Application Details:
Per USP797 and UPS800, compounding pharmacies are required to keep records of the environmental conditions of the compounding space as well as the temperature within appliances where product is stored. Many compounding pharmacies record this data manually but this can be both time consuming and lead to potential errors.
Customer Problem: Manual data recording in clean rooms prone to errors
Several years ago, a compounding pharmacy was utilizing a manual data logging system for their pressure and temperature readings. This customer was forced to discard thousands of valuable vaccines during the peak of COVID because their employee had forgotten to record the temperature of their storage refrigerators. This resulted in a significant monetary loss as well as reducing the availability of crucial vaccines during a critical period.
Setra Solution:
This customer now utilizes the Setra CEMS continuous monitoring system to automatically record data and alert if any of the conditions go outside their set bounds. Setra offers wireless sensors to measure the temperature within freezers, refrigerators, and incubators, as well as ambient temperature and humidity. The Setra Lite clearly and intuitively displays each rooms pressurization status, making it easy for the staff to understand the room’s condition. The staff now receives real-time text and email alarm notifications and can easily check the status of their space using the CEMS app. CEMS allows this customer to meet all necessary compliances, save time and avoid the potential risk of human error.
Why Setra Won:
Setra CEMS was chosen for its low cost, ease of being retrofit, and ability to provide accurate, reliable data recording that eliminates the risk of human error. The automated system ensures that all critical environmental parameters are continuously monitored and recorded, providing peace of mind and ensuring compliance with regulatory standards.
Setra Strengths:
- Intuitive User Interface
- Low Cost
- Easy to Retrofit
- Automated data recording and historical trends
Setra Products: