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This month, we talked with many attendees who stopped by the TSI booth at the American Society of Health-System Pharmacists (ASHP) Summer Meeting. The USP <800> December 1, 2019 compliance date came up often in conversation. Few of the pharmacists we met were confident they would finish work on their 503(a) cleanrooms or 503(b) outsourcing facilities in time for the deadline regarding compounding hazardous drugs.
Top violations revealed
TJC, an inspecting body, delivered a presentation at ASHP that revealed top violations for compounding pharmacies. Two of the top violations were:
- Failing to test engineering controls, and
- Failing to install room pressure monitors.
Clearly, engineering controls are a key component in complying with USP <800> and USP <797>.
The right engineering controls help prevent violations
Complying with USP <800> requires good data from reliable instruments. TSI can help you meet requirements for both 503(a) and 503(b) compliance challenges:
- 503(a) Cleanrooms | TSI PresSura Room Pressure Monitors reliably measure all the key parameters: room pressure differential, temperature, relative humidity and air changes. It does it without concern for drift using a proprietary room pressure sensor. It delivers accurate readings with less maintenance than that required of a traditional pressure transducer. Measurements and alarm status relay to the BAS for simple trending, reporting and remote alarm notifications.
- 503(b) Outsourcing Facilities | TSI Facility Monitoring System seamlessly integrates data from multiple instruments, including particle counters, room pressure sensors, and temperature and humidity sensors, for continuous and periodic monitoring. The FMS helps you easily comply with FDA requirements for environmental monitoring. It immediately warns of excursions to reduce the risk of delivering contaminated drugs to keep patients safe. Many pharmaceutical companies rely on TSI’s FMS in their GMP-validated cleanrooms.