Sterile Medical Packaging

Risk-Based Decision Making in Medical Device Packaging Engineering

Medical device packaging engineering, like other functional areas, works under constant pressure from new product development (NPD) project timelines. The reasons can range from restricted up-front involvement to ever-changing device designs during the NPD process. And, such a burdened environment mixed with continuously compressing timelines requires individuals to make fast-paced decisions. The decisions referred to are the ones that are often negotiated upon to truncate project timelines to increase speed to market.

Thermoform-Fill-Seal Machine Can Replace Tray Lidding Equipment

When a healthcare product packaging company asked potential suppliers for a thermoform-fill-seal machine that could process high-impact polystyrene, the initial answer was no. The material is typically too rigid for thermoform-fill-seal machines. But Ossid, a manufacturer of packaging equipment, reports that it could do what its competitor could not and worked with the packaging company to develop such a machine. The result, Ossid’s 8000S, can replace a standard tray lidding machine, says Jason Angel, the company’s vice president of sales.


Double-Sterile Barrier Packaging in Tube Format Wins Multiple Awards

Two tube packaging systems for medical implants have been recognized with multiple awards. The systems are unique because medical implants are usually placed in pouches or thermoformed packages, says Olivier Richart, CEO and President at Selenium Medical, which manufactures the SoTube/SoSafe systems.

Applying 8D Methodology to Recalls

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’s Your OOBE?

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. 

Packaging Quality Systems: Preventing the Audit Leak

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. 

ASTM Flexible Barrier Packaging Committee to Update F88 and F1608

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.

ASTM F02 Committee Meeting Highlights New Standards for Flexible Barrier Packaging

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 Milestones Reached in DuPont Tyvek Medical Packaging Transition Project

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.

Working Backwards

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.

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