Packaging Geared for Change
Analyst predicts process and machinery changes ahead for pharmaceutical packaging operations.
John E. Blanchard
Principal Analyst, ARC Advisory Group
John E. Blanchard
ARC Advisory Group
The pharmaceutical industry is changing dramatically. Advances in science and technology, global sociopolitical price and delivery pressures, the growing counterfeit drug market, global competition, and changing regulatory requirements are some of the reasons for this change. To remain successful, pharmaceutical companies must transform their manufacturing processes and operating methods. They must also exploit the supply-chain potential to increase flexibility, responsiveness, and customer service.
In this decade, many pharmaceutical companies will see more than half of their revenues coming from products that have been commercialized for less than four years. Companies will have more diverse portfolios that include small-molecule chemical entities, large-molecule biological entities, personalized medicines, and highly targeted drugs. Many sites will be manufacturing from fifty to hundreds of products with dozens of recipes each. Many of these new drugs will have only a three- to five-year life cycle.
Packaging machinery design, packaging controls, and packaging operations are undergoing significant changes to meet the requirements of this new manufacturing environment. Manufacturers are requiring smaller, less-expensive, faster, and more-flexible packaging machinery. Changeovers will be more frequent. In fact, entire lines will be reconfigured, requiring more-modular, less-dedicated machines. A single machine will perform the functions that several machines perform today, allowing machines to have more-sanitary, self-contained environments. This reduces the need for expensive cleanrooms, which are difficult and costly to staff and limit flexibility and changeover capabilities. Modularity also helps improve the time-consuming manual cleaning process and reduce the potential for cross-contamination.
Improved machinery design that includes extensive use of multiaxis servos, robotics, and vision systems, as well as standards-based control and information systems, will enable rapid operator-performed, recipe-driven changeovers. These technologies will also allow the machinery to be used for a wider variety of products and packages.
In this inevitable new manufacturing environment, there must be more highly trained, autonomous operators who have on-line responsibility for changeovers, reconfigurations, and equipment maintenance. Equipment must include extensive self-diagnostic and self-maintaining features.
More specific requirements include electronic sensors, actuators, and controls designed to evolving standards and guidelines for batch processing, packaging, and information exchange. Two of the most important are the ISA-88 batch standard and the Open Modular Architecture Controls (OMAC) packaging guidelines. The commonality of these evolving standards and guidelines will be critical to integrating horizontal and vertical packaging operations and integrating packaging operations with processing operations. This in turn will reduce project time and product time to market, increase production synchronization and flexibility, and enable continuous quality verification as defined by FDA’s Process Analytical Technology (PAT) initiative. OEMs will be required to provide “PAT-ready” equipment with all of the sensors, actuators, and control and information systems necessary for this continuous quality verification.
Most new drug manufacturing and packaging requires process analytical technology and electronic batch records to ensure product quality through continuous quality verification. RFID will be applied at the pallet, case, and unit level before 2008. Packaging is beginning to include more-extensive anticounterfeiting features, child- and senior-friendly features, and safety features.
As the primary customer base moves from wholesalers to retailers to affiliated consumer groups, there is more make-to-order multidrug packaging personalized to individual patient needs. More-complicated homecare drug regimens continue to replace doctors office care and include more detailed patient instructions and on-call servicing.