Manage Ingredients for Efficiency, Traceability

After heavy consolidation in many process industries, manufacturers are adopting automated strategies to better manage batch ingredients in production and raw material stages.

After heavy consolidation in many process industries, manufacturers are adopting automated strategies to better manage batch ingredients in production and raw material stages.
After heavy consolidation in many process industries, manufacturers are adopting automated strategies to better manage batch ingredients in production and raw material stages.

Faced with more stringent regulatory requirements while continuing to strive for improved efficiencies has batch process manufacturers trying a variety of automated approaches to improve ingredient management. Many process manufacturers view tighter integration of enterprise functions with manufacturing execution systems (MES) and automation layers as the ultimate endgame for better management of raw materials and finished products.

In the pharmaceutical industry, enterprise integration and seamless production means continuous processing technology. Advocated by the Food and Drug Administration (FDA) in 2013, this manufacturing approach allows for a “finished drug product to be produced in a continuous stream, as opposed to a series of ‘unit operations,’ such as milling, mixing, granulation, and so forth.” Theoretically, drug production can be continuous from chemical synthesis of the active ingredient through production of the tablets or other dosage form, according to the FDA.

The pharmaceutical-based British Technology Strategy Board created a pilot project in 2010 that involved GlaxoSmithKline, GEA Pharma Systems and Siemens. The project executed oral solids dosage (OSD) manufacturing that includes extended changeover times, disconnected processes, low asset utilization and a long approval process before a batch can be released.

“It was not just a matter of granulating the powder and making a tablet, but—more importantly—generating the information that goes with the tablet to enable real-time release (approval) of the finished product,” says Jan Vugts, managing director of GEA Pharma Systems.

This project implemented SiPAT process analytical technology (PAT) software from Siemens to collect performance-related process parameters, such as a loss on drying or particle size distribution, according to the British research body. A key component was communicating process data to the MES for real-time reporting. A Simatic IT Report Manager produced these process data reports, conforming to 21 CFR11 standards, and provided real-time analysis for quality control.

“The amount of quality-related information that is available now on each tablet is huge,” Vugts says. “Up to now, we knew that a batch was good, but now we can say every tablet is good.” This successful continuous processing project revealed a window of less than two weeks to develop a production process for a new tablet.

Momentum is gaining for PAT. Vertex Pharmaceuticals is now building a $30 million, 4,000-square-foot continuous manufacturing facility in Boston in anticipation of approval for a new cystic fibrosis drug, according to a report from Fierce Pharma Manufacturing magazine. GlaxoSmithKline, Novartis and Johnson & Johnson are also reportedly moving toward commercialization applications.

Pharmaceutical continuous processing is at a transformative moment and installation will take massive investments. However, other process manufacturers are taking different approaches to continuous improvement and better repeatability when it comes to ingredient and raw material management. The ISA-88 framework is providing guidance for legacy plants and more mature industrial networking is enabling disparate control platforms and enterprise systems to connect.

“We’ve got to keep in mind that there are several approaches—a top-down or a bottom-up approach for customers,” says John Parraga, product manager at Rockwell Automation. “Customers need a clear interface between platforms and adhering to standards, such as ISA-95 for MES. These have helped processing applications become more productive and efficient across the enterprise.”

For example, Slovakia-based Saneca Pharmaceutical, a formulation specialist, recently updated its Simatic PCS7 control system and added batch control software for the production of active pharmaceutical ingredients (API). The drug ingredients are produced periodically throughout the year, and Saneca Pharmaceutical wanted more flexibility to be able to move to production quicker.

Compas Automation, a system integrator and MES supplier, removed the drug manufacturer’s fixed programmed algorithms for a specific product and migrated to a multi-product system with simultaneous control workflows for several product batches.

The MES platform, based on ISA-88 standards, allows operators to modify the master recipe now, and set procedures and parameters while including an electronic batch record (EBR) of these changes, according to Saneca. There also is an option to generate production reports through defined templates and data from a historian.

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