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Drug delivery


Given the lack of standardisation on shape, size and material for closed-system transfer devices (CSTDs), many pharmaceutical companies are struggling to ensure their products work with the array of them in use worldwide. The problem is compounded when CSTDs – originally designed to protect users while handling drugs – are used to hold high-value biologics, for which compatibility issues could have major fi nancial consequences. Jim Banks speaks to Amgen process development scientist Twinkle Christian about potential solutions.


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losed-system drug transfer devices (CSTDs) are commonplace in hospitals, clinics and research labs – any environment in which drugs are handled. Their fundamental purpose is simple: protect users from coming into contact with a drug and, by extension, prevent the drug itself from being contaminated.


The US National Institute for Occupational Safety and Health (NIOSH) defines a CSTD as “a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system, and the escape of the hazardous drug or vapour concentrations outside the system”. As such,


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it has to preserve the quality of a drug until it is administered to a patient. Inevitably, there are risks in the use of CSTDs. If they are not properly handled, or if their design does not meet the requirements of a particular use case, then contaminants could enter the system or users could be exposed to harmful substances. If hazardous drugs, such as those used in chemotherapy, leak, then the consequences could be dire. Alongside risks to patients and healthcare professionals, there are other risks to take into account, principally the danger that high-value biologics could be rendered unviable by the use of a CSTD that is not fit for purpose.


World Pharmaceutical Frontiers / www.worldpharmaceuticals.net


Numstocker/www.shutterstock.com


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