CIP booster pump to be delivered. The F premix-vessel and the SRA production vessel can be CIPed independently from each other. For this purpose a pipe manifold is connected between transfer pipe and the CIP-pump. The CIP of the premix vessel is an semi-automatic function. Incl. el.-pn. operated butterfly valves and piping inside the skid borders, using existing connections (quote based on as-built status when machine was delivered. Changes to be informed by customer resp. considered diagnose visit at site). Motor power of the pump: approx. 4,0 kW Electronic soft start of the pump or frequency converter to be quoted after technical clarification.


6 Quality assurance

6.1 Design-Qualification (DQ) The following documents will be checked internally and confirmed/signed by the customer • P&ID and Technical Specification • Unit layout and alignment

6.2 Factory Acceptance Test (FAT) at EKATO-SYSTEMS The equipment will be checked by the customer/user during FIQ and FOQ before shipment. Quoted time: See Price Sheet. Factory Installation Qualification (FIQ) The following tests will be carried out and recorded • Coincidence of installation and P&ID • Identification of the components • Completeness of scope of supply • Coincidence of installation and specification • Coincidence of instrumentation installation and design of the measuring and control

instruments • Coincidence of electrical installation and electrical hardware

Factory Operation Qualification (FOQ) The following test will be carried out and recorded: • Function of all components (vacuum, agitator, homogeniser etc.) with calibrated • measuring instruments • Check unit tightness and discharge ability • Check of signals of all components • Check interaction of controls and function of the unit (demonstration with water) • no product test • Protocol of FOQ

6.3 Supervisor Installation Installation of the equipment in production area Crane and/or forklift incl. staff to unload and transport equipment from truck to final location and erection is provided by others, the supervision (mechanical and electrical) of complete installation is done by EKATO. Quoted time: See Price Sheet.

6.4 Start up (on site)

Consists of: • Functional test with water • Setting of response times and observation intervals • Optimisation of parameter settings • Optimisation of parameter limits • Optimisation of process conditions Quoted time: See Price Sheet.


6.5 Site Acceptance Test (SAT) The approval of the unit and their performance will be given by the customer/user after successful tests according to FIQ and FOQ test procedure. Quoted time: See Price Sheet.

6.6 Training of operating personnel • Done by EKATO SYSTEMS • Based on final documentation • Performance will be recorded in writing • Signed by customer/user • Will be performed during Start-Up and SAT.

Electrical training and on operation as well as training on mechanical maintenance will be realized by the respective EKATO personnel. Additional quoted time for mechanical training and maintenance: See Price Sheet. Additional quoted time for electrical training and operation: See Price Sheet. Process training:

Summarized and periodical training of groups (R&D, TT/PP, Production supervisors and operators) at BELCORP or in Schopfheim in theory and in practice suggested. To be discussed.

7 Packing, Transportation See Commercial Conditions. Travel expenses such as airfare, travel time, rental car, accommodation, meals, etc. are not included in our estimates and will be billed according to the prevailing "Service Rates Schedule". Quoted times are best-estimates, based on 8 daily working hours. Additional time for FAT, Supervision, Start-Up, SAT and Training due to delay not caused by EKATO SYSTEMS or requested by the customer will be charged according to our service rates.


8 Appendix Suppliers EKATO UNIMIX standard accessories will be supplied by: Gearboxes for Agitators: Nord, SEW, SIEMENS Motors: Leroy Somer, SEW, Nord, VEM, SIEMENS Vacuum Pumps: Speck, Nash, Sterling Sihi, Bush Pressure/Vacuum gauges: AB, Labom PLC: Siemens Simatic S7 Butterfly Valves: AWH Diaphragm Valves: Gemü, SED Instrumentation air fittings and tubing: Festo Angle seat globe valve: End, Gemü, Burkert Steam traps: Gestra, Spirax Sarco Mechanical seals: ESD, Burgmann, Flowserve Level sensors: Endress + Hauser, KSR- Kübler Mass-Flow sensors: Siemens (Belcorp request) Conductive-Flow sensors: Endress + Hauser, Krohne Temperature controls/devices: Endress + Hauser, Jumo Agitators, Dispersers: EKATO Fluid, EKATO RMT Steam and compressed air filter: Ultrafilter, Millipore Product filter: Nocado, Pall, Millipore Recording device: Jumo, Yokogawa Limit switches: Pepperl + Fuchs Frequency converter: Siemens (Belcorp request) or similar (the selection of the supplier is to Ekato´s discretion) Photos and drawings in this Technical Specification are examples and not contractually binding.

technical specification 1861.98041.30 vacuum .... batch volume: 750 litres geometry and performance...

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