Setra CEMS™ Applications

Real-Time Environmental Monitoring for Healthcare and Life Sciences

Comprehensive Wireless Monitoring for Critical Environments

Setra CEMS is engineered to safeguard the integrity of temperature-sensitive assets across healthcare, pharmaceutical, and life science industries. The platform includes Setra CEMS Connect, a multi-parameter monitoring solution for pressure, temperature, humidity, and more, and Setra CEMS Diligence, a wireless temperature monitoring system ideal for cold storage and refrigeration. Together, these solutions deliver automated, real-time monitoring, centralized data access, and instant alerts—helping facilities meet stringent regulatory standards, reduce human error, and protect valuable inventory. Whether you're managing a compounding pharmacy, vaccine storage, laboratory, or manufacturing site, Setra CEMS ensures peace of mind and operational efficiency through audit-ready reporting and scalable integration.

Drive Compliance

Ensure the effectiveness of critical control procedures and protocols by eliminating human error and incorrect data, with secure recording on a fully auditable platform.

Centralized Reporting

Access and consolidate data from multiple departments and sites into a central, multi-user reporting platform for management on the move.

Budget Conscious

Maximize your budget by investing in automated monitoring, reducing the need to replenish valuable stock that may otherwise spoil due to temperature fluctuations.

Efficiency & Optimization

Optimize key resources and increase productivity by automating routine temperature recording tasks.

Reduce Waste

Automated 24/7 monitoring allows proactive management of your temperature-controlled assets, mitigating product loss.

Accredited Calibration

Setra has ISO 17025 & UKAS accredited calibration laboratories, and we can bring these services to you with our onsite engineers.

Biopharma cleanroom with stainless steel processing tanks and precision monitoring systems

BioPharma

Environmental Control for Biopharmaceutical Products

In the biopharma industry, maintaining strict environmental conditions is critical for ensuring the safety and efficacy of products. Regulatory bodies such as the FDA impose rigorous requirements for temperature control and monitoring. At Setra, we provide advanced wireless temperature monitoring systems that ensure compliance and operational efficiency in biopharmaceutical environments.
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Our automated systems continuously monitor and log temperature data in real-time, offering immediate alerts for any deviations. This ensures that all products, from investigational medicinal products to final biopharmaceutical products, are stored under optimal conditions. For example, biopharma products like monoclonal antibodies and cell-based therapies require stringent temperature control to maintain their stability and effectiveness. By eliminating manual checks, Setra’s solutions reduce the risk of human error and free up valuable time for your staff, allowing them to focus on critical tasks such as drug formulation and quality control.

Blood & Tissue Banks

Secure Storage Monitoring for Sensitive Biological Materials

Blood and tissue banks are highly regulated to ensure patient safety and the integrity of stored products. To comply with regulations set by the FDA and other governing bodies, red cells must only be stored in designated blood bank refrigerators. Maintaining specific air and core product temperatures is crucial, and alarm notifications should be sent immediately if there is any deviation.
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Blood is an excellent culture medium for bacterial growth and must be stored in approved blood bank refrigerators at +2 to +6°C (+35.6 to +45.8°F), with a shelf life of 35 days from donation. Hospitals have designated blood bank refrigerators in pathology and theatre storerooms, and strict regulations govern the handling and storage of blood to prevent waste and ensure patient safety. Understanding these tight constraints, Setra offers automated wireless temperature monitoring systems tailored to your needs, ensuring compliance.

Blood and tissue bank refrigerated storage units with labeled blood bags for secure monitoring

Compounding pharmacy cleanroom with isolator cabinets for sterile drug preparation

Compounding Pharmacies

Wireless Monitoring for Sterile Drug Preparation

The job of dispensing drugs and medicines, while maintaining proper environmental conditions, is essential for patient safety and product shelf-life. Regularly monitoring the temperatures of pharmacy fridges, cold rooms, robots, and warehouse stockrooms is imperative to meet FDA regulations and reduce potential wastage.
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Reacting swiftly to any temperature deviations is crucial for the safety of treatment stock. Installing a Wireless Temperature Monitoring System ensures 24/7 real-time monitoring, providing peace of mind and demonstrating compliance to the FDA, Joint Commission, and other regulatory authorities. Setra’s automated systems eliminate the need for manual checks, allowing pharmacy staff to focus on their primary tasks while ensuring regulatory compliance and optimal storage conditions.

Hospital Laboratories

Precision Monitoring for Critical Lab Environments

Hospital laboratories are critical environments that demand precision, compliance, and efficiency. Meeting the demands of legislative auditing bodies can be extremely time-consuming and prone to error, especially when hospital laboratories are exceptionally busy. Whether you manage a stand-alone microbiology lab or multiple hospital laboratories such as biochemistry, virology, immunology, or serology, our systems are tailored to meet stringent temperature compliance requirements.
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Manually taking temperature measurements from refrigerators, freezers, and incubators can be a labor-intensive process fraught with human error. This not only wastes valuable time but also increases the risk of losing irretrievable samples or expensive products due to equipment failure. Automating the temperature measurement process eliminates these risks, enabling your busy laboratory staff to focus on their primary tasks. By proactively addressing these needs, ensures your compliance is met effortlessly.

Hospital laboratory with automated analyzer and technician handling test tubes for sample processing

Medical device manufacturing cleanroom with technicians operating precision assembly equipment

Medical Device Manufacturing

Protecting Product Integrity in Regulated Manufacturing

Maintaining stringent environmental conditions is crucial in pharmaceutical and medical device manufacturing to ensure product safety and compliance with FDA regulations. Setra's wireless temperature monitoring systems provide real-time data logging and automated alerts, ensuring that your products are stored under optimal conditions and comply with regulatory standards.
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Our solutions are designed to eliminate manual temperature checks, reducing the risk of human error and freeing up valuable resources. For instance, in the production of temperature-sensitive medical devices like insulin pumps, precise environmental control is essential to prevent defects and ensure product integrity. Similarly, pharmaceuticals such as vaccines and biologics must be stored within specific temperature ranges to maintain their effectiveness. By implementing Setra’s systems, manufacturers can focus on innovation and production efficiency while ensuring that storage conditions are continuously monitored and maintained.

Vaccine Storage

Reliable Monitoring for Vaccine Efficacy

Proper storage of vaccines is critical to maintaining their efficacy and ensuring patient safety. Regulatory bodies such as the CDC and FDA require strict temperature control and monitoring for vaccine storage. Setra offers advanced wireless temperature monitoring systems that provide real-time data logging and automated alerts, ensuring vaccines are stored under optimal conditions.
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Our solutions eliminate the need for manual temperature checks, reducing the risk of human error and ensuring compliance with regulatory standards. Setra's monitoring systems help you maintain the integrity of your vaccine stock, prevent wastage, and ensure timely responses to any temperature deviations

Vaccine storage unit with digital temperature control and organized shelving for cold chain compliance

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