Modernisation of the formulation
development laboratory
and the pilot plant
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Summary
The project aimed to reconstruct and modernise the GMP pilot production area and the formulation development laboratory with a total area of approximately 1,000 to 1,200 m2. Due to the expected technological break, before the renovation work began, a safety stock supply for commercial products was manufactured, and laboratory work was partially moved to a temporary area. After the renovation, critical installations (i.e. HVAC, purified water, compressed air and nitrogen) and technological devices were requalified.
The project ended when the GMP certificate for the modernised area was renewed. As a result, the production efficiency of the pilot zone was increased, and the ergonomics of work in the laboratory area were improved.
Key points:
Construction and implementation design
Selection of a general contractor
Construction work
Periodical progress updates to key stakeholders
Requalification of the modernised area
GMP certification
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Marek Cichocki
Founder
20 years of experience in the pharmaceutical industry.
