Process Engineering Consulting

Process engineering in
agitation and homogenization technology

1. Which standard must be observed during process engineering

  • CE conformity
  • Pressure vessels e.g. PED 97/23/EC/AD2000-HPO, TÜV - Certificate EN 729/2, ASME U-Stamp etc.
  • Power supply - voltage e.g. - 400 V , 50 Hz
  • Control voltage e.g. 24 V DC
  • ATEX approval
  • Temperature max. Product
  • Ambient conditions - temperature - humidity etc.
  • Steam pressure
  • Compressed air pressure
  • Cooling water °C
  • Quantities of cooling water
  • etc.

2. Size and performance of the process plant

  • What quantities are to be processed and in what time.
  • Which products/product types are to be produced.
  • Which viscosities are to be processed
  • Unpressurised operation
  • Vacuum-tight design
  • Pressure-resistant design ( e.g. for sterilization)
  • GAMP – compliant design - cGAMP - EC GMP

3. Specify choice of materials for product contact areas

  • Areas with product contact
  • Areas without product contact
  • Scraper materials
  • Sealing materials
    • Properties and durability
  • Other requirements
  • Material test attestation - certificates
    • without
    • Factory certification 2.2
    • Certificate 3.1 (b)
    • Certificate 2.2 und 3.1 (b)

4. Surfaces

  • Areas with product contact e.g.
    • Ground K 320
    • Mechanically high-gloss polished Ra 0,6
    • Electro-polished
    • Other requirements
  • Areas without product contact

5. Machinery

  • Scraper material: e.g.
    • PTFE
    • Delrin (POM)
  • Anchor agitator with scraper agitator
    • Agitator seal
    • Vertical mixing
    • Left- right rotation
  • Protective equipment
  • Hot Cold production – saving on production times
    • Self-priming system
  • Homogeniser
    • Type of sealing
    • Water-cooled motor
    • Sealing liquid systems
      • monitored
      • cooled
      • forced circulation
  • Equipment options for the circulating line according to requirements, such as:
    • Nominal width of the circulating line
    • Flow
    • Conductivity
    • Pressure
    • Ph value
    • Viscosity
    • Sampling
  • Equipment options in the lid area according to requirements:
    • Ventilation
      • Filter
      • Sterile air filter
    • Vacuum / pressure / nitrogen blanketing
    • Safety equipment
    • Automatic pressure and vacuum control
    • Powder intake
      • Hose qualities
    • Liquid intake
      • Hose qualities
    • Dosing vessels / Active agent vessels
    • Dosing of different raw materials
    • Hand-hole openings / Manway openings
    • Sampling
    • Intake valves for solids and liquids
    • Automatic dosages
  • Equipment on the vessel
    • Two-zone heating
    • Hopper scales
      • Decoupling the scales
  • CIP – Cleaning equipment
    • Pipes and valves
    • Stationary cleaning equipment built into cover
    • Rotating system underneath the cover
    • Fully-automatic CIP / SIP cleaning
  • Suction device
  • Cover lock Depending on requirements with
    • Safety clamp lock
    • Locking and venting valve
    • Or with screwed-on machine covers
  • Cover lifting device
    • Machine bases
      • hydraulic
      • electric
  • Other accessories/equipment

6. Measuring devices

  • Temperature
  • Pressure
  • Flow
  • Ph value
  • Conductivity
  • Particle size measurement
  • Viscosity measurement
  • Other measuring devices

7. Energy

Heating – cooling controls

  • Heating direct with steam via control valves
  • Secondary heating – hot water circuit heated by steam, via control valves
  • Secondary heating – Hot water circuit electrically heated
  • Temperature measurements - Product / Heating circuit
    • Regulation strategies
      • Temperature difference regulation - Delta T regulation

 Timer-controlled heating and cooling – Ramp function

8. Vacuum control

  • Water ring vacuum pumps from 2m³/h to 400 m³/h
  • Pressure and vacuum regulation

9. Wiring

  • Cable protection system

10. Controls

  • Manual
  • Semi-automatic – fully automatic process chain procedures
    • Process steps can be individually controlled
  • Control e.g. Siemens S7 - Rockwell
  • Visualization systems e.g. - Siemens Win CC - Wonderware in Touch HMI
  • Touch colour display
  • IPC – Touch – colour display, schematically visualized, error analysis
  • Diagnostic system
  • Recipe method -
    • scaling - up – capable system
  • Recipe management
  • Batch report
  • Historical and real-time trends
  • High degree of automation
  • Validatable processes
  • Process control concept with FDA-compliant user management
  • FDA 21 CFR Part 11 - compliant electronic process data recording

11. Quality assurance

Qualification concept

  • URS – User requirements
  • RS – Requirement specification
  • RA – Risk analyses
    • DQ Design qualification
    • IQ Installation qualification
    • OQ Operational qualification
    • PQ Product qualification
      • including risk analysis
    • Factory certificates
      • Approval certificate 3.1 in accordance with DIN EN 10204
      • Approval certificate 3.2 in accordance with DIN EN 10204
      • Factory certificate 2.2 in accordance with EN 10204: 2004
  • Welding documentation

cGMP / EG-GMP / GAMP- compliant design

12. Documentation

  • CE - compliant machine documentation

Details of homogenization technology of mixers

Depending on the product, attention is to be paid to the following

  • Highly efficient agitator and homogenization system in all speed ranges
  • Fast and easy-to-operate cover with safety locking device
  • Radial and vertical mixing of liquid and semi-solid products
  • Homogenization of small quantities in the vessel
  • Procedure for comfortable suction, as well as dispersion of powders
  • Homogenization internally in the vessel, as well as in the circuit
  • Automatic raising and lowering of the cover and agitator in the case of smaller machine units
  • Pressure and vacuum proof machine design (CIP - SIP - design)
  • Clean and easy attachment of the scraper systems
  • Suction of water and fatty phases after the hot - cold process
  • Control of the heating and cooling processes using different regulation strategies

Depending on requirements, simple touch operation up to fully-automatic recipe and batch control, with GMP – compliant documentation in the case of pharmaceutical applications

The homogenization mixer should provide the following application options

Sterile production (depending on requirements)

Important for the choice of homogenizing mixer

High quality homogenizing mixers, their performance and flexibility can significantly reduce production times and costs. The special efficiency of such agitators is due to a variety of factors: It should, therefore, be ensured that the rotor-stator-system is protected against extraneous parts. The infinitely variable speed adjustment and the design of the agitator, as well as that of the homogenizer, should allow highly efficient agitation and homogenization. Also on this point, care should be taken that the design is GMP-compliant. Intensive homogenization in the vessel as well as in the circulation procedure and homogenization of small quantities should be possible in the agitator. A particularly high value should be placed on clean scraping in the rotation direction change operation. The efficient suction of powder and the dispersion into liquids and semi-solids should be possible without great dust emission in the vessel. According to requirements, a pressure and vacuum-tight design should be considered, in order to ensure consistent qualities. The SIP and aseptic GMP design, as well as the integrated CIP design should be suitable for compliance with all hygiene regulations.

Advantages of product manufacture with multi-vessel process plants

The combination of several processing units in a complete process plant has a number of advantages. In this way individual production phases can already be produced in parallel and subsequently combined into a process. This saves time for production and the cleaning of the plants.

  • Separate vessel for different phases
  • Transfer connections to combine raw products and parts of the finished product.
  • Special CIP and SIP cleaning (cleaning-in-place and sterilizing-in-place) can be integrated into every process unit
  • Parallel use of several vessels and/or agitators offer great possibilities for batch time reduction
  • High machine quality increases end product quality
  • High flexibility allows for more versatility in the production

Efficiency, Flexibility, Quality

For the different phases of a product, individual production components are to be integrated which contribute to the economic efficiency of your production. All plant components should be so installed that production can be carried out independently within sections of the plant. For you, this means optimal time utilization during the production process, as all components can be operated in parallel. Depending on requirements, all components should be equipped with CIP and SIP cleaning devices. All plant parts can, if required, be equipped with measuring, dosing and pumping technology. The transfer of the raw material from the storage tanks  into the plant takes place by means of vacuum or with corresponding transfer pumps. SEEFRIED Verfahrenstechnik GmbH can offer you technical solutions, also for the expansion or conversion of already existing plants.

CIP – Cleaning device

  • Mounted into lid
  • Rotating system underneath the lid
  • Steam melting of fatty components before the cleaning process

Combinable phase vessel

  • Pre-phase vessel for fat and water phases
  • Raw materials supply for automated filling with raw materials (liquid and solid)
  • A variety of measurement units, for example
    • PH - probes
    • Conductivity
    • Pressure
    • Temperature
    • Viscosity meter
    • Flow rate meter etc.

Vessel materials

The parts of the plant in contact with the product should be made of durable stainless steel and meet the product requirements. 

Heating and cooling control

  • Direct and indirect heating systems
  • Direct heating with steam via double casing
  • Zone heating with ramp control optionally combinable, through to fully-automated heating system
  • Steam and hot water direct or via a secondary circuit with heat exchangers

Vacuum control

Vacuum pump automatically creates a vacuum and regulates the pressure in the vessel.

Controls and operation

SPS control by means of a small touch-panel or complete visualization via PC, with recording and recipe procedure according to customer requirements.

SEEFRIED Verfahrenstechnik GmbH can support you in the selection and procurement of the optimal processing engineering for your products.