Abstract
To facilitate more rapid application of automated particulate inspection systems, biophysical foundations for the industry standard manual inspection have been traced. This theoretical support for the probabilistic inspection model described by Knapp and Kushner formally links an applied analysis to its theoretical roots. Ethical obligations and clinical requirements for parenteral products are reviewed. It is concluded that the small sample quantities employed in destructive testing of particulate contamination in production batches leads to results that are too variable to ensure adequate process control.
- Received December 10, 1981.
- Accepted January 6, 1981.
- Copyright © Parenteral Drug Association. All rights reserved.
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