prefabrication

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Fabrication

VOGELBUSCH BIOPHARMA develops and supplies tailor-made package units for a large variety of customer requirements. Our prefabrication method relies on the complete pre-assembly of functional units mounted on skids and ready for shipment.

Time is money! In order to keep the period between investment decisions and the launch of a product as short as possible, construction and installation times need to be minimized to. Precise planning using computer-aided facility animation allows us to begin building your process facility even while the construction/adaptation of a building is still ongoing and its rooms are not yet ready for occupation. Prefabrication in specially equipped workshops is the key to high-quality installation work. Keeping assembly and qualification periods on-site short enables customers to realize their projects at optimized costs and accelerated deadlines. In order to boost our prefabrication competency, a new site was built in Vienna. VOGELBUSCH BIOPHARMA is now able to act as a competent one-stop shop for all prefabrication services. 

 

 10tKran

Chromatopgraphy

Chromatography systems are among the most complex functional units in modern biotechnology. Chromatography skids by VOGELBUSCH BIOPHARMA are mobile and flexible solutions for any type of chromatography process. 

Typical features of chromatography skids

  • •Inline dilution of buffers and products and independent pumps for gradient feed mixing
  • •Typically up to 10 process inlets and 5 process outlets 
  • •Sampling points before and after the chromatography column connections 
  • •Mass flow control of flow rates by means of a flow meter mounted after every pump 
  • •Double tube heat exchangers ensure a constant temperature in the product flow before the Chromatography column   
  • •Bubble trap and gas sensors prevent gas bubbles from entering the chromatography column 
  • •Inline filtration can be used to reduce the bioburden
  • •Pressure, temperature, conductivity, pH, UV and flow rates are recorded before and after the chromatography column 
  • Elution can be controlled by pH, UV, conductivity, volume or duration 
  • •Pressure can be controlled for chromatography columns with low operating pressures  
  • Compatible with all standard process control systems  

 

Applications

Most biopharmaceutical production processes use at least one chromatography stage in their downstream purification arrays. Due to their process-specific design, chromatography skids by VOGELBUSCH BIOPHARMA are used all over the world in a large variety of processes. Some of their major applications include the production of dietary supplements, vaccines and medicinal products.

 

Ultrafiltration

Ultrafiltration and diafiltration are essential operations in modern biotechnical production - for the concentrating and conditioning of intermediate products within the downstream process as well as for the final formulation of end products. Ultrafiltration systems by VOGELBUSCH BIOPHARMA are mobile, flexible solutions for various applications based on membrane cartridge systems. 

Typical features of ultrafiltration skids

  • •Circulation/product tank with optimized design for minimal working volumes down to 5% of the nominal volume •
  • Use of specially arrayed low shear rotary lobe pump in sanitary design with double mechanical seals 
  • Modular design suitable for single and multiple cartridge holders 
  • •Suitable for all common types of cartridges
  • •Suitable for cartridge holders with mechanical or hydraulic closing systems
  • •Optimized piping to minimise hold up  
  • •Cleaning tank for preparing and holding cleaning solutions 
  • •All tanks and containers to be employed can be heated or cooled depending on their intended use 
  • •Double pipe heat exchanger for retentate cooling 
  • •All systems are optimized for CIP (cleaning in place) and SIP (sterilization/sanitization in place) - except for cassette holders 
  • •Flow rate control by means of transmembrane pressure (TMP) 
  • •Monitoring of temperature and flow rate on retentate side
  • •Monitoring of UV and flow rate on permeate side and optional monitoring  of pH and conductivity 
  • •Compatible with all standard process control systems  
  • •Other membrane systems (spiral wound, hollow fiber) are available upon request

 

Filtration

Filtration skids by VOGELBUSCH BIOPHARMA are mobile and flexible solutions for a large variety of filtration applications. 

Typical features of VOGELBUSCH BIOPHARMA filtration skids

  • • Modular designs, suitable for a large number of liquid filtration applications 
  • • Flexible designs for applications using single or multiple filter arrays as well as different filter configurations 
  • • Filter lines using

o prefilter and main filter units for bioburden reduction

o depth filtration modules and polishing filters

o Simple adaptation mechanisms permit the use of many different types of filter housings (height-adjustable single or multi-component housings) 

o The skids and all of their components are suitable for CIP (cleaning in place) and SIP (sterilization/ sanitization in place) 

o Optimized skid design for  

      • rinsing and product recovery stages (connections for buffer and water for injection) 
      • separate filter group SIP (prefilters, main filters) 
      • •Filter integrity test for membrane filters 
      • •Monitoring of input and differential pressure 
      • •Monitoring and control of flow rate and volume 
      • •Compatible with all common distributed control systems  

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Application possibilities

All of these liquid filtration methods are used in many different areas of modern biopharmaceutical processes. Due to their process-specific design, filtration skids by VOGELBUSCH BIOPHARMA, are used all over the world in a large variety of processes. Some of their most important applications are the production of antibodies, enzymes and hormones. 

Most biopharmaceutical processes use various ultrafiltration / diafiltration methods in the downstream purification or the processing of end products. Due to their process-specific design, ultrafiltration skids by VOGELBUSCH BIOPHARMA, are used all over the world in a large variety of processes. Some of their most important applications is the production of enzymes, hormones and antibodies. 

Services

Prefabrication

The following quality tests are used:

  • Delivery and installation of stainless steel piping and components 
  • •Welding of stainless steel piping and components 
  • •Welding of piping using orbital welding technology including preparation of records and documentation 
  • Acceptance testing of pipelines subject to mandatory testing according to Art. 32a Pressure Equipment Directive 
  • •Installation by own highly trained and certified personnel 

Sterile technical installations

Reliable quality testing and documentation 

Quality testing - testing technologies and measuring methods:

  • Pressure test
  • Non-destructive weld seam testing PT/VT
  • Ferrite content measurement
  • Surface roughness measuring
  • X-ray testing
  • Wall thickness measurement
  • Positive material identification testing 
  • Residual oxygen measuring equipment

Documentation:

  • Inspection certificates 3.1 according to EN 10204
  • Welding certificates according to DIN EN ISO 9606-1, EN ISO 14732
  • Welding seam records 
  • Ferrite content records 
  • Surface roughness records 
  • Endoscopic image and video recording

 

Gallery

Fertigungshalle2018

10tKran

Hallenhoehe5

Eitnergasse1

Beginn

Hallenhoehe2

Hallenhoehe3

LagerLift

Teilanlage

Wassertanks

Indoor2017

Skid Transport