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USP797 Current Regulations
Microbial air and surface sampling is essential for maintaining environmental quality in sterile compounding areas. The program includes viable impact volumetric airborne particulate sampling and surface sampling to detect contamination, assess cleaning effectiveness, and ensure proper personnel practices.
Air Sampling
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Conducted in all classified areas (ISO Class 5 PEC, ISO Class 7 and 8 rooms) during dynamic operating conditions.
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Minimum frequency: Every 6 months for Category 1 and 2 CSPs; monthly for Category 3 CSPs.
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Use impaction air samplers with general microbial growth media (e.g., TSA).
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Samples are incubated at 30°–35° for 48 hours and 20°–25° for 5 additional days.
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Action levels: ISO Class 5 (1 cfu/m³), ISO Class 7 (10 cfu/m³), ISO Class 8 (100 cfu/m³).
Surface Sampling
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Conducted monthly for Category 1 and 2 CSPs; weekly for Category 3 CSPs.
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Samples taken from equipment, work areas, and frequently touched surfaces.
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Media devices contain microbial growth media with neutralizing additives (e.g., lecithin, polysorbate 80).
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Incubation follows the same temperature and duration as air sampling.
Action levels: ISO Class 5 (3 cfu/device), ISO Class 7 (5 cfu/device), ISO Class 8 (50 cfu/device).
Corrective Actions & Documentation
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Investigate and address contamination exceeding action levels.
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Identify microorganisms to the genus level if necessary.
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Implement process improvements, personnel training, or equipment repairs.
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Sampling procedures, results, and corrective actions must be documented and reviewed regularly.