Page 243 - Biomedical Engineering and Design Handbook Volume 2, Applications

222 MEDICAL DEVICE DESIGN

7.9.6 Defining the Acceptance Criteria—Package
Integrity Evaluation
Of course, simply subjecting a medical device package to extremes in temperature and humidity con-
ditions for an extended period of time, and then “shaking, rattling, and rolling” it during transporta-
tion simulation and/or subjecting it to environmental extremes, does not indicate the package’s
ability to maintain its sterile barrier.
Package integrity testing was discussed in an earlier part of this chapter. It uses physical test
methods for determining the positive or negative outcome of the package system validation. The
acceptance criteria for a sterile barrier system is generally defined to be the ability to deliver the med-
ical device to the end user in an undamaged and sterile condition. Other detailed acceptance criteria
may apply to the protective packaging and secondary packaging, but the form and parameters may
vary widely. Acceptance criteria could take the form of pass/fail outcomes or be based on a quanti-
tative scoring system or rating of damage levels.

7.9.7 Revalidation of Package Systems
Revalidation of the package system is required when changes have been made to the device, packag-
ing design, packaging materials, and process parameters and/or equipment that will affect the original
validation.

7.9.8 Summary

It is now generally recognized that manufacturers must conduct all three types of tests—physical, trans-
portation simulation, and package integrity—to validate packaging materials and processes. The proto-
col presented here offers the most comprehensive and justifiable methodologies, based on the published
literature, for determining the effectiveness of a medical device package design to maintain its sterile
condition from the point of sterilization to the point of end use and to comply with regulatory standards.

REFERENCES

21 CFR, Part 820, Good Manufacturing Practices for Medical Devices: General, June 1997.
AAMI Technical Information Report (TIR) No. 22-1998, Guidance for ANSI/AAMI/ISO 11607-1997, Packaging
for Terminally Sterilized Medical Devices, Association for the Advancement of Medical Devices and
Instrumentation, Arlington, VA, July 1998.
AAMI TIR 17: 1997, Radiation Sterilization—Material Characterization, Association for the Advancement of
Medical Instrumentation.
AAMI TIR22, Guidance for ANSI/AAMI/ISO 11607, Packaging for Terminally Sterilized Medical Devices—Part 1
and Part 2: 2006, Association for the Advancement of Medical Instrumentation, approved March 20, 2007.
American Society for Testing and Materials, ASTM D 4169, Performance Testing of Shipping Containers and
Systems, ASTM Book of Standards, Vol. 15.09.
ANSI/AAMI/ISO 11607: 1997, Packaging for Terminally Sterilized Medical Devices, Association for the
Advancement of Medical Instrumentation, February 24, 1997.
ANSI/AAMI/ISO 11607-1:2006, Packaging for Terminally Sterilized Medical Devices-Part 1: Requirements for
Materials, Sterile Barrier Systems, and Packaging Systems, American National Standards Institute, 2005.
ANSI/AAMI/ISO 11607-1: 2006, Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements
for Materials, Sterile Barrier Systems, and Packaging Systems, Association for the Advancement of Medical
Instrumentation, Arlington, VA, 2006.
ANSI/AAMI/ISO 11607-2: 2006, Packaging for Terminally Sterilized Medical Devices—Part 2: Validation
Requirements for Forming, Sealing, and Assembly Processes, Association for the Advancement of Medical
Instrumentation, Arlington, VA, 2006.