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Barrier Shelf Life for Medical Device Packaging

  
  
  
  
  

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

 

 

 

Sterile Medical Packaging Design and Validation

  
  
  
  
  

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. 

Simulations on Medical Packaging Usability

  
  
  
  
  

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.

 

Medical Packaging Design, IoPP at Pack Expo

  
  
  
  
  

Pack Expo International Learning Center, Medical Packaging Design-Presented by LPT's Karen Greene and Jan Gates, Staff Engineer from Abbott Vascular, Temecula, CA

http://www.linkedin.com/share?viewLink=&url=http%3A%2F%2Flnkd%2Ein%2FyXPKrF&sid=s147335549&uid=5400364583070203904&urlhash=YjuR&redirect=&trk=sae_i_m_sd_val

Cold Chain, ISTA Standard 20 Thermal Performance Standard

  
  
  
  
  

 Cold Chain Update!

ISTA.org Standard 20 Releases  Scheduled September 2010

ISTA Standard 20 and its companion thermal profile, 7E is being released by ISTA.org, targeted for September 2010.  Standard 20 is the first global standard for establishing performance of insulated shipping containers, ISC's.

Standard 20 and thermal profile, 7E, advance the industry need for one global standard that details the minimum thermal and physical testing an ISC should undergo to determine its proof of performance.

Life Packaging Technology LLC will supply certified training and auditing services for Standard 20 for the certification of the cold chain laboratory and laboratory professional.

Sustainable Packaging and the Role of Industry Standards

  
  
  
  
  

29gpr9g Sustainable Packaging

Sustainable packaging design is a process of continuous improvement.  International standards are being developed to help define a framework or metric against which one can measure their attempts at producing a more sustainable packaging design.  This article presents  some background on the sustainability movement and industry's response relative to packaging design.  As sustainable packaging design is more of a process of continuously improving the total life cycle usage of resources while still maintaining effective product protection, this article highlights some new activity in the arena of standards development for sustainable package design.

ISTA 7E Thermal Transport Packaging --LPT selected as Auditors

  
  
  
  
  

At the ISTA.org www.ista.org Transport Packaging Conference, Coronado Springs Resort, FL, the new Thermal Transport Packaging Standard was announced, ISTA 7E.  The ISTA 7E profile is the new standard for thermal transport testing.  The standard includes heat and cold profiles developed from data gathered in real world transport.  All the lane data(thermal) and protocols on how data was gathered will be available for purchase through ISTA.

Amgen http://www.amgen.com/ and their transport packaging team's principals, Don Wilson and Brian Wallin have provided world class leadership in the technology  of thermal transport packaging characterization and validation.  They are technical experts in the field of cold chain transport packaging.

Life Packaging Technology's principals, Karen Greene and Stuart Long have been selected as independent, certified thermal transport auditors.  We are delighted to be identified as key participants in this new standard for thermal transport packaging testing and certification.  The training and auditing roles for LPT's Greene and Long leverage our industry experience of packaging engineering compliance in highly regulated industries as well as our passion for packaging technology and assisting others in bringing successful packaging designs to market. James Cox, PhD, of Cox Technologies, rounds out the global, certified auditing team, bringing a wealth of technical expertise in pharmaceutical consulting and lane data analysis.

 

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Transport Packaging, The ISTA Forum, --Why Attend?

  
  
  
  
  

www.ista.org

This year's Transport Packaging Forum is chuck full of topics relevant to the lifesciences industries.  The presenters are all experts in their field of distribution packaging and most of the authors present original research on distribution dynamics.  An effective distribution simulation protocol is key to successful package design and validation. There are several presentations addressing the latest thinking in sustainability and for those of us interested in temperature sensitive pharmaceuticals and combination products, ISTA reveals an updated testing standard, 7E based on 2 years of field research.  This new ISTA 7E testing standard for thermal performance will give a much needed technical update to the industry relative to evaluating the thermal peformance of your insulated shipper system via a well researched and documented thermal profile.  More to come upon my return from the conference.

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Package Integrity for Medical Device, Food, Chemical

  
  
  
  
  

KKGPackaging

Package Integrity--Co-authored with Mocon, Inc., the leaders in permeation testing and measurement of package integrity for the lifesciences and food industries.

Package Integrity- How to get started?

  
  
  
  
  

MOCON and Life Packaging Technology Webinar

 

 

Package Integrity - How to get started

Join us for a Webinar on January 13

Space is limited.
Reserve your Webinar seat now at:
https://www2.gotomeeting.com/register/198279859

Package integrity is the critical factor for any packaged product.  The maintenance of package integrity is a key determinant of a product's success or failure for its intended use.  Loss of package integrity for the product consumer can range from an annoying or disappointing consumer experience to an unacceptable health or safety issue.  For this session we will consider three packaging stages: design, development and performance.  This presentation highlights key factors any company must identify and expertly manage to assure package integrity.
Presenter: Edward Emerson, MOCON Inc.
Presenter: Karen Greene, Life Packaging Technology LLC

Title:

 

Package Integrity - How to get started

Date:

Wednesday, January 13, 2010

Time:

10:00 AM - 11:00 AM CST

After registering you will receive a confirmation email containing information about joining the Webinar.

 

System Requirements
PC-based attendees
Required: Windows® 2000, XP Home, XP Pro, 2003 Server, Vista

Macintosh®-based attendees
Required: Mac OS® X 10.4 (Tiger®) or newer

 

 

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