Packaging for liquid medicine stresses 'safe' and 'easy': new vials, syringes and IV bags balance your desires for convenience and safety

Food & Drug Packaging, March, 2004 by William Makely

For all medications, but particularly for liquid medications administered in health care settings, the current watchword is safety. Convenience--ease of preparation and administration--is a strong driving force for change, but life- and health-guarding safety takes precedence, especially as more and more medications are administered by patients at home, beyond the reach of institutional checks.

Protecting against needlesticks, improving control of medication administration, ensuring proper dosages, eliminating contamination at the filling source ... packaging is taking an active part in making each of these a reality.

Innovations in packaging for liquid prescription medications abound, especially for the industry's mainstays: vials, syringes and intravenous (IV) bags.

New and improved vials

The most common packaging for liquid medication is still the glass vial. Newer plastic formulations that have replaced glass in cosmetic and personal care packaging have not taken hold here.

Aventis Pharma, for instance, in 2003 invested in a hi-tech new vial packaging line at its Frankfort, Germany facility. Labeling, handling and packaging of vials are all done in a completely different way, speeding production significantly. But the vials used are the same glass units used in the past.

However, "slowly" doesn't mean not at all. BioMerieux Inc., on the other hand, is in the process of converting its entire product line to multi-layer, injection blow molded vials from Owens-Illinois. BioMerieux ranks as the eighth largest biological diagnostics company worldwide.

Also, as reported in Food & Drug Packaging in January, Medical Instill Technologies has developed new plastic vials made of cyclic olefin copolymer (COC) to bring greater control over sterility to injectable medications. The unique vials are molded, then immediately assembled under a laminar flow hood, keeping them sterile until filled through the cap by a non-coring needle. After filling, the cap is sealed using a laser beam.

Since they are filled without ever being opened after molding, the new vial system eliminates opportunities for contamination during production handling.

Blow-fill-seal vials

Blow-fill-seal (BFS) technology also offers a cost-effective alternative to glass vials, which would be prohibitive for the unit-dose packaging for which the technology is most often chosen. BFS produces and fills a package in a single, contained operation, eliminating the cost of glass and the multistage sterilization operations needed in filling a preformed vial.

Today, after about 40 years of use in this country, new resins, designs and closure innovations have taken BFS into new market areas.

Weiler Engineering, a leader in BFS equipment, now offers a modified-atmosphere packaging solution. A blanket of nitrogen is introduced during filling, followed by the application of a modified-atmosphere package or a foil package with an oxygen scavenger.

And, BFS machine manufacturer Rommelag has recently designed a machine that coextrudes vials with enhanced barrier properties.

Convenience in BFS closures

Convenient use is as strong a driver in all medical packaging as security. And it almost always focuses on how the product is accessed. BFS vials have for years used twist-off tabs for easy opening. Recent developments have added increasingly sophisticated and use-specific closures.

Both Weiler and Rommelag, for instance, make machines that can put a luer fitting onto a BFS vial. Rather than using two needles at the use site--one to draw product and a second to inject it--the administering nurse simply attaches a needleless syringe to the fitting, draws product, then attaches a needle for the injection.

Weiler has also patented an insertion technology that adds a tip-type cap or a metal fitment to a BFS vial. The part drops into the vial after filling, then the seal mold makes the part an integral part of the package.

Rommelag makes equipment that adds a shrouded needle to a vaccine vial that remains sterile until the user twists off the top.

Prefilled syringes

The development of prefilled syringes containing exact dosages has streamlined the injection process and conserved medications. Opportunities for contamination, misdosing and medicine waste are virtually eliminated. The attendant savings have led pharmaceutical companies to adopt the new technology, a trend which is accelerating today. The U.S. market for prefilled syringes has been growing at a rate of about 20% per year, and is estimated to continue at 5.6% annually and reach $215 million by 2006, according to research by The Freedonia Group.

Lee Karras, vice president of operations for Baxter Pharmaceutical Solutions, LLC, the largest producer of prefilled syringes in North America, considers that a conservative estimate.

"We have seen some astronomical orders recently," Karras reports. "And when companies begin packaging more vaccines in this way, the growth will take another leap."

The pharmaceutical industry is slow to change, he agrees, "but once companies present one product in a prefilled syringe and see the results, they tend to convert more products to the technology."