HACCP and its implications for sterile medical device packaging.

Strength and integrity are the two attributes that must be monitored at the critical point. Strength can effectively be monitored by operating the sealing equipment within the validated control limits. Integrity is another matter entirely. Integrity failures are often random occurrences that must be visible to the trained operator. Yet, this is not true in every instance. Use of precise testing equipment, which exceeds the capabilities of visual testing, is a more effective way to manage the critical control point. New technology to more effectively test the attributes of seal and package integrity at the critical control point is currently under development. Data on its capabilities will shortly be available.