Simulation software helps manufacturers optimize barrier properties. Some are strictly materials-based, others help with the
structural design of the container or blister package. One integrated program for blister packaging enables exploration of
the effects of tool geometry, film types, and process conditions before performing stability tests. The ability to estimate
thickness distribution, surface area, and the permeability of thermoformed cavities reduces the need for expensive production-line
trials and minimizes tooling costs ("Pentapharm BlisterPro" blister-design program, Klöckner Pentaplast of America, Inc.,
The "KUKA KR5 Sixx CR" cleanroom robot from KUKA Robotics Corp. (Clinton Township, MI) integrates easily because of its tabletop
design and small size. The device features six axes of motion, a 650-mm reach, a 5-kg payload capacity, and computer-based
control. The unit is rated class 5 according to DIN EN ISO 14644-1 and class 100 according to US Federal Standard 209 E.
Products requiring maximum moisture protection may rely on desiccants. Although desiccants typically are inserted into the
package by dropping a small pouch or canister into the container, today it's possible to integrate the water-vapor-absorbing
material into a component of the container or the container itself. Simulation programs also can help fine tune desiccant
specification ("SimulSorb" modeling service, Multisorb Technologies, Buffalo, NY).
Advances in inhaler design make it possible to abandon chlorofluorocarbon propellants and enable the development of dry-powder
technology and products such as "Exubera" inhaled insulin (Pfizer Inc., New York).
Packaging also enables transdermal delivery. A transdermal patch essentially is a drug-impregnated, pressure-sensitive label
designed to be applied to the body that allows an active ingredient to be absorbed through the skin.
The advent of the prefilled syringe has reduced the chance of mixing errors and contamination during preparation, and dose
mismeasurement. It also simplifies self-injection, saves time for hospital personnel, eliminates needle reuse, and lessens
the chance of needle-related injuries (prefilled syringes, Vetter Pharma-Turm, Inc., Yardley, PA).
Advances in equipment
Equipment advances have increased productivity and reduced costs by offering higher speeds, hygienic design, quick changeover,
low manpower requirements, expedited validation, and automated record-keeping. In addition, many material and container advances
such as prefilled syringes, blow–fill–seal containers, and transdermal products depend on highly customized machines because
drug and package are inextricably linked.
Automation is also now applied to material handling and quality control in the form of an increased use of robots and machine
vision. Robots have even moved into the cleanroom.
In some cases, the cleanroom itself is being replaced by isolator-equipped filling lines that enclose all critical areas and
control the air quality and flow inside to maintain pristine conditions.
Advances in logistics
Once a drug product leaves the manufacturer, it faces a potentially hostile environment. Insulated packaging and refrigerants,
and temperature monitoring devices such as time–temperature indicators and data loggers ensure the safe arrival of sensitive
pharmaceuticals and vaccines.
Some of today's advanced temperature loggers are inexpensive enough to be used for a single trip. Other monitoring devices
combine temperature logging with RFID technology.
Now moving from the pallet and case level to the item level, RFID tagging is most commonly being used to provide the product
information needed to satisfy retailer mandates. RFID also can support the pedigree requirements being put in place by a growing
number of states. Reading item-level RFID tags at each point in the supply chain helps prevent counterfeiting and diversion,
authenticates products, identifies bottlenecks, and provides improved inventory control. RFID systems rely on a customized
combination of tags, readers, and software to carry and capture the item-level data as products move through the supply chain.
What does the future hold?
Packaging innovations have done an outstanding job in improving compliance, preventing medication errors, and discouraging
counterfeiting. These advancements ensure quality for the consumer, and improve productivity and reduce costs for drugmakers.