Pharmaceutical 2

Freeze Drying Plant Relocation & Upgrade

A relocation of a freeze-drying plant was required as part of works associated in merging with a publically listed company. As the freeze-drying plant had been running for some years without suitable engineering and/or quality administration the process and required documentation was lacking.

Project Summary

After meeting with management to go through the scope of works a detailed project proposal was put together with 4 phases and appropriate timelines.

Phase 1 (Concept)

Although the plant was an existing plant, we treated this phase as a concept phase where we gathered information, evaluated gaps and looked at opportunities for improvement.

On site meetings were arranged with managers and staff to get an understanding of their roles and responsibilities while gathering crucial information about the process. Once this was complete, a high level project task list was created for review by the working group. Below is a list of the major tasks.

Fig. 1 - Representative image of freeze drying equipment.

Tasks requiring completion prior to Phase 2:

Creating new P&ID’s to accurately map the process and instrumentation for relocation and ongoing plant maintenance.

Creating manufacturing process map with process set points for commissioning and qualification once relocated.

Creating equipment and instrumentation lists with detailed information for relocation and ongoing plant maintenance.

Creating item and line cut in diagrams with isometrics to considerably reduce mechanical contractor time on site.

Creating process workflow instruction manuals with process stage gauges for employees at new location.

Creating software instruction manuals for employees at new location.

Creating quality documents with scheduled calibrations and ongoing maintenance.

Phase 2 (Design)

Phase 2 is where all the requirements listed in phase 1 are completed with appropriate changes to existing designs and other associated documents.

Phase 3 (Installation): Installation of relocated plant.

Phase 4 (Commissioning): Commissioning and handover of plant to client.

Level 1, 488 Victoria Street Richmond VIC 3121 Australia

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03 7033-0211

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