Implementing a Cost-Effective Cure for Batch and Sequence Management

Aug 14, 2012
By PharmTech Editors
Implementing a Cost-Effective Cure for Batch and Sequence Management

Q. Our company wants to upgrade its single-product semiworks facility to a midscale production facility capable of producing a variety of regulated products. How can we implement a flexible solution without increasing our project budget?

A. Other companies in similar situations have implemented flexible, cost-effective solutions. For example, a small-molecule API manufacturer wanted to upgrade its single-product semiworks facility to a midscale production facility capable of producing a variety of products. The company needed a scalable solution that would meet regulatory requirements and increased security demands for producing regulated materials and controlled substances. Unfortunately, the existing control infrastructure was based on a hard-coded control system from the 1990s that limited its ability to quickly and easily adjust programming and production, which was a requirement for the company as it moved the facility to multiproduct production. The company worked with its automation partner to identify the best control solution.

Some modern control systems allow users to program batch sequencing and use the controller independently of application servers and software. This independent function allows companies to avoid costly, engineering-intensive custom code or additional server infrastructure associated with large-scale batch solutions. Software is available to configure recipes and formulas directly in the controller without requiring code changes to the system, which helps streamline the implementation of approved changes.

Companies today would like to reduce their use of manual, paper-based batch sheets for detailed processing instructions, but API manufacturing processes often require a high level of detail. In this company’s process, for example, removing a kill solution that deactivates a volatile chemical too soon could significantly impact the entire process. Automated solutions that take these detailed instructions into account can be embedded directly into the control system, which can improve the quality and consistency of APIs and avoid the delays that naturally occur during manual operations.

—John Párraga, global process technical consultant at Rockwell Automation.

If you have a problem with your equipment or process, an industry expert may have the solution. Please send your question to Jennifer Markarian, editor of Equipment and Processing Report, and we may be able to provide an answer in a future issue. All questions will remain anonymous.