The quality of compounded medications, and therefore patient safety, is a critical concern for compounding pharmacies. Pharmacies performing compounded sterile preparations (CSPs) must meet specific cleanroom standards like those outlined in USP 797 and USP 800 to ensure sterile conditions and the quality of CSPs are maintained. As such, it is crucial environmental parameters stay within specified limits.
What is Setra CEMS?
Setra’s Continuous Environmental Monitoring System (CEMS) is a cloud-based monitoring software designed to provide digital reporting data visualization, and actionable insights. These actionable insights drive quality control, risk mitigation, and regulatory compliance. Highly adaptable, CEMS can be used for a variety of applications, including:
- Cleanroom Monitoring
- Operating Rooms
- Laboratories
- Isolation and Treatment Rooms
- Vivariums
- Compounding Pharmacies
Setra CEMS for Compounding Pharmacies
Designed to address the most important safety concerns, Setra CEMS eliminates manual data logging and reporting. With easy access to data and data tracking capabilities, users can reduce the risk of human error. Setra CEMS, paired with our sensing hardware or 3rd party sensors, enables users to gain real-time insights into all their locations.
Medications, vaccines, and blood and tissue samples must be stored in controlled environments for safety and FDA compliance. Setra CEMS allows users to seamlessly monitor critical areas and appliances like pharmacy refrigerators, freezers, and blood and tissue banks. Remote monitoring and alerting protocols help prevent damaging environmental fluctuations. Instant feedback ensures faster responses to adverse conditions and mitigates the risk of product sterility.
With Setra CEMS, users can measure and monitor:
- Temperature
- Relative Humidity
- Differential Pressure
- Air Changes Per Hour (ACH)
- Particle Count
Regulatory Compliance
Increased accountability and visibility with automated compliance checks, timestamps, and signatures reduces the difficulty in meeting state and federal requirements for quality control. In addition to being an FDA 21 CFR Part 11 compliant software, Setra CEMS is compliant with:
- NIST
- ISO 9001:2015
- RoHS
- USP 797
- USP 800
