
EXPERTISE

Sterilization processes and equipment ​
steam sterilization, Hot-air depyrogenation, steam-air mixture and superheated water.
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Steam In Place (SIP), bulk sterilization
Sterile filling lines​
Vials, syringes, Ampoules, cartridges:
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Washing machine
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Depyrogenation tunnel
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Filling machine with variety of filling technologies options
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Stoppering and crimping
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Usage of ready to fill containers

Aseptic isolation
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Classic filling rooms
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RABS
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Isolators

Automatic visual inspection machines​


VPHP (Vapor Phase Hydrogen Peroxide) systems

Homogenizers (particles reduction)
including in aseptic configuration
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HPH (High Pressure Homogenizer)
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Microfluidizer
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Agitated beads mill
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Rotor Stator

Lyophilization
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Equipment and instrumentation
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Process control
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Scale-up
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Loading and unloading

Design of sterile suites
Layout, flows (Material, operators, waste), pressure cascades and airflows
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Materials and built

Pharmaceutical systems
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HVAC for clean rooms and aseptic filling rooms
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WFI \ PW
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Pure Steam (PS)
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CIP
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Compressed air and clean gasses

General fields
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Calibration
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Qualification
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Process development – Tech Transfer from R&D to production
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Control and instrumentation
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Computerized control systems – 21CFR part 11 compliance
​Close relationship with leading vendors:
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Filling lines – Bosch, Optima, B+S, Groninger, IMA, Dara, GF, Shibuya
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Isolators – Skan, Franz Ziel, Getinge La Calhène, Comecer, Airex
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Automatic visual inspection machines – Eisai, Seidenader, Brevetti, GF
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Autoclaves – Fedegari, Bosch-SBM, De-Lamma, Tuttnauer
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Lyophilizers – IMA, Klee, Hull, Martin Christ
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Special equipment – Harro Hofliger
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Process equipment – Nicro, Zeta,
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Homogenizers:
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HPH – GEA Niro Soavi
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Agitated Ball Mill - Netzsch
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Microfluidics
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Ytron
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