Abstract
A procedure has been developed to verify the particle counter lower counting limit (LCL) specified by the manufacturer for a laser particle counter (LPC). The procedure uses existing commercially available products to confirm an LPC lower size counting limit. The procedure involves the use of NBS traceable polystyrene latex (PSL) particles and an electrostatic classifier to generate highly monodisperse (single size) particles near the lower size limit of the LPC. A condensation nucleus counter (CNC) is used as a standard for particle concentration, since its lower size limit is far below the LPC’s. By comparing the LPC concentration with that of the CNC, the lower counting limit of the LPC can be verified. This is especially well suited for certifying that pharmaceutical and electronics clean room counters are operating according to manufacturer specifications. The method is unique in that it specifies the LCL as an efficiency curve rather than as a single efficiency point.
- Received October 5, 1988.
- Accepted March 1, 1989.
- Copyright © Parenteral Drug Association. All rights reserved.
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