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Cold Chain: A Chilling Tale of Temperature Regulated Environments

cold chain
GMP compliant refrigeration units are validated for prescription drugs and related products.

The route temperature regulated medications travel from manufacturer to patient is complex, with multiple checks and balances to assure patient safety and therapeutic effectiveness. The Cold Chain Logistics process is a central component ensuring efficiency in the pharmaceutical supply chain.

Certain pharmaceutical drug products, such as vaccines and biopharmaceuticals, must be maintained within a consistent temperature range for product potency and patient safety. Temperature Regulated Environments at WDSrx facilities in Florida, Texas, New Jersey, and Ohio accommodate temperature storage and shipping requirements for many types of sensitive pharmaceutical drug products.

TEMPERATURE REGULATED ENVIRONMENTS

Temperature Regulated Environments include Controlled Room Temperature (CRT) or Ambient Air Temperature between 20 and 25 degrees Celsius with relative humidity of 60%, Refrigerated Storage between 2-8 degrees Celsius, Frozen storage at minus 20 degrees Celsius and Deep Frozen storage at minus 80 degrees Celsius.

BIOPHARMACEUTICALS

Most conventional pharmaceutical products require no cold chain handling, but newer types of medications are changing the nature of the supply chain. Biopharmaceuticals incorporate human material into drug manufacturing to effectively treat patients. These drugs are used to treat a variety of conditions such as autoimmune diseases and cancer. Most biopharmaceuticals require special Cold Chain storage and handling to maintain potency as they move within the supply chain.

The opportunities that biopharmaceuticals present to the pharmaceutical supply chain are significant. In 2020, medications valued at $341 billion required 2-8 degree C storage and shipping.  The growth rate is expected to be 48% through 2024.

QUALITY ASSURANCE

WDSrx follows cGMP guidelines for pharmaceutical cold chain logistics established by the FDA and administered by the WDSrx Quality Assurance department.  These stringent requirements include immediately putting Cold Chain products away upon receipt, complete tracking of temperature storage conditions, validated storage areas and packaging, limited access to Controlled Substances and procedures to report and correct temperature excursions outside the optimal range. Written Standard Operating Procedures account for the nature of the drug products, local conditions, modes of transport and any seasonal variations experienced, as well as describe any special handling precautions. Appropriate training is provided to personnel and training records are maintained. 

Temperature mapping is repeated every three years and after any significant modification to the premises, facility layout or HVAC system modification. Refrigerators and freezers are validated, well maintained, equipped with alarms, have sensors for continuous monitoring, are calibrated regularly and are equipped with backup power sources.​

SPECIAL HANDLING AND SHIPPING

WDSrx arranges refrigerated trucking and temperature-controlled solutions. All carriers are validated to operate within the required temperature range. Drug products are transported in a manner that ensures the products will be maintained within an acceptable temperature range as defined in the approved labelling and supported by stability data. Shipping containers are qualified by the client to meet required specifications.

At WDSrx, cold chain capabilities provide Confidence Beyond Compliance maintaining high satisfaction levels with clients and their patients. 

For further information about Cold Chain Logistics and WDSrx watch our video on our YouTube Channel.

 

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 jsolomon@wdsrx.com or (561) 998-3885 x316.