From 2017 to present day there have been more new drug approvals issued by the FDA than ever before. According to Pharmaceutical Commerce in 2017 alone 49% of FDA approved drugs were classified as temperature-sensitive products, requiring refrigeration (2-8°C) storage and transportation. Some even requiring below-zero or cryogenic temperatures. If these upper and lower values are exceeded, the products can be damaged. The consequence would be an increased risk to patients, and financial losses.
The utilization of a temperature monitoring system is essential in ensuring proper storage of assets. An automated data monitoring system can provide reliable, 24/7 monitoring, all while storing temperature data compliantly. With the correct monitoring system you can obtain visibility even while off site and quickly be alarmed when there is a excursion from your set parameters. In this application document we will look at some of the challenges of refrigeration monitoring and the top considerations for sourcing a comprehensive monitoring solution.
Temperature has many effects to extremely sensitive pharmaceutical drug products. This is mainly due to the proteins that make up many drug products. Proteins concentrated in the drug product react to changing ambient temperature conditions- especially to temperature fluctuations. On the other hand, freezing a drug product that requires ambient storage can alter its composition very negatively in turn minimizing its drug effectiveness on the patient.
However, not only drug products themselves or their component substances are endangered outside the permitted temperature range. Drug product storage containers or packaging are also affected: as below-freezing or extremely fluctuating temperatures can cause hairline cracks in ampoules and glass containers, or dissolve so-called leachable components out of the glass. The consequence can be contamination or even loss of sterility of the drug product.
The Testo Saveris Monitoring System is the complete Life Science environment solution developed by experts in the Life Science sector with 10 years of experience. Highly precise measurement technology, intuitively operable software and comprehensive services help you to carry out your work quickly, efficiently and in accordance with GxP regulations.
The Testo saveris 150 system was developed to meet the challenges and criteria of todays most stringent cold storage units, while providing compliance and reliable visibility. When considering a new or evaluating your current monitoring system, review the following criteria:
- Redundant measurement data with multiple layers of internal memory and battery operated data loggers in order to ensure continuous recording even in the event of a power outage.
- Multiple alarm options (SMS, e-mail, alarm-relay) when limit values are exceeded ,communication interrupted, low battery warning, probe failure, and power supply interrupted.
- Automated monitoring of temperature, relative humidity, and differential pressure. Easy to expand and scale.
- Comprehensive reporting options with option for automated reporting to email. Simple and easy access to raw data within the software.
- Wide selection of probes – for measurements from -200 °C to over +1000 °C.
- Probes with internal and external sensors – for flexible attachment on and in the refrigerator.
- 21 CFR part 11 compliant software
- Thermal mapping, qualification, validation, and calibration service packages - for long term security.