Applying the predictive reliability method to medical packaging can help companies estimate a failure rate and prevent recalls
The reliability of a medical package production process depends upon maintaining a high performance level over a long time period. Predictive reliability methodology can be used to prevent defects by increasing a given production process’s time to failure and hence increasing its overall reliability. The knowledge sharing between the quality departments of those companies involved in producing medical packages can be very important to ensure the robustness of the production process and its long-term reliability.
Today, at a hospital somewhere in the United States, one patient out of 25 is likely dealing with a healthcare-associated infection. This estimate comes from the Centers for Disease Control and Prevention (CDC), which cites a healthcare-associated infection (HAI) prevalence survey.
The Sterilization Packaging Manufacturers Council (SPMC) of the Flexible Packaging Association recently honored Marie Tkacik for serving as chairperson of its Technical Committee for the last 20 years. Tkacik was elected as its first committee chairperson on July 8, 1994, just after the formation of the SPMC earlier that year. She has been re-elected each year since.
Tkacik is now stepping down as committee chairperson, passing the reins to the recently elected Henk Blom, director of technical service for Rollprint Packaging Products.
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.
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.
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.
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.