PDA Technical Report No. 9, (TR 9) Review of Commercially Available Particulate Measurement Systems (single user digital version)

Jan 1988
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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.

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Table of Contents

Table of Contents:

Part I - Instrumentation
I. Introduction
II. Common Factors
III. Optical Systems
IV. Resistance Modulation Systems (Coulter, etc.)
V. Present Detection Systems
VI. Recent FDA Test Results
VII. Recommended Actions
VIII. Longer Term Actions
IX. Future Perspectives
X. Notes
Appendix I: Commercially Available Particulate Measurement Systems for Parenteral Use - Descriptions and Comments
Appendix II: Coincidence Errors in Particulate Counters
Appendix III: "Ideal" Particulate Measurement System

Part II - A Selected Annotated Bibliography on Particulate Matter
I. Particle Counting (Size Analysis)
II. Methods Evaluation
III. Identification
IV. Clinical Effects
V. Official Limits (Standards)
VI. Visual Inspection
VII. Unpublished Articles and Letters