USP<825> and the Management of Radiopharmaceuticals

USP and the Management of Radiopharmaceuticals

Radiopharmaceuticals represent a unique class of drug product, requiring the use of equipment such as radionuclide generators and the preparation of patient-specific radiopharmaceutical doses. It’s critical that this is done correctly and in an environment where individualized patient needs and the safe handling of radioactive materials are controlled with a high level of care.

Clearly-defined standards support this. The right equipment, which conforms to these standards is important in making sure the activity is done properly.

In July of this year, the US Pharmacopeia Convention (USP) pre-released their uniform minimum standards for management of both sterile and nonsterile radiopharmaceuticals for humans and animals, outlined in; “General Chapter <825> Radiopharmaceuticals ‒ Preparation, Compounding, Dispensing, and Repackaging.”

The pre-release sets out definitions and descriptions for the various activities related to the provision of radiopharmaceuticals including their preparation, compounding, dispensing, and packaging. The new guidelines follow on from the 2008 revision of <797>, and the further section on radiopharmaceuticals published in 2015. After a roundtable held in February 2017 – which included stakeholders from the nuclear medicine community, regulatory agencies, and USP staff – the development of a General Chapter <825> was proposed.

The Importance of Labeling and Hygiene

The new guidance devotes whole sections to the importance of keeping an appropriate environment during the preparation of radiopharmaceuticals, including clean room regimes, hygiene, cleaning equipment, labeling, and air particulate matter monitoring. Labeling is specifically highlighted in the pre-release for human blood products with radionuclides. Air Particulate Matter should be monitored in preparation areas.

Hygiene proposals include standards for hand hygiene, the cleanliness of processing areas, disinfecting and the use of appropriate supplies.

Here at Blue Thunder Technologies we provide a range of disposable and non-disposable cleaning products and equipment to facilitate your work. Amongst our wide range of products, we offer custom label printing services, clean room supplies, and Remote Particulate Counters to help our clients deliver their services.

If you have any comments on the pre-release you can still have your say; <825> is available for public comment until November the 30th. Once finalized, you can be confident Blue Thunder Technologies’ extensive range of equipment and products will help to enable you to carry out your business in compliance with regulations.

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