Bioburden testing (USP

Contact Plate Method
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Swab Method
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Coliform
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Pseudomonas aeruginosa
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Salmonella spp
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Escherichia coli
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Surface Monitoring
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Active Air Sampling
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Passive Air Sampling
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Kinetic Chromogenic Method
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Kinetic Turbidimetric Method
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Gel Clot Assay
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Direct Inoculation
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Membrane Filtration
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Tests for Specified Organisms
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Bioburden testing (USP

Bioburden testing quantifies the total microbial load present in raw materials, intermediates, and finished products prior to sterilization. Conducted in accordance with USP <1115>, EP 2.6.12, this testing employs membrane filtration and direct inoculation methods. Results from bioburden studies are vital for validating sterilization cycles such as moist heat, dry heat, or filtration and for monitoring contamination risks during production. By controlling bioburden levels, manufacturers safeguard the sterility assurance of the final product.

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