Integrated solutions

STERIGENE offers a complete range of integrated solutions in pure fluids, washing, sterilisation,
decontamination, filling barrier systems and visual inspection.

  • Complete implementation systems: study, design, integration, project follow-up, installation, qualifications,
    preventive and curative maintenance, etc.
  • Examples of integrated solutions:
    • Production – Storage – Distribution of pure fluids
    • Automated cap processing – Palletisation – Automatic loading – Sterilisation
    • Complete aseptic and isolator filling line / RABS
    • Bio-decontamination airlock and sterility test isolator

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    PRODUCTION - STORAGE - DISTRIBUTION OF PURIFIED WATER, WFI WATER OR PURE STEAM

     

     

    Purified water, WFI water and pure steam production equipment

    Capacity: 50 m, 3 km and 5 km (loops), automated management of drawing points, temperatures, pressures and flows

    Storage and distribution of pharmaceutical water through CGMP loops, including QC, layout, startup, IQ, OQ, and PQ

    Plans, layouts, installations and qualifications that are fully modular and tailored to customer requirements

    Manufactured and documented CGMP – FDA – GAMP 5 – 21 CFR Part 11

    Source : www.stilmas.com/turn-key-capabilities

     

    AUTOMATED CAP PROCESSING

    Washing, rinsing, siliconising, sterilising, drying and aseptic transfer of pharmaceutical caps and plungers

    Output under LAF/O-RABs/isolator, in-line (bag with port) or packaged (drum)

    Manufactured and documented CGMP – FDA – GAMP 5 – 21 CFR Part 11 – Thema4

     

    GMP IN PALLETISING - AUTOMATIC LOADING - STERILISATION

    Incorporation of GMP in automatic palletising, loading, sterilisation and unloading (without mechanics in the autoclave chamber)

    Manufactured and documented CGMP – FDA – GAMP 5 – 21 CFR Part 11

     

    COMPETITIVE INTEGRATED SOLUTIONS FOR CONTAMINATION CONTROL

    Inline integration of different processes using a robotic operatorless system ensuring automated production in order to control and reduce contamination.

    Manufactured and documented CGMP – FDA – GAMP 5 – 21 CFR Part 11

     

    COMPLETE LINE FOR THE ASEPTIC FILLING OF GLASS VIALS

    The unidirectional movement of the vials reduces the risk of contamination.
    Automatic washing unit for vials, carpules or syringes: 600 u/min.
    Sterilisation and depyrogenation tunnel divided into 3 chambers: heating, depyrogenation and cooling.
    In-line filling, capping, crimping, labelling, data matrix, and controls (IPC)
    Manufactured and documented CGMP – FDA – GAMP 5 – 21 CFR Part 11

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