From MDDI Online
Optimizing Package Design for EtO Sterilization
Published December 2010
An ethylene oxide (EtO) sterilized medical device must be sealed in a carefully designed gas-permeable package that enables the EtO gas to enter. This package must meet a variety of engineering, regulatory, and marketing requirements. In use, a sterile package is opened, the sterile...
Common Mistakes in Medical Sealer Equipment Designs
Published: December 2010
Based on ISO 11607, medical devices delivered in a sterile state should be designed, manufactured, and packed to ensure that they are sterile, under documented storage and transportation...
Qosina PLA tweezer forceps make an Environmentally-friendly alternative to plastic
Published December 2010
Qosina single-use PLA (polylactic acid) tweezer forceps are a biodegradable alternative to plastic kit components. PLA is an allergen free; environmentally-friendly material created from corn with the same physical properties as plastic and can be sterilized using Gamma or ETO....
Humidity and Microbial Penetration in Porous Materials
Published July 2010
Sterile-grade medical papers, such as Ovantex display barrier properties that are used in medical applications. The sterility of most medical device products is of paramount importance. Sterile products are packaged, stored, and distributed in various locations that expose...
Sample Size Selection Using a Margin of Error Approach (*)
Published October 2006
COVER STORY: PACKAGING Manufacturers must employ sample sizes that ensure that packaging systems are safe, meet regulatory requirements, and maintain sterility. Photo courtesy of Beacon Convertors (Saddle Brook, NJ...
The Need for Specificity in Accelerated Aging (*)
Published October 2006
ACCELERATED AGING Materials must provide a microbial barrier over an extended period. Medical device manufacturers invest a great deal of time and money to ensure that their products meet both product performance needs and FDA guidelines....
Common Mistakes in Validating Package Systems (*)
Published May 2006
TESTING A medical device's package plays a key role in safely delivering treatment to patients. It must ensure the integrity of the device from the point of manufacture to the point of final use. In addition, packaging often has a direct function in the application of the treatment...
Updated ISO Packaging Standard Nears Publication
Published April 2006
News Trends John Spitzley said one goal of updating the standard was to make the terminology clearer. Revisions to ISO 11607, “Packaging for Terminally Sterilized Medical Devices,” accomplishes what the original 1997 version failed to do. The new standard...
Applying Pressure-Sensitive Adhesive Labels to Diagnostics
Published March 2006
LABELING Standardized PSA label applicators like this one may offer more flexibility than custom-built applicators. Pressure-sensitive adhesive (PSA) labels are often used in rapid diagnostic devices for point-of-care testing. OEMs who make such devices with PSA...
Next-Generation Tyvek Offers Better Sealing, Printing
Published February 2006
NewsTrends A new grade of Tyvek made its U.S. debut at the Medical Design & Manufacturing West show in January. Tyvek is the most commonly used porous material in medical packaging. Tyvek Asuron from DuPont Medical Packaging (Wilmington, DE) is touted as a successor to the...
Porous Sterile Barrier Integrity Testing: Failure Anomalies (*)
Originally Published MDDI January 2006
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI January 2006 PACKAGING False positives can occur when performing sterile integrity testing. Understanding how to identify them can help...
Bar Code Technology Provides Data Traceability
Originally Published MDDI January 2006
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI January 2006 BAR CODE TECHNOLOGY Before implementing a bar code system, medical device manufacturers should know the basics of bar code...
The Cost of Package Integrity (*)
Originally Published MDDI October 2005
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI October 2005 Packaging Medical device manufacturers often struggle to satisfy packaging requirements. However, examining five key issues can help them avoid potential pitfalls. By...
Originally Published MDDI October 2005
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published MDDI October 2005 Cover Story: Packaging Complex and comprehensive assessments are needed to select the right high-barrier packaging material for devices that are sensitive to...
Don't Be Shortsighted About RFID, Experts Say
Originally Published MDDI May 2005
NEWSTRENDS Don't Be Shortsighted About RFID, Experts Say Erik Swain Are you implementing radio-frequency identification (RFID) because Wal-Mart or another major customer says you have to? If so, you are doing it for the wrong reasons, and you...
There is More to Packaging than Just a Box
Originally Published MDDI March 2005
NEWSTRENDS There is More to Packaging than Just a Box Up-to-date knowledge of materials, testing, distribution methods, and standards is essential for today's medical device packaging engineers, said Jan Gates, senior packaging engineer for...
RFID Tag May Improve Patient Safety
Originally Published MDDI February 2005
NEWSTRENDS Maria Fontanazza SurgiChip Inc.'s surgical body tag uses RFID technology to identify a surgical site on a patient's body. orthopedics sector. An external body tag is the latest application of radio-frequency identification...
Extra Effort: Packaging for Combination Products
Originally Published MDDI January 2005
Packaging Extra Effort: Packaging for Combination Products Producing a suitable package for a combination product requires device companies to understand the regulations, materials, and processes behind drug and biologic packaging...
Sterile Packaging: Sample Sizes and Statistics (*)
Originally Published MDDI October 2004
Cover Story - Packaging Sterile Packaging: Sample Sizes and Statistics Determining appropriate sample sizes for operational qualifications can help manufacturers ensure sterility of medical device packaging. Dennis Gilliland, Laura...
25 Years of Change: Medical Device Labeling
Originally Published MDDI August 2004
Labeling Labeling techniques have undergone many changes since 1979. As a result, the industry has been required to develop new regulations and attitudes toward medical device labels. Dave Olson Dave Olson is vice president of...
Medical Package Testing: It’s Come A Long Way, Baby
Originally Published MDDI August 2004
Package Testing A series of significant events provided the impetus to shift the importance of package testing and package quality much closer to that of the device itself. Stephen Franks Stephen Franks is the executive...
The Role of Heat-Seal Coating in Seal-Peel Medical Packaging
Originally Published MDDI August 2004
Packaging Return to article: Medical Package Testing Selection of a seal-peel packaging construction is influenced by how well the adhesive coating satisfies the basic functional needs of...
1979–2004: Milestones in Medical Device Packaging
Originally Published MDDI August 2004
Packaging The past 25 years have been revolutionary for medical packaging, but it just may be that the best is yet to come. Carl D. Marotta Carl D. Marotta is the president of Tolas Health Care Packaging...
Originally Published MDDI February 2004
EDITOR'S PAGE The reprocessed single-use device debate is going in circles and needs an injection of scientific evidence. The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) stakeholders meeting, held December 3, 2003,...
Medical Packaging: Achieving a Single Global Standard
Originally Published MDDI January 2004
Cover Story A harmonized medical packaging standard will alleviate confusion and provide a single document that will ensure worldwide conformity. Michael H. Scholla Quality packaging systems for sterile medical devices are essential...
Home Alone: Designing Information for Device Users
Originally Published MDDI January 2004
Labeling Understanding how patients interpret instructions can help manufacturers design better labeling and improve customer performance and satisfaction. Patricia A. Patterson In 2002, FDA held a series of meetings to address the...
3-D Packaging for Medical Products
Originally Published MDDI October 2003
MEDICAL Packaging Shape and size are key considerations for manufacturers of high-profile, sterile, disposable devices. John P Merritt Many of the medical devices used in today's market are irregularly shaped, with some...
Harmonization of Medical Packaging Standards Envisione (*)
Originally Published MDDI March 2003
NEWSTRENDS Erik Swain Michael Scholla predicts harmonization ahead. There is a good chance that two major medical packaging standards, ISO 11607 and EN 868, can be at least partly harmonized in the coming years, said a U.S. expert...
Taking the Stress Out of Package Protection
Originally Published MDDI January 2003
PACKAGING An examination of coupled predictive simulations of thermoforming processes and drop-impact loading in package design. Balakrishna Haridas and Clinton A. Haynes Thermoformed packaging is widely used today for the packaging of sterile...
Correlating Peel and Burst Tests for Sterile Medical Device Packages (*)
Originally Published MDDI January 2003
PACKAGING The ability to mathematically relate peel and burst test data could allow results to be taken more rapidly to production and quality control personnel. Rosamari Feliú-Báez, Hugh E. Lockhart, and Gary Burgess Discuss...
Institute of Packaging Professionals Revives Committee
Originally Published MDDI December 2002
NEWS & ANALYSIS Erik Swain After several years of dormancy, the Medical Device Packaging Committee has been revived by The Institute of Packaging Professionals (IoPP; Naper-ville, IL). It plans to begin work on at least four...
Nondestructive Package Tests Lure Device Manufacturers
Originally Published MDDI September 2002
NEWS & ANALYSIS Erik Swain Nondestructive, noncontact ultrasonic imaging technology used for seal integrity testing of trays and pouches. (click to enlarge) Packaging engineers have been intrigued for years by the...
Double-Redundant and Fail-Safe Design for Packaging Machinery
Originally Published MDDI August 2002
COVER STORY When properly applied, double-redundant and fail-safe design methods focus validation practices on machine enhancement and reliability, reducing dependence on operator vigilance and intervention. Ray Johnson As the technology...
Flexibility and Customization Expand Packaging Options
Originally Published MDDI January 2002
PACKAGING Flexibility and Customization Expand Packaging Options Thermoform-fill-seal technology incorporates a wide range of variables that offer manufacturers flexibility in the design and modification of every area in the packaging...
Achieving Efficacy and Sterility in Flexible Packaging
Originally Published MDDI August 2001
Whether the priority lies in the sterilization method or the barrier level, packaging requirements can be easily met with a wide variety of material options. Karen Berger and Dhuanne Dodrill Packaging plays an important role in many...
Adapting Packaging Technology to Meet Device Industry Needs
Published January 2001
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published January 2001 PACKAGING William Leventon Most medical device manufacturers appear to require two things from the packaging industry. First, they need more: more capability, more efficiency,...
Reshaping the Medical Device Packaging Industry
Published: January 2001
Medical Device & Diagnostic Industry Magazine MDDI Article Index The U.S. market for medical device packaging is expected to continue notable levels of growth over the next few years. Forecasts of annual growth rates have ranged from 4 to 5.5% among industry observers—...
A New Family of HF-Weldable Polyolefin Films
Published January 2001
Robert Kelch High-frequency (HF) sealing technology has long been recognized for producing superior weld integrity in a variety of critical applications. As a result, the medical industry has used HF sealing—which is also known as radio-...
How Small Is Small? The Effects of Pinholes on Medical Packaging (*)
Published August 2000
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published August 2000 Learn More! The authors of this article will be presenting their data at Medtec, Oct. 11-13, 2000. Earl T. Hackett, Michael H. Scholla, Stasys Rudys, and John Bletsos Within...
The Science of Particle Counting
Published August 2000
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published August 2000 Robert Drummond According to Earl Hackett, technical marketing associate at DuPont Medical Packaging (Wilmington, DE), it has long been understood that both pinholes and seal...
Breathable TPE Films for Medical Applications
Published: July 2000
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published July 2000 Larry Johnson and Dirk Schultze Thermoplastic elastomer (TPE) films that are permeable to water vapor, or "breathable," are finding increasing use in the medical industry.1...
A Comparison of Heat Seal Coating and Peelable Film Technologies for Medical Packaging
Published: January 2000
Medical Device & Diagnostic Industry Magazine MDDI Article Index Originally Published January 2000 Understanding the relative strengths and weaknesses of different package materials is critical in selecting the best packaging system for a particular device. Selecting packaging...