Note: This Technical Report has been retired by PDA and is no longer considered to represent current industry best practices. It is available for historical/research purposes only.
This Technical report, the result of a grant to Julius Knapp and Patrick DeLuca, Ph.D., describes the various types of particulate measuring systems and the advantages inherent in their use. It also contains an extensive annotated bibliography on particulate matter.
Available to download
Format: PDF (1 file - 3.15 MB)
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Table of Contents:
Part I - Instrumentation
II. Common Factors
III. Optical Systems
Resistance Modulation Systems (Coulter, etc.)
V. Present Detection Systems
VI. Recent FDA Test Results
VII. Recommended Actions
IX. Future Perspectives
Commercially Available Particulate Measurement Systems for Parenteral Use -
Descriptions and Comments
Appendix II: Coincidence Errors in Particulate
Appendix III: "Ideal" Particulate Measurement
Part II - A Selected Annotated Bibliography on
I. Particle Counting (Size Analysis)
IV. Clinical Effects
Official Limits (Standards)
VI. Visual Inspection
Articles and Letters