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Knowledge Center

Articles and Links

Integrity Testing Methods For Sterile Barrier Systems | Published 10/2018, MD+DI

IMUA Podcast with Karen Greene at LPL I 5/3/16

Are You Skipping This Essential Medical Product Development Step? Find Out From Karen Greene

 

CanadianPackaging I Package Development and Testing Company Formed I 9/9/14

Life Pack Labs to help improve speed-to-market, costs for pharmaceuticals and medical devices.

 

Downloadable Resources

Life Science Packaging Materials Playbook I Healthcare Packaging
LPL's President Karen Greene provided her expert knowledge to Healthcare Packaging for this playbook
 
Written specifically with life sciences packaging professionals in mind. The Life Science Packaging Materials Playbook reveals the connection and interaction between the product and the material in which it’s packaged.
Webinar I Medical Device Packaging - Sample Size & Statistical Rationale
Download the webinar slides from the live webinar given April 28, 2016
 
EU MDR - 10 Things Packaging Engineers Should Know I Network Partners
Download the e-book explaining what you should know about the EU Medical Device Regulation
 
The EU Medical Device Regulation (MDR) was approved by the European Parliament on April 5, 2017, and, following its formal adoption, was published in the Official Journal of the EU on May 26, 2017. Here are 10 things you should know.
 
Presentation I Managing Unique Temperature Control Requirements
Download the slides from this presentation given by Karen Greene, CPP at ISTA TEMP Pack Forum 2018, March 22, 2018
 
Article I 3 Testing Tips for Medical Device Packages
Download this article written by Karen Greene, CPP at Life Pack Labs
 
This article will give you key tips for ensuring that your medical package system is evaluated and ultimately validated with the most appropriate, relevant testing protocols for validation of sterile barrier integrity and overall package and product safety and efficacy.

Useful Industry Resources

Medical Device Manufacturers Association (MDMA)

MDMA is a national trade association based in Washington, D.C. that represents nearly 130 independent manufacturers of medical devices, diagnostic products and health care information systems. MDMA seeks to improve the quality of patient care by encouraging the development of new medical technology and fostering the availability of beneficial innovative products

Life Science Packaging Materials Playbook

Download this new free e-Book, written specifically with life sciences packaging professionals in mind. The Life Science Packaging Materials Playbook reveals the connection and interaction between the product and the material in which it’s packaged.

PackageIntegrity.com Packaging Industry Resource

 

Packageintegrity.com is an online collaborative resource center for packaging professionals, hosting objective advice, new technologies, and information. Packageintegrity.com brings colleagues in the packaging world together to discuss the latest and greatest technical developments within the packaging industry.

International Safe Transit Association

 

International Safe Transit Association (ISTA) is an organization focused on the specific concerns of transport packaging. ISTA is the leading industry developer of testing protocols and design standards that define how packages should perform to ensure the protection of their contents during the ever changing risks of the global distribution environment. 

USP - US Pharmacopeia

 

At USP everything they do is in service of their mission to help protect and improve the health of people around the world. From the standards we create to the partnerships we foster, we continually work to build and reinforce a foundation that draws us closer to a world where everyone can be confident of quality in health and healthcare.

Flexible Packaging Association​

The Flexible Packaging Association has served as the voice of the flexible packaging industry since 1950. FPA’s goals are connecting, advancing and leading the flexible packaging industry. FPA members are manufacturers of flexible packaging sold to users or distributors for packaging purposes, and material or equipment suppliers to the industry.

ASTM International

 

ASTM International is a globally recognized leader in the development and delivery of voluntary consensus standards. Today, over 12,000 ASTM standards are used around the world to improve product quality, enhance health and safety, strengthen market access and trade, and build consumer confidence.

 

Beyond standards development, ASTM offers certification and declaration through a subsidiary, the Safety Equipment Institute, as well as technical training programs and proficiency testing.

 

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