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USP 797 Testing

USP 797-Media Fill Test

The Media Fill Test procedure is taken from U.S. Pharmacopeia General Chapter <797>. This testing is used to assess the quality of the aseptic skill of compounding personnel. The media filled containers are incubated for a minimum of 14 days at 35 degrees Celsius. Following incubation, Positive/Negative results are reported for visible turbidity.

USP 797 Testing Services

Sterile compounding procedures require clean facilities, specific training for operators, air quality evaluations, and a sound knowledge of sterilization and stability principles. USP 797 provides guidelines, procedures and compliance requirements for compounding sterile preparations.