Particulate Count Test Procedure

The purpose is to establish that, at critical work locations within clean-rooms, a count of less than 100 particles per cubic foot of air, 0.5 pm in diameter or larger, is maintained. 

It is the responsibility of validation team members to follow the procedures. The quality assurance (QA) manager is responsible for SOP compliance. 

Maximum Allowable Number of Particles (Per Cubic Foot of Air) 

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Pharmacopeial count limits for particulates in parenteral solutions is given in Table 39. The limit depends on the method used for the determination and also on the volume of the sample. Two different procedures for the determination are generally proposed light obscuration particle count test (LO) and microscopic particle count test (M), since neither is applicable to all kinds of samples. 

Spike three (3) sets of vials with NaCl solution. Allow vials to dry and then wash them per the proposed procedure. Baseline data will be established using unwashed, NaCl-spiked vials. Test the washed vials for conductivity (NaCl) and particulate count (WFI). 

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