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Fill-Finish & Aseptic Processing

  • EU GMP Annex 1
  • Aseptic processing
  • Lyophilisation
  • EBR
  • ISA-88
  • ICH Q10

Fill-finish is where drug substance becomes drug product — and where the revised EU GMP Annex 1 has made automation a regulatory requirement, not just an efficiency preference. Our Process Automation Engineers configure DCS and MES for aseptic filling environments as an integrated system: DCS controlling the filling line, the lyophiliser and the supporting process equipment in real time; MES executing the batch recipe, capturing every in-process result and building the electronic batch record that QA needs to release the batch. The two systems are configured to talk to each other — so that a DCS event triggers the correct MES workflow and the batch record reflects exactly what happened on the line, automatically.

Fill-Finish & Aseptic Processing

Where we deliver

  1. 01

    Compounding, Sterile Filtration and Hold

    DCS controls compounding vessel agitation, temperature and hold conditions. MES executes the formulation recipe — excipient additions, concentration targets and chain of identity from drug substance to compounded bulk. Sterile filtration with DCS-managed integrity test sequences and MES-recorded results before filling begins.

  2. 02

    Aseptic Filling

    Vials, Syringes and Cartridges

    DCS controls fill weight, stopper placement, line speed and rejection logic — with in-line weight check integration and automated vision inspection interfaces. MES captures every in-process result in the electronic batch record in real time. We configure the filling line control logic to handle interventions correctly — logging them, categorising them and triggering the review workflow that Annex 1 requires — automatically, not through a parallel paper-based process.

  3. 03

    Lyophilisation Cycle Control

    DCS controls shelf temperature profiles, chamber pressure, primary and secondary drying conditions and end-point determination. MES manages the lyophilisation recipe, cycle documentation and out-of-specification alarm management. We configure lyophiliser control systems so every cycle parameter is recorded automatically, every deviation captured, and the cycle report QA needs for batch release is generated without manual data compilation.

  4. 04

    Stoppering, Capping and Electronic Batch Release

    Filling line integration through DCS — MES capturing the complete batch record from first fill to final inspection and building toward MES-integrated batch release, where the decision to release is supported by automatically compiled, complete and review-ready electronic records.

Next

If this filling suite is being brought into a tech transfer programme, we map the DCS and MES configuration differences between the source and receiving site before any validation programme begins. CQV support available where required.

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