Cold Chain Capability. Consistency of temperature within the pharmaceutical supply chain.
Temperature Regulated Environments are an important component of the 3PL pharmaceutical supply chain and pharma logistics.
Certain pharmaceutical drug products must be maintained within a consistent temperature range for product potency and patient safety. Temperature Regulated Environments at WDSrx facilities in Boca Raton, FL and in Sugar Land, TX accommodate temperature requirements for many types of sensitive pharmaceutical drug products.
Temperature-regulated Environments include Control Room Temperature (CRT) between 20 and 25 degrees Celsius with relative humidity of 60%, Refrigerated storage ranging from 2-8 degrees Celsius and Frozen storage at around minus 15 degrees Celsius.
The majority of pharmaceutical drug products remain stable within a CRT environment. Most commonly recommended vaccines require Refrigerated environments. Certain vaccines and other products must be stored in a continuously frozen state. Pharma logistics, specifically, Biologics, typically require extremely cold temperatures between minus 20 to minus 80 degrees Celsius to remain viable.
WDSrx follows cGMP guidelines for pharmaceutical cold chain logistics established by the FDA. These stringent requirements include complete tracking of temperature storage conditions, validated storage areas, controlled access to Controlled Substances, current documentation and written procedures to handle temperature excursions outside the optimal range.
Multiple and redundant security systems record movement, temperature, humidity and other metrics throughout the facility for constant and real-time monitoring. Disaster recovery action plans are regularly reviewed in case of sudden weather-related or other emergencies.
Are any Controlled Substances (CII) included in your return? If so, please press "Yes" and complete the DEA 222 Request Form. You can also contact Jason Solomon at firstname.lastname@example.org or (561) 998-3885 x316.