Defining Test Practices
By David Vaczek, Senior Editor
Pharmaceutical and Medical Packaging News
An ASTM standard for climatic stress testing of small parcels is approved.
ASTM committees have recently focused on testing packages’ ability to withstand shipping environmental hazards, and evaluating new methods for testing sterile barrier system integrity.
After recent completion of balloting in ASTM International Committee F02 on Flexible Barrier Packaging, ASTM’s committee on standards approved in December ASTM F 2825-10, Standard Practice For Climatic Stressing of Packaging Systems For Single Parcel Delivery.
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Packaging Sustainability for the Life Sciences Industry
Sustainability has become mainstream, and European standards may influence the development of global standards. But there could be some unintended consequences to sustainability that medical device manufacturers should be wary of when redesigning packaging.
By Patrick Nolan, DDL President
Pharmaceutical and Medical Packaging News
Sustainability has become mainstream, and European standards may influence the development of global standards. But there could be some unintended consequences to sustainability that medical device manufacturers should be wary of when redesigning packaging.
For packaging professionals, designing the optimal package has always been the objective. For years the packaging industry has been obligated to provide “sustainable” packaging through state and local legislation (Green Laws, Packaging Waste Directives, ‘Reduce/Reuse/Recycle initiatives); economics (increased margins on products and lower product costs to the consumer); reduced damage claims (engineering, design, testing); and new technologies. Packaging engineers have been designing packaging with these criteria in mind since the first packaging engineer graduated from Michigan State University. The first Earth Day heightened the challenge for packaging engineers. More recently, the rapid industrial growth of countries such as India and China has heightened the awareness of the environmental impact of industrialization.
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Package Performance Testing Conundrum: Solved!
Risk to product efficacy will dictate choices in shipping simulation testing.
By Pat Nolan, Scott Levy & Karen Greene
DDL, Inc.
The purpose of a distribution or transportation simulation test is to evaluate the performance of the complete packaging system. However, such testing is a conditioning element, as there is no specific or variable result derived from these tests. It simply subjects the test specimen to dynamic hazards (e.g., shock, vibration, or compression) inherent to the transport and distribution of products to the end-user.
The testing performed on the interior packaging after the ‘conditioning’ identifies whether the package system passes or fails. The pass-fail criterion (e.g., package leakage, loss of sterility, product breakage, etc.) for the package system design performance validation must be established prior to testing.
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Biopolymers Hold Potential
By Daphne Allen, Editor in Chief
Like forward-thinking medical device manufacturers these days, Edwards Lifesciences has launched an internal initiative to lessen its impact on the environment. As a result, Project Green, the company’s effort, has its packaging leader exploring biopolymers. Don Krebs, CPP, senior packaging engineer, global packaging operations, will be presenting “Challenges of Implementing Biopolymer Packaging Material in the Medical Device Industry” at the upcoming Medical Design & Manufacturing West 2010 in Anaheim, CA, held February 8-11.
“Project Green involves benchmarking our operations and then measuring our achievements,” explains Krebs. “For instance, our buildings are measured for their energy consumption, and then we have contests to see which one can reduce its energy use the most. As a result, energy consumption per unit cost has been reduced by 20% over the past 5 years, resulting in a savings of up to $1,000,000 globally on a year-to-year basis. We are also measuring paper use. Paper consumption has decreased by more than 20% with an emphasis on purchasing higher postconsumer-content paper. Edwards in the future is focusing more on improving its supplier and customer environmental initiatives, including a strong emphasis on packaging source reduction and reducing environmentally unfriendly packaging materials.”
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Compliance Partners
By Editor
Pharmaceutical and Medical Packaging News
Outsourcing to meet the standards set in ISO 11607:2006 has valid benefits, according to contract packaging firms. Compliance provisions require packagers to have the most current standards at hand and to incorporate them into their process. When such monitoring and execution takes valuable resources away from a company’s primary functions, outsourcing might effectively help to meet compliance needs.
ISO 11607:2006, part 1, outlines basic requirements for terminally sterilized medical device packaging. ISO 11607:2006, part 2, describes validation requirements for each step of packaging. Each contains extensive instructions that took more than five years to assemble and approve.
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Take a Team Approach to ISO 11607
By Daphne Allen, Editor in Chief
Pharmaceutical and Medical Packaging News
The revised ISO 11607 standard—formally known as EN/ISO 11607:2006, Parts 1 and 2—offers medical device manufacturers (MDMs) further guidance on sterile packaging. But that is all it is—guidance. MDMs will have to make several decisions on their own.
“There are a lot of areas for interpretation in ISO 11607,” says Randy Troutman, technical director of Oliver Medical (Grand Rapids, MI). “The standard tells you what you have to do to comply, not how to do it.”
Troutman will be leading a daylong packaging conference at the upcoming Medical Design & Manufacturing East 2008 in New York City June 2. The standard will be a key topic throughout speaker presentations.
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Alternative Test Methods Seek Recognition
ASTM focuses on porous packaging, distribution, and accelerated aging.
By David Vaczek, Senior Editor
Pharmaceutical and Medical Packaging News
At ASTM’s October 2006 meeting, ASTM subcommittees approved changes to standards covering tests for distribution simulation and package accelerated aging, and balloted physical testing methods for measuring the integrity of porous packages and materials.
“To date, there is no commercially available low-cost test for measuring porous package integrity. Manufacturers have come out with $100,000 machines that [most] companies can’t afford. Bubble tests are the best we have, but they are nonquantitative and cumbersome,” says Jim Zynda, sales manager, Test-A-Pack, Carleton Technologies (Orchard Park, NY).
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ISO 11607 Changes
DDL has launched a service that e-mails alerts on standards changes. Professionals who sign up on DDL’s Web site can request updates on specific standards or from designated associations. Standards bodies covered include ASTM, ISO, AAMI, and IEC.
PMP News editors recently toured DDL West (Costa Mesa, CA), taking in its full-service lab for strength and integrity testing as well as aging and distribution simulation. Karen Greene, technical director, told PMP News that the newly revised ISO 11607-1 and 11607-2:2006 more clearly define stability testing (e.g., accelerated aging and real-time aging) and performance testing (e.g., environmental and distribution testing) as separate entities, evaluating different aspects of the sterile barrier package.
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Complying with EU Packaging Regulations Using ASTM International Standards
The world would be chaotic were it not for standards that allow the industrial community to simplify commerce. Standards promulgate a common language that promotes the flow of goods between buyer and seller and aids the common man by improving safety and safeguarding health. Some simple examples are; the use of nuts and bolts in both the metric or SI systems; a 92 octane gasoline that meets specific combustion ‘standards’ and state and federal regulations require that gasoline meet these standards so the consumer knows what he/she is pumping into their gas tanks; plugs (e.g. serial, parallel, RF) for connecting peripheral components to computers are all uniform worldwide for every type, make, and manufacturer of computers; medical devices are tested using standardized test methods so that performance specifications can be developed, and these same tests can be used to test the efficacy of similar or competing devices. Standards create order where there is disorder.
In short, “buildings stand, planes fly, paint adheres, chairs support, and clothes fit because each is made to order by technical standards for materials, design, and performance”. |
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