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USP <797> Sampling USP <797> refers to chapter 797 "Pharmaceutical Compounding - Sterile Preparations," in the USP National Formulary. It sets practice standards to help ensure that compounded sterile preparations are of high quality. USP <797> describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.
A few guidelines when USP <797> sampling:
Bioaerosol sampling with the Surface to Air Sampler (SAS) - Impaction - Collection of air should be on a trypticase soy agar (TSA) plate for bacteria and/or inhibitory mold agar (IMA) plate for fungi.
Recommended testing time is 5-10 minutes at 100 to 180 liters of air/minute (total volume recommended is 1000 liters of air).
Contact Rodac Agar Plates are used for surface sampling - TSA plate (65x15 mm) with Lecithin and Polysorbate 80 for bacteria and/or Sabouraud dextrose agar for fungi.
DAB plates are used for gloved fingertips of pharmacy personnel. TSA plates with Lecithin and Polysorbate 80 for bacteria and/or Sabouraud dextrose agar for fungi.
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Micro-Solutions, Inc. USP <797> reports are in easy-to-read format
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remediation. Click here to view a sample USP <797> report.
Ship or deliver your samples along with your completed Chain of Custody/Laboratory Test Request Form to:
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