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.