Pharmaceutical Pilot Plant: Design, Operations and Scale-up Techniques


Highlights:
  • The use of pilot plant facility allows the development scientist to experiment with comparatively small sized batches and make necessary changes both at the product and process level.
  • The investigations lead to identification of critical features of the process, and subsequent adoption of the appropriate strategies and procedures.
  • Finally, the pilot plant studies achieve the successful transfer of the result of experimental formulation (dosage form) obtained in laboratory (small) to the production (large) scale.

Main functions of the pilot plant:
  • Review of the product formula to evaluate and determine its ability to withstand batch-scale modifications.
  • Selection, approval and validation of raw material specifications.
  • Selection and validation of appropriate processing equipments.
  • Evaluation and validation of process as well as production controls.
  • Transfer of developed process/technology to the shop floor for routine manufacturing.


Design of a pharmaceutical pilot plant facility:
  • A well designed pilot plant facility minimizes the labor, time and cost involved.
  • A team is made up of professionals that are qualified in the field and are expert to plan, decide and take decisions about the final design and layout of the facility.
  • The key factors which influence the design of a pilot plant are – product type, product quantity, and activity-based considerations.
  • Large scale equipment in the pilot plant should approach 25-100% of the capacity of full scale equipment; however a minimum of 10% capacity level is mandatory.


Pilot Plant Scale-up studies:
  • After developing and testing a prototype formulation at laboratory scale, the manufacturing process is evaluated and scale-up to provide sufficient volume of the product, to meet commercial needs.
  • In some cases scale-up may involve a major process change that utilizes processing techniques and equipment, which were either unsuitable or unavailable on a laboratory scale.


Technology transfer to Production:
After carrying out the process scale up activity and obtaining the necessary data, next responsibility of the pilot plant personnel is to compile the various products and process related information obtained during the scale-up and validation of the process, which is covered under the regulatory requirements and transfer the technology to the shop floor for routine manufacturing of the product at commercial scale.

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