Cold Chain in the Pharma Industry
There is a new focus on drugs that must be kept at controlled room temperature (CRT) – this is usually defined as 20°C to 25°C. In recent years, instances of improper vaccine storage have been reported. An estimated 17% to 37% of providers expose vaccines to improper storage temperatures, and refrigerator temperatures are more commonly kept too cold than too warm.
To monitor the cold chain process in the medical and pharmaceutical industry, Lascar offers a range of low cost USB data loggers pre-programmed to meet specific temperature requirements for various cold chain applications. With kits available to monitor pharmaceutical products, blood and platelets in transportation, your cold chain needs are covered.
What Do The Experts Say?
“The Centres for Disease Control and Prevention (CDC) is the leading national public health institute of the United States. The CDC have a set of guidelines for maintaining and managing the vaccine Cold Chain, our products meet these guidelines.
The majority of commonly recommended vaccines require storage temperatures of 2°C to 8°C and must not be exposed to freezing temperatures. Whereas other vaccines must be stored in a continuously frozen state -15°C with no freeze-thaw cycles. Our Cold Chain loggers are perfect for these regulations, they are cost-effective, multi-use loggers pre-programmed with set sample rates and alarms for monitoring Chilled Goods, Frozen Goods and Ambient Pharmaceutical, simply press an on-board button to start logging”
To regulate the pharmaceutical industry, a standard temperature and humidity atmosphere is the key to guarantee quality. Therefore, it’s very important to monitor and log the data of temperature and humidity for pharmaceutical companies, cold chain logistic, drug distributors, hospitals, and medical research institute in the process of production, warehouse storage, transportation, and distribution.
Medications and medical devices have a certain range of adaption in terms of temperature and humidity. Medicines should not be exposed to extreme temperatures or humidity, or the integrity will be affected, i.e. may be ineffective or even dangerous.
As a basic requirement for GMP, GSP, FDA, GLP and other specifications, temperature and humidity data should be objective and secure from alteration, inadvertent erasures, or loss shall be maintained for back up use.
ZOGLAB temperature and humidity data loggers manages to measure and record temperature and humidity data, give alarms when data is out of limited range, and build monitoring network systems.