Medical Device Link.

PMP News January 2000 Selected Contents

OUR VIEW:
Pediatric Labeling Urged for More Drugs

Pediatric-use labels would provide a lasting guidance for medical professionals who treat infants, children, and adolescents.

SPOTLIGHT:
Expanding Labeling Space
by Sally Lane

Labeling technologies are helping OTC drug and nutritional supplement makers tackle the problem of meeting government requirements while creating brand presence.

SPOTLIGHT:
Preventing a Recall: How to Select the Right Pharmaceutical Printer
by Tom Moore, president, California Litho Co. (Chatsworth, CA)

If drug manufacturers want top-quality, hassle-free, and cost-effective printed materials, they should audit potential printers carefully to ensure that their expectations—as well as FDA's requirements—can be met.

MEDICAL FOCUS:
Putting Standards to the Test
by Erik Swain

With FDA's recent emphasis on validating testing methods, industry is keen on developing standards that could become adopted by the agency.

PHARMACEUTICAL FOCUS:
One-Piece Approach to Economical, Senior-Friendly Closures
by Greg Erickson

One-piece closures help packagers and seniors save on costs and muscle.

PHARMACEUTICAL FOCUS:
Scientific Approach Removes Guesswork from Package Design
by John M. Bitner, manager, Package Design and Development, Searle Technical Operations (Skokie, IL)

Armed with the knowledge of the specific MVTRs required, packaging engineers can design a package that optimally meets product protection levels.

PRODUCT UPDATE:

Labelers Become More Efficient, Versatile, and Economical
Always evolving, labelers have become so versatile that they can operate in almost any environment and print on almost any surface.

Thermoformers Create Packages of All Sizes
Thermoformers process a wide variety of materials and can make both large and small packages.

Films Provide Oxygen, Moisture, and Chemical Barriers
Films need to provide an attractive appearance and a high cost/performance ratio.

Inform, Warn, and Get Attention with Labels
Labels provide the information necessary for sending a product to market, whether they contain single bar codes or layers of instructions.

CASE HISTORY:
Taking the Pain out of Production

A capsule filler with automatic monitoring capabilities enabled a blockbuster drug to reach the market on time.

REGULATORY FOCUS:
Accelerated Aging Protocols Established

ASTM's new standard shows how to set up and conduct an accelerated aging test.

EDITOR'S PAGE:
Are Your Drugs Packaged for the Web?