Temperature Data Monitoring Solutions for Advanced Therapies
100% Compliant and Audit-Proof
100% Compliant and Audit-Proof
In the highly-regulated industry of manufacturing and developing advanced therapy medicinal products (ATMPs) for patients, including cell and gene therapies (CGTs), compliant monitoring under Good Manufacturing Practice is essential. ELPRO supports biotechnology industry innovation and leading life sciences therapeutics companies with comprehensive, cloud-based central monitoring for laboratories, cleanrooms, clean areas, warehouses and storage rooms and with monitoring solutions for the temperature controlled supply chain. From biotech research start-ups to mature personalized therapeutics and tissue manufacturing operations, ELPRO systems help ensure FDA-approved, compliant biotech companies worldwide.
Trusted biopharmaceutical life science monitoring solutions and and compliant audit-proof data integrity.
Your partner in GMP, GDP, and GLP. Including temperature mapping of laboratories, rooms and equipment.
Flexible and adaptive systems that can grow with your labs and company, whatever the pace.
Peace of Mind
Redundant technology that protects your data, ensures integrity and inspires confidence your work is secure.
Easy Reporting and Analysis
Automated processes and easy reporting
GAMP5 validated solutions and FDA CFR 21 Part 11 compliant
Rest easy knowing your valuable product and research are protected with a system backed by over three decades of experience.
Cold chain temperature monitoring of medicines, vaccines, tissue samples, and advanced therapies in transit–from API storage or distribution all the way to the patient–is extremely complex. The COVID pandemic that disrupted supply chains in the pharmaceutical industry, highlighted the importance of a robust, Pharma, life science and healthcare logistics infrastructure to store and transport vaccines. However, there are numerous applications and some are very unique and sensitive to time, temperature, humidity, shock, light and other extraneous factors. Proper temperature and humidity monitoring throughout the pharma logistics journey is critical.
Maintaining precise temperature is key to the quality of pharmaceuticals, but also many other products and industrial processes. Therefore, ensuring the proper condition and calibration of temperature data logger equipment and sensors within refrigerators, freezers, ULT freezers, cryo containers, or incubators is crucial to the daily work in laboratories when performing processing, analysis, or storage. Documentation and temperature monitoring of all lab equipment is key for precise analysis, traceability, and compliance.
The monitoring of cleanrooms is a complex project. It requires a disciplined approach and advanced planning and integration with the cleanroom builder. Whether they are in laboratories or production facilities, in cleanrooms the products are in an unpackaged state and are therefore particularly vulnerable. The entire system must also be qualified and cleanly documented. The requirements defined in the GMP guidelines are correspondingly high. You must monitor various parameters, ensure the data are processed correctly, and then transferred to other systems.
In many pharma laboratories -20 °C freezers play an important role. From a temperature monitoring perspective, battery powered data loggers can still withstand the conditions of long-term storage. However, the right battery type choice is critical. While alkaline batteries loose performance within a few days when stored frozen, lithium batteries can easily withstand temperatures down to -30 °C for one year or more.
+2 °C to +8 °C refrigerators are important equipment in laboratories, pharmacies, hospitals and many other places where temperature-sensitive products or samples are conditioned or stored. Pharmaceutical grade refrigerators are guaranteed to maintain+2 °C to +8 °C on any rack/drawer. This is not the case with most household appliances.
Whether GMP, GDP or HACCP: cold rooms and warehouses must be monitored by an independent monitoring system - regardless of whether raw materials or pharmaceutical products are involved. During the qualification of the room, it is determined at which points the temperature and relative humidity must be monitored.
Biotechnology industry environments are highly-regulated and require maximum traceability and data integrity. GDP, GLP, and GMP compliant solutions are required for your biotechnology laboratory, research and storage facilities. Gain peace of mind and ensure worry-free audits. From pharmaceuticals to the development of advanced therapeutics, ELPRO GxP experts can guide your team through the entire qualification process. Whether you're a start-up or mature biopharma manufacturing facility, ELPRO GxP validation engineers can assist with every facet of keeping your facility 100% compliant and audit-proof.