sterile device packaging

On this episode of SPOT Radio Charlie Webb CPPL speaks with Karen Greene CPPL about the ASTM F-88 medical device pouch testing method. As laboratory owners Charlie Webb CPPL and Karen Greene CPPL provide a fresh optic to the discussion developed from their voice of the customer insight.

Guest Description:

Karen Greene is a tenured packaging professional, A CPPL certified through the institute of packaging professionals. with more than 20 years of experience in the medical device and pharmaceutical packaging industries.

30+ years of professional experience in package engineering. 22 years in medical device and pharmaceutical package engineering and engineering services. Leadership experience, 20+ years.

Specialties: Sterile barrier packaging, structural packaging, films, cushioning, and regulatory compliance for the medical device industry. ISO 11607, ASTM, and ISTA standards. IQ, OQ, and PQ for packaging designs and packaging equipment. DOE experience, test method development, accelerated aging, and pkg design qualifications. Package design and prototyping for sterile medical packaging(sterilization) and all types of structural packaging designs. Thermal package design, development, and validation.

Karen is also the Co-President of the Southern CA Chapter of IoPP and she is the Chair of the Task Group Subcommittee of the IoPP Medical Device Packaging Technical Committee.

You can learn more about her package engineering services which include package design, prototyping, as well as validation consulting by visiting her website.

Contact: www.lifepacklabs.com

Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.

Guest  Description:

Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. 

She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.

Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. 

She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president. 

Contact: Jan Gates 

ph-650.743.5780

packwiseconsulting.com or Adeptpackaging.com

Jan Gates provides valuable insight on how to conform to the latest iteration of the ISO-11607-2019. This lively discussion speaks to potential shortcomings of some device makers in terms of packaging their medical devices. If you are an ISO 13485 medical device manufacturing you will surely benefit from this important discussion.

Guest  Description:

Jan Gates has 35+ experience in package engineering for foods, pharmaceuticals, detergent, and medical devices with a BS in Food Science and MS in Packaging from Michigan State University. Her work includes individual contributions and leading teams for packaging material and systems design and development. The packaging design and development have been completed to meet regulatory, product protection, and customer use requirements; also, included are production optimization, validation, and minimal packaging for sustainability. 

She has previously worked for Bristol Myers Squib, Conagra, Lever Brothers, Dade Behring, and Abbott Vascular. She currently works as an independent consultant in her company, PackWise Consulting, and with Adept Packaging as their VP of Client Solutions and Principal Packaging Engineer.

Jan works with ASTM D10 and F02 committees for rigid/flexible packaging and environmental package testing. 

She is also working as a US representative on various ISO TC 122 committees for packaging tests, vocabulary, labeling, and product shipment. She was a task group lead with AMMI on a US guidance document for compliance with ISO 11607-1/-2 (packaging for terminally sterilized medical devices); the guidance document was converted to ISO/TS 16775. She is on the IoPP (Institute of Packaging Professionals) HealthPack Advisory board, IoPP Medical Device Packaging Technical Committee and is the Southern California IoPP Co-president. 

Contact: Jan Gates 

ph-650.743.5780

packwiseconsulting.com or Adeptpackaging.com

In this episode, Karen Greene CPP speaks on the verity of medical device pouch testing methods. Charlie Webb CPP gains clarity on the ASTM F-88 test method and learns how her company (life pack labs) approaches medical device package testing.


Guest  Description:

Karen Greene is a tenured packaging professional, A CPP certified through the institute of packaging professionals. with more than 20 years of experience in the medical device and pharmaceutical packaging industries.

The first seven years of her 30+ year career were in the food packaging industry where she held professional positions with Nabisco Brands and Thomas J. Lipton Company.

Her medical device and pharmaceutical packaging experience included leadership positions with IMED Corporation (now Cardinal Health), Edwards Lifesciences, and Allergan.

She has led teams of individuals responsible for medical device and pharmaceutical package development, validation, and production implementation. She has also led teams responsible for documentation, configuration management, and label development and control.

Karen has published several articles in her area of specialization, (the packaging of terminally sterilized medical devices) and she presents frequently at industry conferences such as Medical Design and Manufacturing conference.

Karen is also the Co-President of the Southern CA Chapter of IoPP and she is the Chair of the Task Group Subcommittee of the IoPP Medical Device Packaging Technical Committee.

You can learn more about her package engineering services that include package design, prototyping, as well as validation consulting by visiting her website.

www.lifepacklabs.com

Charlie discusses the "lifecycle approach" to medical device packaging. Some medical device manufacturers do not continue to watch the arc of their sterile packaging validation plan and failures, therefore, happen as a result. Validation is a living process that needs constant monitoring at all levels to thwart potential packaging failures that could result in a sterility loss of the device. Also on this episode guest Rod Jennings a nuclear power plant field engineer discusses human systems like checklists and acronyms. These systems help guide critical process to better control expected outcomes.