A Trace-and-Track Future

PharmaManufacturing.com

Safety and Security Concerns Drive Pharmaceutical Packaging

By Nick Basta, Contributing Editor

Tracking, security and traceability are driving pharmaceutical packaging as they never have before. New packaging machinery and coding technologies promise to improve patient safety, as well as the way that drug companies manage their supply chains.

In June, the U.S. Food and Drug Administration (FDA) proposed a rule that would mandate barcoding, at the unit-dose, for pharmaceuticals dispensed at hospitals and nursing facilities. The following month, the Agency rolled out a new initiative intended to examine technologies that could help secure U.S. pharmaceuticals against a rising tide of counterfeits.

Both moves have important implications for the future of pharmaceutical packaging. Not only is the packaging process becoming far more complex, with increasingly sophisticated IT and control systems, packagers are adapting to stringent oversight by FDA "We've gone from being tin knockers to paper pushers," says Linc Jepson, an executive vice president of equipment supplier and systems integrator NJM/CLI Packaging Systems International in Lebanon, N.H.

"There are many complexities to how pharmaceutical products are packaged, what the packaging media are, and what distribution channels are used, especially in the U.S.," comments Andrew Gill, an analyst with PA Group (Cambridge, U.K.), an industry consultancy. "Nevertheless, the overall direction is clear: the industry is moving toward a structure where there is an identifying code on products, so that they can be tracked from point of manufacture to point of use."

While demand for packaging equipment continues to show healthy growth (Figure 1), the market for pharmaceutical packaging, particularly such unit-dose products as blister packs, is moving at several times the rate of inflation. Unit dose packaging, which includes the blister packs and foil strips typically seen in physicians' sample kits, has long been promoted by equipment vendors in Europe, where most ethical pharmaceuticals are distributed that way.

Blister packs and foil strips offer longer shelf life, due to use of barrier materials that prevent moisture migration, they make it easy to spot tampering, and also manage to meet the twin challenges of being "child resistant" and "senior friendly"--both of which are mandated by the federal Consumer Products Safety Commission (CPSC).

However, unit-dose packaging entails higher equipment and media costs. Since each package is formed, filled and sealed at one station on a packaging line, the operations are more complex than for traditional packaging. "Blister packaging machines" require more precise control, and more work on setting up and validating process parameters," says Howard Leary, vice president of engineering at systems integrator Luciano Packaging Technologies (Somerville, N.J.). "They need specified pressures, temperatures and dwell times for applying and sealing the foil backing. It's more sophisticated machinery that requires a higher level of expertise to operate and validate."

In addition, the whole concept of unit packaging runs against longstanding tradition. Hospitals and large drugstore chains may like its efficiency and traceability, but pharmacists look askance at a system that cuts them out of the distribution process.

Like equipment for blister packs and foil strips, blow-fill-seal (BFS) machines, used for parenteral (liquid-injectable) pharmaceutical products, are only slowly making headway in the U.S. against traditional vial and ampule packaging techniques. With BFS machines, a container or "parison" is blow-molded from a variety of plastics in one section of the machine, then filled with the parenteral product in a next section, and finally sealed, a step that involved closing or cutting off the head of the parison, and attaching some type of cap or cover. The entire process is performed within an isolation chamber and both the parenteral product and process air are filtered to aseptic levels of cleanliness.

One significant advantage of BFS technology is that product codes, lot numbers or other identifiers can be engraved right on the package by using etched molds or pin sets that touch the wall of the parison as it is being molded. "Overall, this makes for a container that is inherently tamper-resistant, and doesn't need labeling to be applied," notes Chuck Reed, sales manager at Weiler Engineering Co. (Elgin, Ill.). Although widely used in Europe and the rest of the world, BFS technology still has made only limited progress in the U.S., notably for respiratory treatments and ophthalmic solutions, he says.

Raising the Bar on Barcodes

Now that unit-dose packaging is starting to gain ground in the U.S., the question is: What type of coding will go on those packages? The FDA's plan to mandate barcoding on most prescription medications followed a year of near-consensus debate, with proponents claiming that unit-dose barcoding would drastically reduce medication errors in healthcare settings. FDA doesn't currently mandate barcoding, but it does expect that hospitals will begin to prefer barcoded unit-dose packages.

The proposed rule would not be enforced before late 2006, so no one expects an immediate wholesale conversion to unit dose packaging. But, as Peter Mayberry, executive director of the Healthcare Compliance Packaging Council (HCPC, Falls Church, Va.), points out, the billions of dollars in expected savings from reduced medication errors will be a strong inducement for hospitals to embrace barcoding. The Council, which exists to promote unit-dose packaging, has advocated barcoding at that level. In addition, the Council has asked the CPSC to clarify its rules on child-resistant design features so that the benefits of unit dose packaging would become more apparent; CPSC announced in August that it would formally study the Council's petition.