Monday, March 21, 2011

GMP Pilot Plant Automation Strategies





Recently, most major GMP manufacturing plants will include DCS-class automation because the benefits stated previously can clearly justify the costs. Small manufacturing and pilot plants facilities should also consider value propositions for full recipe control and data management.

• The Automation Investment Economics Have Changed. One of DCS perception is that it is expensive and hard to justify in a smaller facility. Times have changed. The starting price of a typical DCS software and hardware package was $300,000. Smaller applications can be much more economically addressed with the introduction of scalable technology like the DeltaV system. Digital systems are now available starting at $25,000 and can be economical for pilot plants small manufacturing, and even research facilities.

• Reducing Capital requirements. Many of the new biotech companies are currently bringing their first products through regulatory approval and into manufacturing. Initially, pilot plants are often used to meet these production requirements and manufacturing is required to support clinical trials. One advantage in adopting data management and batch automation capabilities in the pilot plant is that the facility will be better able to meet manufacturing needs after the new drug is approved and introduced to the market. A pilot plant’s production capacity may not be an important consideration during clinical trials. But if the pilot plant is used to satisfy production demands after the drug is approved, maximizing the equipment's capacity will be strategic and can delay the requirement to invest more capital for a new major manufacturing plant.

• Improving time to market. Once the new drug production requirements outgrow the capacity of the pilot plant, the product will have to move from the pilot plant to the manufacturing plant. Adopting the same automation strategy in the pilot plant and the manufacturing plant can reduce the cost and time of the transition from the pilot plant to the manufacturing plant. The batch recipes and control strategies will have been developed in the pilot plant, and the cost and time for developing automation for the manufacturing plant will be greatly reduced.



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