Page 226 - Biomedical Engineering and Design Handbook Volume 2, Applications

STERILE MEDICAL DEVICE PACKAGE DEVELOPMENT 205

7.6.6 Conclusion
Package seal strength does not necessarily equate to package integrity. These two attributes of a fin-
ished medical device package are separate considerations in proving the efficacy of the package.
Industry has developed methods for seal strength testing which are used to validate the package
process. Although package seal strength is an important performance attribute, the ultimate accep-
tance of the package is based on its absolute integrity. Some conditioning tests that will subject the
package system to events inherent in its life cycle may be performed prior to integrity testing of the
sterile barrier system. There are several means available for evaluating the integrity of sterile med-
ical device packages. The application of a particular integrity test depends on many factors, includ-
ing the type of package, materials of construction, size, desired sensitivity, and objective of the test.

7.7 PACKAGE PROCESS VALIDATION

This part provides an overview of the package manufacturing and the elements that must be consid-
ered for validating the package sealing and forming process. The ISO 11607 standard states in the
introduction to Part 2:
There should be a documented validation program demonstrating the efficacy and reproducibility of all
sterilization and packaging processes. Along with the sterilization process, some of the packaging oper-
ations that can affect sterile barrier system integrity are forming, sealing, capping or other closure sys-
tems, cutting, and process handling.

7.7.1 Introduction

The product engineering team has developed an exciting new medical device that will improve the
quality of life for many patients. The product has been tested and retested. Regulatory questions con-
cerning the product have been defined and answered. Clinical trials to show that the product per-
forms as intended have been completed. The manufacturing process has proven to be consistent and
is fully documented. However, the challenge of bringing it to the market is just beginning. Many
more questions must be answered before the product can be safely distributed and used by the
patient’s caregiver. The most basic one is, “How will I get the product to the caregiver in the condi-
tion required for safe and proper use?” The most basic answer is “By designing a package system
that will combine with the device to create a total product that performs efficiently, safely, and effec-
tively in the hands of the user.”
At first glance, the issue of developing a package system seems uncomplicated and elementary.
After all, what could be difficult about placing the device into a thermoformed tray, covering it with
®
a Tyvek lid, inserting it into a paperboard carton, and consolidating the cartons into a shipping unit?
In actuality, the process of designing and developing a package for terminally sterilized medical
devices is complex and complicated. This is due to all of the interactions of various processes, equip-
ment, materials, and environments that combine to influence the package design and manufacturing
of the finished product.
For example, the product engineering team has developed the product as a disposable sterile
device that must remain sterile at the point of end use. Therefore, the microbial barrier properties of
the packaging materials, along with the suitability of forming and sealing, are crucial for assuring
package integrity and product safety. So, the product and package materials must be compatible with
the chosen sterilization process. In addition, the product will need to survive the rigors of trans-
portation with its intrinsic hazards of shock, vibration, and environmental conditions. Finally, the
manufacturer must have documented evidence that the performance of the package is not adversely
affected over time (stability).
Unfortunately, the product engineering team was unaware that there are regulations within the
FDA and international community that require a formal package system qualification process and a