BioConcept’s Production Process

Air quality control

  • Monoblock
  • 17,000 m3/hour
  • heat, cool, moisten and dry
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Water purification

  • softening
  • reverse osmosis
  • Ion exchange
  • sterile filtration
  • ultrafiltration
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Water supply

  • 1,000L storage of ultra pure water
  • water held at 80oC under circulation
  • vapour generation
  • conductivity control
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Vapour generator

  • ultra pure water
  • vapour and vacuum pump control
  • 2 bars pressure
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Air zone concept

  • production and labs class 100,000 and 10,000
  • clean filling room area class 1,000 and 100
  • door-locking system
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Particle counter

  • monitoring
  • class 100 clean room
  • cooling of autoclaved liquids
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Quality raw materials

  • certified suppliers
  • regular evaluation
  • full traceability
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Weighing procedure

  • calibrated scales
  • documentation
  • accuracy to 0.2%
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Documentation

  • outprint of weighing
  • chemical number
  • date, time and weight
  • lot number
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Media Production

  • chemicals grouped
  • individually dissolved
  • basal media forms foundation
  • supplementation with additives
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Water collection

  • water as well as vapour is collected
  • controlled by a Rotamass system
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Vessel

  • Production Vessels
    330 and 1500 litres
  • CIP/SIP
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Milling and Mixing of powders

  • negative air pressure dust cabinet
  • Drum Hoop Mixer ("Rhönwheel")
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Sampling for QC

  • number of sample pending on lot size
  • cell culture testing
  • sterility testing
  • physio-chemical analysis
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QC

  • cell cultivation
  • different cell lines
  • 3 passages
  • morphology
  • growth performance
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BioConcept
Paradiesrain 14 Postfach 427
CH - 4123 Allschwil 1
 Tel. +41 61 486 80 80
Fax +41 61 486 80 00
e-mail: info@bioconcept.ch
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