Originally Published PMPN
March 2004
NEWS
New Technology Applies Risk Assessment to Blister Packaging |
| The 3-D Smart technology is used to obtain a 3-D scan of a cold form foil cavity for risk assessment purposes. Photo courtesy Prodieco. |
Your blister package has just passed stability testing and your firm is ready to move to product commercialization. Is your production tooling automatically qualified just because your stability tooling worked?
If you’ve been following tradition, it may not be, says Peter Schmitt, founder of
Montesino Associates LLC (Wilmington, DE), a packaging consulting firm. “Most firms don’t use stability tooling for production,” he says. “Until now, they’ve had little guidance on how to qualify (much less validate) the production tooling. While the methylene blue test should identify any immediately leaking seals, it neither ensures long-term seal integrity nor qualifies the production tooling.”
Schmitt says he and his partners have watched pharmaceutical packagers struggle with this issue for years and decided to take action. This January, the firm announced 3-D Smart technology, developed with the help of
Prodieco Pharmaceutical Components (PPC; Dublin, Ireland).
3-D Smart consists of eight modules that use 3-D technology to provide powerful tools to manage risk and minimize cost in the design, specification, and qualification of tooling and process conditions used in blister packaging. By rendering tooling and pharmaceutical products into a fully dimensioned 3-D format, 3-D Smart highlights those variables in blister tooling and process conditions most likely to cause failure. Optimizing those variables before tooling construction (in a 3-D virtual format) not only lowers the risk of failure, but can greatly lower costs, according to Schmitt.
When it comes to comparing stability tooling to production tooling, users can scan both sets of tooling and compare them to demonstrate equivalence and qualify production tools, says David Barker, president of PPC. 3-D Smart provides easy, accurate, and complete comparison of the cavity volume, header volume, surface area, draft angles, depth of draw, sealing area, and even knurl patterns. Each module also includes the services of an expert advisor on blister packaging from Montesino. A new risk-based approach flows from this technology, allowing users to examine and evaluate modifications to the pharmaceutical product dimensions and the package.
“Packagers now have the ability to develop a robust qualification procedure to move cavity designs and tools between stability and production machines based on data. They can reduce or eliminate the need for expensive, time-consuming additional stability testing,” according to Schmitt.
Montesino and Prodieco say the new technology addresses some of the major challenges in blister packaging, especially those faced when developing high-barrier packaging such as Alu/Alu (cold-formed foil), Aclar (PCTFE) structures, and PVdC coatings and structures.
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