Common Mistakes in Validating Package Systems Some common pitfalls can occur during package development and validation. Here�s how to avoid them. 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; for example, it may act as a fixture or a dispenser. Therefore, mechanical damage to a package cannot be tolerated. Device components and packaging systems must combine to create a product that performs efficiently, safely, and effectively in the hands of the user. The packaging process is extremely important as well. Regulatory authorities recognize the critical nature of a sterile barrier system. In fact, they consider packaging an accessory or a component of the medical device, which implies that the package system is nearly as important as the device itself. The package must keep a device sterile throughout all the stresses and hazards generated by the manufacturing, shipping, and storage environments. Ultimately, any device that is labeled as sterile but arrives nonsterile at the point of use can critically compromise patient safety. The design and development of packaging systems have come under scrutiny by both international and domestic regulatory agencies. This scrutiny has placed a great deal of emphasis on standardizing the package development process. Some standardization has come from the International Organization for Standardization in its standard, ISO 11607. Although the existing standards provide guidance, there are some common pitfalls that occur when developing and validating a package system for a terminally sterilized medical device. It is important to know what they are and how to avoid them. The most common defect resulting from subjecting packaged devices to manufacturing, sterilization, handling, and
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Topics of Interest
The ISO 11607 standard is the foremost guidance document for validating packaging for terminally sterilised medical devices. In June 2006, important revisions were made to ISO 11607, which reinforce...
The release of a terminally sterilized medical device or product to the marketplace is the culmination of monumental design and development effort. Efficient, effective and safe usage characteristics...
Patrick J. Nolan
DDL Inc., Eden Prairie, Minnesota
This chapter provides an overview of the process of designing and developing a package system for a medical device. A comprehensive discussion...
Double-Redundant and Fail-Safe Design for Packaging Machinery When properly applied, double-redundant and fail-safe design methods focus validation practices on machine enhancement and reliability,...
Oliver Medical, Grand Rapids, Michigan, USA As the last line of defence between the medical device and bacteria, sterile barrier packaging plays an important role in patient safety. As such, failures...