PMP News Celebrates 20th Anniversary
|PMP News, March 1999|
Thanks to ISO 11607 and other milestones, medical device packaging has gained definite stature over the last two decades.
In 1993, medical device manufacturers sought packages that would maintain sterile product safety and efficacy, reduce hospital and supply chain waste, and offer cost efficiencies to prepare for healthcare reform.
Twenty years later, the goals are pretty much the same. But the means and methods have definitely changed. “The whole process of developing and testing packaging has become more scientific,” observes Dhuanne Dodrill, president of Rollprint Packaging Products Inc. “Validation is a way of life.”
Dwane Hahn, vice president of sales and marketing, agrees, adding that “we rarely ever heard DOE [Design of Experiments] mentioned 20 years ago, but now it’s almost always part of the design process.”
Quality has become an expectation, says Dodrill. Adds Hahn: “Today, we can measure quality and inspect and evaluate it much better.”
And there has been an increased emphasis on cleanliness and risk mitigation leading to improvements in process control, validation, and supply-chain risk management, notes Jerry Bennish, now president of Oliver-Tolas Healthcare Packaging who in 1993 was with DRG Medical Group and later Rexam Medical Packaging. . . . more
|PMP News, December 1994|
Successful contract packagers have become closer partners with manufacturer clients and have helped them implement new package formats. Contract packagers’ business ebbs and flows with the fortunes and priorities of their pharmaceutical manufacturer customer base.
When pharma companies are launching new products, contract packagers’ expertise and technology can bring them to market quickly and at lower cost. Drug companies often rely on contractors for redundant capacity for handling product demand surges.
Conversely, drug companies with the manufacturing capacity and know how may favor the closer control over operations that comes with in-house-production.
With marketplace opportunities in flux, contract packaging organizations have sprung up, merged, and, in some cases, folded.
Leading contractor packagers today have their thumbs on market trends and manufacturers’ emerging requirements, and often invest in technology one step ahead of customers’ need for it. . . . more
Bar codes have made a difference in healthcare, but they have materialized slowly on unit-of-use packages.
On October 7, 2012, the bar code celebrated its 60th anniversary. And while PMP News is only celebrating its 20th anniversary in 2013, much of our reporting over the years has been on this automatic identification enabler.
|PMP News, October 1997|
In June 1994, PMP News called bar coding “one of the fastest growing technologies in the healthcare industry.” In the article, “Bar Coders Manage the Data Boom,” PMP News reported that “the flock of new bar codes compresses more data in less space, opening a world of opportunities for imprinting information on a package.” The article described “the 2-D Data Matrix Code . . . to encode data in a redundant, ‘checkerboard-like’ format.”
In-line printing has advanced to support variable coding, such as those produced by Bell-Mark’s Intellijet printer.
And today, in 2013, manufacturers in both the pharmaceutical industries and medical device industries are turning to bar codes to position themselves to apply unique identification to saleable or unit-level packages, which many in the 1990s called . . . more
In my look back at 20 years of sterile medical device packaging to kick off our 20th anniversary celebration, I heard some industry members talk about experiencing increased scrutiny from FDA. What has transpired?
There is no question that the 1996 publication of the Quality System Regulation (QS Regulation) clarified medical device manufacturers’ responsibilities when it came to package development and validation. I write “clarify,” though, because the responsibility to ensure that medical device packaging is adequate has been in place since the 1978 regulation that promulgated Good Manufacturing Practices for the manufacture, packing, storage, and installation of medical devices.
For instance, 21 CFR Part 820.130 in the original regulation states that “each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”
The 1996 QS Regulation did not change this requirement, but it did “improve the regulation with the inclusion of design controls for packaging,” states Patrick Weixel, postmarket team leader, Center for Devices and Radiological Health (CDRH). “It stated that packaging must be considered early on in the product design process” . . . more
Compliance packaging has made great strides in the past 20 years, as the health industry has focused attention on promoting the safe and effective use by patients of their medications. Challenged to ensure that the package going into the home is both child-resistant and easily accessible to seniors, suppliers and drug manufacturers have delivered a progression of innovation in package interfaces and structural designs.
|PMP News, November/December 1993, premiere issue|
With compliance formats, drugs are provided in unit-dose blisters, time-marked to help in regimen management, with literature for patient understanding of the drug and disease, and often with directions for finding more assistance. As marketing departments embraced packages’ billboarding space for branding and promotional objectives, cartoned blisters debuted in easy-to-carry shapes and sizes for discretely fitting into daily routines.
Packaging Coordinators Inc. (PCI) was an early advocate of compliance packaging, and its Slide-Pack offered to the market in the 1990s provided a package that resisted access by children yet remained senior accessible. “Non-compliance is a national health problem. And medical researchers and packaging experts concur that compliance blister packaging can improve the prescription-taking practices of millions of Americans,” said PCI president Daniel Gerner in 1997. . . more
Heat sealers have improved by increments and leaps, driven by industry guidance, FDA scrutiny, and the requirements of medical device companies for machines that consistently engender compliant seals. In the past two decades, heat sealer vendors have devised more user-friendly machines that are easier to validate and maintain. With the advent of PLCs and electronic control of sealing processes, packagers could with greater precision set, monitor, and control the sealing parameters of temperature, pressure, dwell time, and speed.
Machines came with monitoring ports for supporting machine calibration and validation for showing evidence that sealing performs consistently to package design specifications with a high-degree of assurance. “The technology has advanced 10 to 15 years in the last five years,” observed Kent Hevenor in 1999, then product manager—laboratory machinery, Sencorp Systems Inc.
“Suppliers have made huge strides in meeting industry demands. Now the question is, is there a more cost-effective and efficient way of doing the same thing? We have to revisit less-expensive ways to accomplish the same thing without compromising quality,” Hevenor said. . . more
20 Years of Automation
Companies have reaped large benefits in automating packaging lines and enterprises, gaining higher production rates, improved efficiency, and lower operating costs. Pharmaceutical and medical device packaging companies have automated manufacturing lines and enterprise-wide systems for insights on businesses’ performance.
20 Years of Inspection