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.
21 CFR Compliant Systems
21 CFR is the part of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records. Part 11 in particular defines the criteria under which electronic records are considered trustworthy, reliable, and equivalent to paper records. If you're required to maintain encrypted and auditable monitored data, review Lascar's range of USB and WiFi 21 CFR compliant products or take a look at Lascar's unique 21 CFR Compliant Cloud monitoring system.
Need A Custom Logger?
Lascar can customise any of our products to suit specific needs. Recently one customer storing immunoglobulins needed a data logger with unique alarms.
Their problem: Immunoglobulins have to be stored between 2°C and 8°C however have a resistance to temperatures up to 25°C for a maximum of 1 week.
What we did: Created a custom EL-PDF-1 data logger with the following pre-set alarm states: Low Alarm: 2°C, instant / Cumulative Zone: 8°C to 25°C for 1 week (any values recorded in this range prior to the alarm triggering provide an amber warning) / High Alarm: 25°C, instant.
Is there a custom configuration we could create for you? We can customise even for quite small quantities, please contact us to discuss your requirements.
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."
- Vaccine Storage
- Cold Chain in the Pharma Industry
- 21CFR Part 11 Compliant Data Loggers
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