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Generate & Play Hailuo AI video：Microbial Enumeration Tests Detailed Overview of USP Chapter <61>: 1.1 Purpose and Scope USP Chapter <61> provides validated methods to quantify total aerobic microorganisms (TAMC) and total yeasts and molds (TYMC) in non-sterile pharmaceutical, cosmetic, and dietary supplement products. The tests ensure products comply with microbial quality standards, minimizing contamination risks to patients. 1.2 Applications: Oral solids/liquids, topical creams, herbal extracts, raw materials, and medical devices not requiring sterility. Exclusions: Sterile products (covered under USP <71> Sterility Tests) or products with inherent antimicrobial properties requiring specialized neutralization. 1.3 Test Methods: Detailed Protocols 1.3.1 Membrane Filtration Use Case: Ideal for aqueous liquids (e.g., syrups, injectables) or solvents where microbes may be sparse. Procedure: 1. Pass a specified volume (typically 10–100 mL) through a sterile 0.45-µm membrane filter. 2. Rinse the filter with buffered saline-peptone solution (e.g., pH 7.0) to remove inhibitory residues. 3. Transfer the filter to agar plates (SCDA for TAMC, SDA for TYMC). Advantages: Concentrates microbes from large volumes; minimizes product interference. 1.3.2 Pour Plate Method - Use Case: Suitable for semi-solid or soluble products (e.g., ointments, powders). - Procedure: 1. Mix 1 mL (or 1 g homogenized) sample with 15–20 mL liquefied agar (cooled to ~45°C). 2. Pour into a sterile Petri dish, solidify, and incubate. 3. Colonies grow within the agar and on the surface. Limitations: Not ideal for heat-sensitive microbes due to warm agar. 1.3.3 Spread Plate Method - Use Case: Low-microbial-load samples or oxygen-sensitive organisms. - Procedure: 1. Spread 0.1–0.5 mL of sample evenly on pre-poured agar surfaces. 2. Incubate without inversion to maintain surface moisture. - Advantages: Prevents thermal shock to microbes; ideal for strict aerobic conditions.
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The video provides a detailed overview of USP Chapter <61>, focusing on microbial enumeration methods to ensure product quality and safety.
