Healthcare Facility Compliance 12 items
Sterile Compounding Environmental Monitoring Audit (USP 797)
Audit of viable and non-viable environmental monitoring, certification, and cleanroom controls for a sterile compounding pharmacy under USP General Chapter 797.
USP General Chapter 797USP 1116State Board of Pharmacy
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Certification & Facility Controls
- Are primary and secondary engineering controls certified at least every 6 months and after any relocation? *
- Are ISO classifications documented (ISO 5 PEC, ISO 7 buffer room, ISO 8 ante-room) as applicable? *
- Are room pressure differentials or airflow velocities monitored and within specification? *
Viable Air & Surface Sampling
- Is viable air sampling performed in all classified areas at least every 6 months using an impaction sampler? *
- Is surface sampling of classified areas performed at least monthly? *
- Are action levels defined and is any organism recovered above action level identified to genus? *
Non-Viable Monitoring & Cleaning
- Are total airborne particle counts measured under dynamic conditions at required intervals? *
- Are cleaning and disinfection performed and documented per required frequencies, including a monthly sporicidal agent? *
- Is a corrective action plan documented and implemented when monitoring results exceed action levels? *
Personnel Monitoring
- Is gloved fingertip and thumb sampling performed after garbing and after media-fill testing at required frequencies? *
- Is media-fill testing completed successfully before compounding and at required intervals? *
- Are personnel garbing and hand hygiene competencies observed and documented? *
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