Particulate Matter in Injectables, USP Criteria

The purpose is to provide the USP criteria for the monitoring of liquid-borne particulate matter in injections (large- and small-volume parenterals). 

The apparatus is an electronic, liquid-bome particle-counting system that uses a light-obscuration sensor with a suitable sample feeding device. It is the responsibility of those performing the test to ensure that the operating parameters of the instrumentation are appropriate to the required accuracy and precision of the test result. 

Equipment Climet Cl 1000 particulate analyzer Climet CI1020 batch sampler 

For containers having volumes of less than 25 ml, test a solution pool of ten or more units. Single units of small-volume injections may be tested individually if the individual unit volume is 25 ml or greater. 

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