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As noted previously, certain drugs require cold storage in order to maintain efficacy for delivery to patients. A well-monitored cold chain can help to ensure that drugs are properly handled throughout storage and transportation. But how can a manufacturer prove that the drugs are maintained and controlled adequately in a cold environment?
Temperature mapping, qualification and monitoring can help establish the temperature distribution within the storage area or transport. Understanding the design of the room or container – such as a truck, warehouse, reefer container or ship – can help to locate hot and cold spots. Electronic data logging monitors the environment so that the desired temperature range can be maintained through the room. This helps to avoid extremes of hot or cold.
In the event of an emergency, such mapping can help to determine the time required for conditions to return to the specific parameters required by the drug, which in turn can help determine if the product has exceeded is temperature excursion limits and thus ensure its efficacy has been maintained.
Qualification of temperature-controlled road vehicle and storage areas, as well as temperature and humidity monitoring systems for transport operations can help to ensure validation of the environment – enabling compliance with regulatory guidelines and cGMP principles.
West Contract Manufacturing has expanded its drug handling services, including cold chain solutions. Learn more on how we can help with solving the challenges of cold storage by reading this case study.
Contact us today to learn how West Contract Manufacturing can support your device manufacturing and drug handling requirements.
Temperature sensitive drug products, such as biologics or insulin, often require cold storage. But what, exactly is “cold”? We know it when we feel it, but often when one person is shivering, another is quite comfortable. Like humans, drug products may have specific tolerances to cold that depend upon the product.
Drug products such as biologics, vaccines and products whose chemical and physio-chemical stability depends on temperature put an added emphasis on pharmaceutical manufacturers to ensure proper handling, storage, transportation and dispensing. Maintaining a secure “cold chain” during the storage, handling and transportation of temperature-sensitive drugs, vaccines and blood products not only assures product quality and integrity for the benefit of the patient, but also helps to keep the manufacturer, hospital, pharmacist, physician and nurse in compliance with various laws, regulations, guidelines and codes.
For the pharmaceutical industry, the cost of developing new and innovative therapies will continue to rise (the cost of developing a drug is now estimated to be between $1.5 billion to more than $1.8 billion<sup>1</sup>).
Patrick Curran<sup>1</sup>, Vinod Vilivalam<sup>1</sup>, Suzanne Kuiper<sup>2</sup> and Derek Duncan<sup>2<br></sup><sup>1</sup>West Pharmaceutical Services, Inc. and <sup>2</sup>Lighthouse Instruments B.V.<p>An increasing number of pharmaceuticals including vaccines, stem cells and proteins require cold storage to maintain efficacy prior to use. However, the ability to maintain container closure integrity (CCI) during cold storage is not completely understood. </p>
In today’s increasingly complex drug delivery and device development landscape, a reliable contract manufacturing partner can become a distinct competitive advantage for pharmaceutical and device companies. West brings together the right combination of insights and infrastructure to help our customers reduce costs, mitigate risk and accelerate path to market.
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