The Standard Plate Counts test evaluates both total aerobic bacterial and total mold and yeasts. Plate counts can be performed by membrane filtration, pour plates, or spread plate methods. This test is appropriate for all nonsterile products and provides a standardized means of determining the density of heterotrophic bacteria or microbial content of the sample.
Standard Plate Count testing is suitable for pharmaceutical raw materials, nonsterile products such as liquids and powders, transdermal patches, and dietary supplements.
This test is recommended by USP General Chapter 61, USP General Chapter 1227, and the Bacteriological Analytical Manual (BAM). The advantage of using Nelson Labs is our unique validated process for the performance of harmonized testing, as recommended in USP General Chapter 61, including the appropriate media quality control and monitors. Our highly qualified team is also proficient at the plate count validation process, which ensures neutralization and recovery of the microorganisms. The plate count method used by Nelson Labs can be adapted for compliance for both USP and BAM standards.
- USP 1227
- USP 61