Check out the archived "radio show" hosted by Karen Greene on the Community Blog-Medical Packaging Innovation. During this radio show Karen Greene discusses a process for the development of a statistically valid sample size for your sterile barrier system validation. The focus is on conducting a risk assessment of your packaging design in conjunction with your medical device design and aligning it with your company's policies on assigning criticality to packaging defects.
6 Benefits of Outsourcing Your Medical Packaging Engineering Activities
We discuss the benefits of using contractors and suppliers to assist you with your business needs for design, development and validation. We paraphrase Albert Einstein-- you can not fix a problem with the same mind that created it. Packaging technical expertise is in relative short supply and utilizing experienced subject matter experts can provide solutions quickly and effectively.
We will be linking regularly to the Medical Packaging Innovation website. This is a new community of professionals dedicated to discussing topics related to medical packaging. This is an international community of packaging professionals and is a great place to visit for relevant topics.
The medical packaging innovation community is interested in experienced professionals for development of blog posts and moderating positions.
In this blog post, we focus on essentials for the successful development of medical device packaging design. Key steps are outlined which help ensure design success for the organizatio and most importantly the consumer of the medical device, our patients!
Let the expert team at Life Packaging Technology LLC assist you with the critical business activities of designing, prototyping and validating sterile medical packaging systems.
Reference our brief presentation on key elements of effective sterile packaging validation :
docs/Package Integrity validation LPT Website 6-12.pdf
Life Packaging Technology LLC now offers tooling and molding consulting services, offered by Mr. Fred Carr, retired, Plastic and Metal Center, Laguna Hills, CA. Let LPT LLC assist you in performing mold and tooling IQ, OQ, PQ qualifications as well as trouble shoot part design and manufacturing issues of both injection molded and thermoformed parts. Mr. Fred Carr holds several medical and dental patents and is a certified ISO internal auditor and representative.
docs/Life Packaging Technology LLC now offers Molding Consultation for Thermoforming and Injection Molding.pdf
HealthPack conference, http://www.healthpack.net 2012- Held in Albuquerque, New Mexico, March 6 - March 8 2012, continues its noteworhty success for educating and enlightening medical device packaging professionals.
This event has developed into the pre-eminent conference for healthcare packaging professionals. Job well done by Curt Larsen, John Spitzely, Ed Landon, Barb Dykes and Carole Schiller.
This year's nurses' survey presented by Ms. Jennifer Blocher of Sealed Air Medical, continues to build on the valuable information of previous surveys regarding practices and perceptions of utilizing sterile medical packaging. Sustainability and recycling issues were surveyed and summarized. Jennifer's survey indicated that there is room for significant development at the clinical site setting for facilitating recycling.
This year's nurses' panel, live critque of sterile medical packaging, expertly facilitated by Ms. Jennifer Benolken of St. Jude Medical, continues to entertain, educate and enlighten the HealthPack conference crowd.
Hat tip to Pharmaceutical and Medical Packaging News, Ms. Daphne Allen, for a nice summary of the takeaways of the Nurses's Survey and Panel. We focused on the practice of aseptic technique and what helps and hinders the safe and aseptic transfer of medical devices into the sterile field. http://www.pmpnews.com/news/nurses-packaging-preferences-headlined-healthpack Take a look at the PMP News article for key takeaways regarding desired features for sterile medical packaging that facilitate aseptic technique.
Hat tip to Mr. Dave Olson, Dr. O, of Advanced Web of Minnesota, http://www.advancedweb.com/
on his informative article/blog on the development of a better, more effective label specification for the medical device packaging industry. Give this blog a good read, chock full of very informative, actionable content on what is really important in specifying a useful, meaningful label specification for your application.Advanced Web, Dave Olson, Label Blog
docs/IoPP Educ Track-Med Device Packaging High Barrier Pkg KGreene 9-28-11.pdf
Karen K. Greene, Vice President Life Packaging Technology LLC and IoPP Medical Device Packaging Technical Committee, MDPTC Subcommittee Chair, presented recently at IoPP's Education Track at Pack Expo Las Vegas, September 2011.
A process approach to determining how to evaluate and potentially model permeation performance of a high barrier package design.
What test methods and testing techniques bring you actionable results in the most expedient manner. How to successfully partner with the right team of experts for technical support.
Audience members were curious about the global regulatory standards that may apply with medical packaging and what do the regulatory standards provide in the way of barrier evaluation.
Discussion of the pros and cons of modeling and how to act upon the results were discussed with the audience.
The presentation will be broadcast as a Live webinar on Tuesday November 15th 2011 from 1 - 2 PM Central Time so if you missed the conference at Pack Expo you can attend the IoPP webinar. Information sign up is coming soon www.iopp.org
Medical Packaging Design and Compliance
LPT's and Southern California's IoPP.org's --Karen Greene and Jan Gates presented on sterile medical packaging design, development, validation and of course, compliance, at Chicago's Pack Expo, IoPP.org Education Track. The presentation, hosted by IoPP.org was held on November 3, 2010 at McCormick Place in Chicago, Il.
Karen and Jan presented their design perspective based on combined decades of sterile medical packaging experience. References to industry compliance documents, reference documents, testing standards and best demonstrated practices were sprinkled throughout their presentation. Discussion and questions were encouraged and information was exchanged in an informal setting.
The presentation is embedded within the article for your full review.
Michigan State University Health Care Packaging Immersion
Citation from: "Pharmaceutical and Medical Packaging News", on line version--PMP News provides an excellent summary of Michigan State University's Health Care Packaging Immersion Experience developed in conjunction with Oliver-Tolas HealthCare Packaging. The (HcPIE) deployed MSU's Leaning and Assessment Center on the East Lansing, MI campus.
PMP News article except:
In October, Michigan State University (MSU) and Oliver-Tolas Healthcare Packaging debuted their new program, the Healthcare Packaging Immersion Experience (HcPIE). The event brought together healthcare professionals, medical packaging experts from Oliver-Tolas and MSU’s School of Packaging, as well as educators from MSU’s Learning and Assessment Center (LAC), which serves the Colleges of Human Medicine, Nursing, Osteopathic Medicine, and Veterinary Medicine.
Introduced as a pilot program to invited medical device packaging professionals, HcPIE focused on how sterile medical packaging is used in the operating room and in the emergency department. “With regard to medical packaging, the basic challenges facing medical device manufacturers remain fairly constant while the complexity of these challenges increases constantly,” said Jane Severin, PhD, director of technology for Oliver-Tolas Healthcare Packaging. “This venue provides a collaborative approach to problem solving by linking packaging professionals, academia, suppliers, and healthcare practitioners to discuss packaging challenges and solutions.”
Simulated procedures, employing life-like human patient simulators, enabled volunteer healthcare practitioners to open packaged medical devices as they would during actual procedures, revealing how packaging can ease—or hinder—aseptic presentation.
Before the simulations, MSU professors and guest presenters explained theories behind packaging design and aseptic presentation. “Packaging engineers tend to focus on product protection, but they also need to consider the user,” explained Javier de la Fuente, M.S., a doctorial candidate at MSU’s School of Packaging and codirector of Factor IDD, a design consultancy focusing on packaging and product design.
IoPP.org's Medical Device Packaging Technical Committee(MDPTC) is considering ways to leverage this innovative medical packaging design "review" process to advance the end user performance of sterile medical packaging.