EXPERTISE

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Sterilization processes and equipment

steam sterilization, Hot-air depyrogenation, steam-air mixture and superheated water.

  • Steam In Place (SIP), bulk sterilization

Sterile filling lines

Vials, syringes, Ampoules, cartridges:

  • Washing machine

  • Depyrogenation tunnel

  • Filling machine with variety of filling technologies options

  • Stoppering and crimping

  • Usage of ready to fill containers

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Aseptic isolation

  • Classic filling rooms

  • RABS

  • Isolators

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Automatic visual inspection machines

 

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VPHP (Vapor Phase Hydrogen Peroxide) systems

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Homogenizers (particles reduction)

 including in aseptic configuration

  • HPH (High Pressure Homogenizer)

  • Microfluidizer

  • Agitated beads mill

  • Rotor Stator

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Lyophilization

  • Equipment and instrumentation

  • Process control

  • Scale-up

  • Loading and unloading

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Design of sterile suites

Layout, flows (Material, operators, waste), pressure cascades and airflows

  • Materials and built

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Pharmaceutical systems

  • HVAC for clean rooms and aseptic filling rooms

  • WFI \ PW

  • Pure Steam (PS)

  • CIP

  • Compressed air and clean gasses

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General fields

  • Calibration

  • Qualification

  • Process development – Tech Transfer from R&D to production

  • Control and instrumentation

  • Computerized control systems – 21CFR part 11 compliance

Close relationship with leading vendors:

  • Filling lines – Bosch, Optima, B+S, Groninger, IMA, Dara, GF, Shibuya

  • Isolators – Skan, Franz Ziel, Getinge La Calhène, Comecer, Airex

  • Automatic visual inspection machines – Eisai, Seidenader, Brevetti, GF

  • Autoclaves – Fedegari, Bosch-SBM, De-Lamma, Tuttnauer

  • Lyophilizers – IMA, Klee, Hull, Martin Christ

  • Special equipment – Harro Hofliger

  • Process equipment – Nicro, Zeta,

  • Homogenizers:

    • HPH – GEA Niro Soavi

    • Agitated Ball Mill - Netzsch

    • Microfluidics

    • Ytron