Monday, March 21, 2011

Multi-unit Recipe Control Implementation

A decision needs to be made if multi-unit S88 batch automation will be implemented when planning automation for a life sciences project. It is often saw as a simpler proposition to implement unit-based automation using PLCs only that are delivered with the equipment skids. The following benefits should be evaluated when considering whether a process should include full recipe automation:

• Product quality: Operations that base on people for executing manual recipes are subject to human variability. Processes that sensitive to variations in processing will result in quality variation. Full recipe automation that controls most of the critical processing operations provides repeatable, very accurate material processing. This leads to very highly consistent product quality.

• Improved production: Many biotech processes extremely have long cycle times (some up to 6 months), and are very sensitive to processing conditions. It is not uncommon for batches to be lost for unexplained reasons after completing a large the batch cycle time portion. The more sensitive production and the longer the batch cycle time is to processing conditions, the more batch automation is justified.

• Process optimization: Increasing the product yield can be done by making small changes in processing conditions to improve the biological growth conditions or chemical conversions. Manual control offers a limited ability to implement finely small changes to processing conditions due to the inherent lack of precision in human control. Conversely, computers are precisely very good at controlling conditions. In addition, advanced control capabilities can improve process optimization greatly. This results in lower production cost and higher product yield.

• Recordkeeping: A multi-unit recipe control system is capable to collect detailed records as to how a batch was made and relates all data to a single batch ID. This nature data can be very valuable for QA reporting, QA deviation investigations, and process analysis.

• Safety: Operators spend less time exposed to chemicals when the process is fully automated as compared to manual control. Less exposure to the process usually results in a safer process.

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