The challenges of global competition, higher production costs and increasingly stringent environmental standards need to be met by companies in the life-sciences industry. That means streamlining manufacturing processes while minimizing water, energy and material costs.
Challenges for life-sciences companies include managing patent expiration, reducing time-to-market, managing the high level of attrition in the R&D pipeline, reducing cost and productivity within the constraints of compliance, creating sustainable manufacturing processes and addressing the issues created by consolidations driven by mergers and acquisitions.
"Very often a product can fail after $900 million has been spent on it, so there's a huge risk," warned Paul Greene, business manager, global solutions, at Rockwell Automation. "From a cost and pipeline perspective, you're seeing a lot of consolidation. It's creating an enormously diverse manufacturing network. In the pharmaceutical industry, there are potentially harmful byproducts, so we're also seeing a lot more focus on end-of-line treatment."
Three companies shared how they optimized their production and the consequential improvements they realized at this week's Life Sciences Industry Forum at Rockwell Automation Fair 2009 in Anaheim, Calif.
Track-and-Trace at Bosch Packaging Services
Drug counterfeiting has become a major issue for pharmaceutical companies and governments around the world. The threat to patient safety and the economic impact of drug counterfeiting has made this a top priority.
"Just looking at a product doesn't tell you if it's an original or it's a counterfeit," said Sandro Gisler, manager, marketing and product development at Bosch Packaging Services, who related his company's story of creating a track-and-trace solution with mass serialization capabilities in a regulated production environment. "Track-and-trace is the tracking and tracing of products through the supply chain from manufacturing to the end customer. It's used for high-quality requirements, when there's an impact on consumer health and safety, when there's a threat of counterfeits and in case of the need for a full product history."
During manufacturing, each package receives a unique serial number so it can be tracked through the entire process. "It originally starts as a reaction to something negative, but benefits can be realized from it," said Gisler. "It provides proof of origin, identifies and eliminates the introduction of counterfeit products, locates each manufactured product in case of quality problems or recalls, provides supply chain savings through better visibility of inventory and gives detailed market intelligence."
According to Gisler, three levels of functionality must be implemented for track-and-trace. Systematic Printing and verifying numbers on each package. Unique serial numbers are required for mass serialization. And the information has to be entered and maintained in a database.
Bosch has 17 manufacturing and packaging plants around the world with in-depth knowledge of pharmaceutical processing and packaging, as well as longstanding experience in the automotive industry, which has used track-and-trace for years.
Bosch's scalable carton-printing system can be used for print-and-verify mass serialization and product traceability. The Bosch modular concept of printing and control systems can be integrated into new or existing packaging lines or complete production plants of all manufacturers.
The machine that was developed, the CPS High End, is a stand-alone unit to make it easier to validate the component. "The throughput is 400 cartons per minute, and it has a relatively small footprint," said Gisler. "The CPS High End receives cartons from the outfeed belts of the upstream machine. Cartons are then transported through the printing module via a belt system. Once in the infeed zone, the carton is guided between the upper and lower belts. In this area, the carton is printed and print quality is verified."
The serialized solution includes a central FactoryTalk Pharma Suite server and site database, which interfaces to third-party enterprise systems, along with FactoryTalk Pharma Suite clients for rework scanning and high-speed device management on an Ethernet network. The operator must see what happens on the machine, so the HMI was developed with all components, from the camera to the printer, in mind.
MES at F. Hoffmann-La Roche
A Swiss-based pharmaceutical company that's more than 100 years old with 80,000 employees on all continents, F. Hoffmann-La Roche (Roche) chose a global approach to its manufacturing execution system (MES) governance and implementation. "We try to standardize our processes," said Robert Fretz, global head of process automation and MES at Roche, where the global MES program is centrally managed to support local implementations. It includes a global competency center and implementation of standardized supply chain processes. A common, standard MES core application is rolled out at local sites, and the implementation is driven by business objectives.
"We start with a standard vendor system and we add limited customizations to it," said Fretz. "A little more than 10% of the system is customized. We start with a common system specification, and then we hand it over to Rockwell. If there are customizations, they will build them, and then it's handed back to us for testing and acceptance."
MES functionality evolves in incremental steps at Roche, but careful steps are in order, as the MES ultimately will be the only source for all batch review of related GMP data.
"As far as the system architecture is concerned, each machine typically has older controls, or it is a little more process-oriented," explained Fretz. "We connect this to our corporate network through a firewall, which provides functionality for data and drives the MES clients, which are connected to the MES. Around MES, we have a collection of OPC and web servers and a data historian. This is collected to ERP. We also have LIMS, but we do not talk directly to the LIMS."