Originally Published PMPN December
2004
Viewpoint
Packaging Geared for Change
Analyst predicts process and machinery changes ahead for pharmaceutical packaging operations.
John E. Blanchard
Principal Analyst, ARC Advisory Group
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John E. Blanchard Principal Analyst 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.
Copyright ©2004 Pharmaceutical & Medical Packaging News
