Monitoring Compounding Pharmacies with Setra CEMS

复合药物的质量以及患者安全是复合药房的一个关键问题。执行复合无菌制剂(CSPs)的药房必须满足特定的洁净室标准，如USP 797和USP 800中概述的标准，以确保无菌条件和CSPs的质量得以保持。因此，环境参数保持在规定的范围内是至关重要的。

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 CEMSeliminates 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 3^rdparty 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 anFDA 21 CFR Part 11 compliant software, Setra CEMS is compliant with:

• NIST
• ISO 9001:2015
• RoHS
• USP 797
• USP 800