Page 219 - Biomedical Engineering and Design Handbook Volume 2, Applications

198 MEDICAL DEVICE DESIGN

Corrugated Fiberboard Boxes. A corrugated fiberboard box is used to transport the medical
device through the distribution environment and to its ultimate user. This package may be known as
the shipping container, shipper, shipping box, transport package, or other name that denotes its pur-
pose as the final package to be offered for shipment. This package may contain only primary pack-
age types, or single or multiple secondary packages containing primary packages. In this case the
package system may be considered to have a primary, secondary, and tertiary package.
Most shippers are made from a material known as corrugated fiberboard. The paper-based mater-
ial consists of a corrugated medium sandwiched between two kraft paper faces. It is characterized by
the thickness and spacing of the medium (fluting), the weight of the facing layers, and the quality of
the paper used. Most medical devices are transported in a grade and style of shipper known as a single
wall, C-flute, regular slotted container (RSC).

7.6 COMMON TESTING METHODS

This part details some of the testing methods used and accepted within the medical device industry for
characterizing the performance of the package. These methods will be used to validate the packaging
processes and to establish performance specifications for continuous monitoring of quality. An ASTM
international standard, entitled F2097-07 “Standard Guide for Design and Evaluation of Primary
Flexible Packaging for Medical Products,” provides a compendium of test methods. Specific individ-
ual test methods must be selected based on the pertinent characteristics of the specific product to be
packaged and the purpose for testing, research and development, or compliance. Not all test methods
will be applicable.

7.6.1 Introduction
The package for a medical device plays a key role in safely delivering specialized treatment to the
patient for which the device was designed and developed. It must ensure the efficacy of the device
from the point of manufacture to the point of final use. Most single-use terminally sterilized medical
devices must be delivered with a very high confidence that the device has remained in a sterile con-
dition throughout its storage, handling, and transport environment. In addition, packaging may have
a direct function in the application of the treatment, as it may act as a fixture or dispenser to the
physician. Thus, mechanical damage to the package may not be tolerated. The design and develop-
ment of the packaging system has come under closer and closer scrutiny by both the international
and domestic regulatory agencies. This scrutiny has placed a great deal of emphasis on standardiz-
ing the package-development process. Some standardization of the packaging process has come in
the form of the international standard entitled ISO 11607, “Packaging for Terminally Sterilized
Medical Devices.” Annex B of the ISO 11607 standard provides “informative” knowledge on stan-
dardized test methods and procedures that may be used to demonstrate compliance with the require-
ments of Part 1 ISO 11607. This section specifically presents the current consensus thinking and
some industry test methods available for evaluating the integrity and strength of sterile barrier systems
and package system performance.

7.6.2 Package Integrity versus Package Strength

First, there seems to be some confusion within the medical device industry regarding the strength
versus the integrity of a package. Package strength concerns the force required to separate two com-
ponents of the package. It could be the force to separate two flexible components of a pouch or a
flexible lid and a thermoform tray. These forces may be measured in pounds per inch width, as in
the seal/peel test; or in pounds per square inch, as in the burst test method. Alone, these tests of pack-
age strength values do not necessarily prove the integrity of the entire package. For example, since