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Package Integrity—How to get started?

Ed Emerson
BUSINESS DEVELOPMENT MANAGER
MOCON, INC.

Karen Greene
VICE PRESIDENT
LIFE PACKAGING TECHNOLOGY, LLC

MOCON and Life Packaging Technology

www.lifepackagingtechnology.com

Webinar Outline
 What is package integrity?
 Package integrity tool kit
 Question and Answer

What is Package Integrity?

How well a package protects the product
over a defined period from physical,
microbiological or chemical challenges

(ASTM F-17 standard terminology)

Ultimately, package design determines a
product’s success for its intended use
– Maintains safety and efficacy
– Ensures positive
consumer experience

Package Integrity Tool Kit
8 Tools for Success
– To help with these packaging stages:
• Design
• Development
• Performance

Design Phase: Tool #1
DEFINE PRODUCT PROTECTION REQUIREMENTS
 Identify product sensitivities and
Regulatory requirements –Appendix
– Foods
– Cosmetics
– Drugs, Devices, Biologics
– Electronics
– Consumer Products

DEFINE PRODUCT PROTECTION REQUIREMENTS
 Other Worldwide Guidance
Shipping Temperature Sensitive Goods

DEFINE PACKAGING AND PROCESSING
 What are our
capabilities vs. requirements?

IDENTIFY DISTRIBUTION AND STORAGE
 Define all environmental hazards:
– Global and Regional Distribution
– Logistics Support
– Cargo Modes (Truck, rail, sea, air)
– Temperature Controlled
(Refrigeration)
– Shipping unit
(Palletized, Gaylord,
Single Parcel)

RISK ASSESSMENT
 Criticality of loss of integrity
– Product sensitivities
– Design inputs
– Manufacturing and processing inputs
– Distribution and storage
• Tools 1 - 3

Development Phase: Tool #5
PROTOTYPE PACKAGE DESIGN
 Considering tools 1-4
– Product sensitivities
– Regulatory requirements
– Packaging and processing
– Storage and distribution
– Risk assessment

CHARACTERIZE PACKAGE INTEGRITY
 Evaluate protection gaps
Laboratory methodologies
– Air Gases, Vacuum or Moisture
– Physical Seals or Leaks
• Sterility
– Fragility

REFINE PACKAGE DESIGN
 Based on:
– prototype integrity characterization
– risk assessment
– regulatory requirements

Performance Phase: Tool #8
VERIFY PACKAGE INTEGRITY
 Precise laboratory measurement
– Package leak rate
– Package transmission rate
– Headspace analysis
– Flavor and Odor detection
– Fragility testing

Performance Phase: Tool #8
VERIFY PACKAGE PERFORMANCE

Summary
 Focus on understanding your product integrity
requirements
 Consider and Manage
– Design
– Development
– Performance
 8 Tools:
#1 Identify Integrity requirements and regulations
#2 Define Processing inputs
#3 Define Distribution and storage factors
#4 Perform Risk assessment
#5 Prototype package design
#6 Characterize integrity
#7 Refine package design
#8 Verify integrity performance


Questions??
webinars@mocon.com

Presenters:
edemerson@mocon.com
karen@lifepacktech.com

Next Month’s Webinar…

FEBRUARY 10TH
“High Temperature
Permeation Testing”


Thank You

www.lifepackagingtechnology.com

Appendix
Helpful Links:
• Food and Cosmetic Compliance Program Manual
http://tinyurl.com/ygf7973
• Current Good Manufacturing Practices for Food
http://tinyurl.com/yh32fkw
• Hazard Analysis Critical Control Points http://tinyurl.com/n4m2dr
• Drugs, CDER http://tinyurl.com/yzhkxv3
• Biologics, CBER http://tinyurl.com/yfpdmew
• Devices, CDRH http://tinyurl.com/lptacx
• Combination Products Office http://tinyurl.com/ygnd9cg
• Bureau Veritas, electronics safety http://tinyurl.com/yan3tbv
• Cosmetics labeling and security http://tiny.cc/e74hx
• U.S. Consumer Product Safety Commission http://tiny.cc/dPMte

Appendix, Continued
Regulatory requirements—Global Shipping
• World Health Organization(WHO)—International packaging and shipping of
vaccines
• WHO—Good Distribution Practices for Pharmaceutical Products
• USP—General Chapter 1079, Good Storage and Shipping Practices
• Canada– Guide 0069--Guidelines for Temperature Control of Drug Products
during Storage and Transportation
• EU– 94/C63/03--Guidelines on Good Distribution Practice of Medicinal Products
for Human Use
• Irish Medicines Board—Guide to Control and Monitoring of Storage and
Transportation
• Australia--- Code of Good Wholesaling Practice for Therapeutic Goods for
Human Use
• US PDA—Technical Report No. 39, Cold Chain Guidance for Medicinal Product:
Maintaining the quality of temperature sensitive medicinal products through the
transportation environment.
• IATA(International Air Transportation Assoc) trade body, represents
airlines, cargo agents and passengers—July 2009--9th Edition-The Perishable Cargo
Regulations Manual—Management of time & temp sensitive goods, chapter 17.

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Package Integrity How To Get Started Webinar 13 Jan2010 Final No Notes

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Package Integrity How To Get Started Webinar 13 Jan2010 Final No Notes