The main goal of 8D methodology is to improve quality by eliminating the root cause of a problem. Recently I explained how such methodology could play a role in medical package problem solving; now I’d like to explore its potential for examining recalls and associated returns.
How can we get better at keeping patients engaged when a new medication, therapy, preventative treatment, or monitoring routine is first introduced? Even more pertinent to the Medical Packaging Community, how can our packages get better at it?
This point isn’t limited to patient-facing packaging, of course – the same applies for packaging destined for health care providers as well.
Whether for a fresh startup or a seasoned medical device manufacturer (MDM), it is an outright necessity to ensure that packaging quality systems provide for a stringent operating environment that effectively mitigates the three tiers of risks: patient, compliance, and business. And for challenging such stringency, audits exist. Some may view audits, internal and external, as strenuous events, while others may opine about them as robustness tests.
The ASTM International Committee F02 on Flexible Barrier Packaging is revising several of its standards, including F88, Standard Test Method for Seal Strength of Flexible Barrier Materials, and F1608, Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method). On September 23 and 24, at a meeting in Belfast, the committee will discuss the latest progress in the revision process.
The ASTM International Committee F02 on Flexible Barrier Packaging had a packed schedule at its most recent semiannual meeting, which took place on April 8 to 9 in East Lansing, Michigan. The committee discussed standards that it is in the process of creating or revising, as well as two recently published standards. PMP News spoke to Dhuanne Dodrill, Chairperson of the F02 committee and President at Rollprint Packaging Products, about the new standards that the committee recently published or is working on.
Several regulatory and technical milestones have already been reached during the DuPont Tyvek Medical Packaging Transition Project (MPTP), speakers reported during the May 7 Webcast, “Are You Ready for the DuPont Tyvek Transition?” Speakers included Roseann C. Salasin, Global Marketing Director; Bruce A. Yost, Ph.D., Global Technical Director, Thierry Wagner, Regulatory Affairs Director, Europe, Middle-East, and Africa; Mike Scholla, Global Regulatory Director; and Leslie Love, MDM Specialist.
A few weeks ago I asked a room full of designers to re-think, or “re-design” the way they work. For some of them the assignment seemed to be an odd request. I got several “What do you mean?” looks. I got a sense from even more that they never thought about it before. Design is a process that starts here and ends there, and that’s just the way it is. But “the way we work” is, in itself, a design.
Amcor Flexibles took an unconventional approach to sterile breather bags with the design of its Fortis product line, which launched in February. The bags are made with nylon film instead of polyethylene, and they are sealed with uncoated Tyvek, but without any additional film strips. Both of these features are departures from traditional breather bags, says Tara Ford, Business Development Manager at Amcor Flexibles Healthcare.
Critics always ask why billions of dollars are spent on space missions when millions are starving on “terra nostra.” But even theses critics will agree that space missions have indeed helped find solutions for some of the toughest engineering challenges.
While testing of sterile packaging produced for the DuPont Tyvek Medical Packaging Transition Project (MPTP) continues, the first round of results for pre-sterile and post sterile (at T=0) evaluations for the packages represented in the FDA-accepted transition protocol are nearing completion. As Nelson Laboratories completes testing for the 78 different combinations (also called cells) included in protocol, the testing lab is providing data to DuPont for drafting summary reports to industry.