Big Pay-Off from Automation Investments

Pharmaceutical manufacturing is generally considered a hybrid industry, in that it has major elements of process and discrete industries, often in the same facilities. Manufacturing of ingredients follows normal process procedures, while very sophisticated packaging lines use discrete control. Building control systems that span this divide across multiple production units can be challenging, but successful implementations are worth the effort.

Polpharma is a major manufacturer of pharmaceutical products and active ingredients, and is proud of the fact that it is the largest company with all Polish capital in that vertical, since going private in 2000. Its manufacturing facility is located in Starogard Gdanski, with a trade office in Warsaw and branches in foreign markets. Overall, the company has 2,600 employees.

The Starogard Gdanski facility is one of the largest and most modern drug manufacturing plants in Europe. Here Polpharma manufactures a wide variety of products and forms:

Solid forms include tablets, film-coated tablets, effervescent tablets, sugar coated tablets, and capsules. The annual manufacturing capacity of solid forms is 6 billion units.

Parenteral drugs include injectable preparations in polyethylene packaging and glass ampoules, single- and multi-dose eye drops, nasal drops, infusion fluids, and fluids for external use. In 2005, the company started up a new ampoule filling facility, constructed in compliance with strict GMP (good manufacturing practice) standards for sterile manufacturing.

Active pharmaceutical ingredients (API), with reactor capacity of 320,000 liters. API manufacturing facilities are regularly audited by the FDA.

All manufacturing units in the plant have GMP certificates issued by the Main Pharmaceutical Inspectorate and PIC/S (Pharmaceutical Inspection Cooperation Scheme). Polpharma also offers contract manufacturing services of both drug products and active pharmaceutical ingredients.

Polpharma has used Honeywell control system platforms in various parts of the plant for well over 10 years. Initially it used PlantScape, due to the platform’s ability to integrate hybrid manufacturing facilities, but it was clear that more sophisticated capability was required in areas that still depended largely on manual control.

The larger upgrade efforts began in the mid 1990’s as Polpharma was looking for a solution to control its ASA (acetylsalicylic acid) production line. Plant managers had compiled a list of production obstacles which were added to lost production capacity incidents to drive implementation of a new system. However some manufacturing employees were reluctant to make a change away from their manual procedures.

“We needed a technology facelift — one that would help reduce the large number of issues and stop the lost production capacity,” says Tomasz Hartuna, technical director, Polpharma. “We also had to overcome the reluctance of some staff accustomed to manual operation of the line and distrustful that the new installation could bring any realized benefit.”

Based on experiences with PlantScape, Polpharma turned again to Honeywell. Working with engineers in Honeywell’s Warsaw office, Polpharma selected POMS MES (manufacturing execution system) to increase performance by tightening up reliability of the manufacturing processes. POMS controls and tracks all aspects of production, secures predictable quality, enforces GMP, and provides all necessary historical data for regulatory compliance.

POMS MES provides materials management from receipt of materials to finished products, asset management (electronic logbooks), and process execution, including dispensing, manufacturing, and packaging operations. System data at the facility includes 70 working stations that are integrated with 40 product lines and associated equipment, including an ERP system. Connectivity to Honeywell’s Uniformance PHD process historian and Experion PKS enables full access to plant data.

Cooperation from skeptical operators grew with effective training and implementation of user-friendly human machine interfaces (HMIs). Electronic logbooks and record keeping also removed many tedious processes. Overall operator efficiency has increased due to better and faster access to plant information and the more user friendly interface.

“Because our system is continuously upgraded, we wanted to expand our MES dispensing functionality to our new ampoules production department,” says Hartuna. “We continued the implementation with Honeywell’s Experion PKS in other areas of the company such as fine chemicals production, pilot plant, utilities production and distribution, and waste management.”

Given the competitive nature of pharmaceutical manufacturing, Polpharma’s managers watched the implementations closely and kept a close eye on financial performance. As the projects unfolded, they liked what they saw. “Investment in control systems, as well as in production management systems have the shortest pay back period,” says Hartuna. “When we compared our investments in a Honeywell solution to our detailed analysis done prior to purchase, they almost always outperformed our expectations, justifying our decision and demonstrating that real benefits were higher than expected.”

Author Information

Mark Albano is principal consultant, life sciences and batch center of excellence, Honeywell Process Solutions. Reach him at mark.albano@honeywell.com .

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