Radiopharmaceutical Sterility and Endotoxin Testing

December 30, 2011

Radiopharmaceutical sterility testing is required during the sterilization validation process as well as for routine product release testing. USP <71> sterility testing is an official test to determine sterility of a product. Nova's understanding of USP <71> is important to the radiopharmaceutical industry because it allows us to assist in designing a sterility test validation process. USP <71> testing of radiopharmaceuticals is a scientifically complex process that must be performed by trained and qualified radiological and microbiological laboratory personnel. Nova's highly qualified and experienced staff provides the technical expertise and customer communication skills required for project completion.

USP <71> Sterility Testing of Radiopharmaceuticals requires the following: Outcome-based, comprehensive project planning to include preparation and assimilation of product batch book documents, testing and testing support utilizing Current Good Laboratory Practices (cGLP), compliance with all appropriate radiation safety measures and regulatory requirements, compliance with all appropriate microbiological safety and regulatory requirements, compliance with USP <71>  Sterility Testing, suitability testing to include USP <71> culture media growth promotion testing of aerobes, anaerobes, and fungi, sterility testing of selected number of test articles (determined by number of test articles per batch).

USP <85> Bacterial Endotoxin Testing is an official test to detect and quantify bacterial endotoxin that may be present in or on the test article to which the test has been applied. Nova's understanding of USP <85> is important to the radiopharmaceutical industry because it allows us to assist in designing a test validation process. USP <85> testing of radiopharmaceuticals is a unique process that must be performed by trained and qualified radiological and microbiological laboratory personnel. Nova's highly qualified and experienced staff provides the technical expertise and customer communication skills required for project completion.

USP <85> Bacterial Endotoxin Testing of Radiopharmaceuticals requires the following: Outcome-based, comprehensive project planning to include preparation and assimilation of product batch book documents, testing and testing support utilizing Current Good Laboratory Practices (cGLP), compliance with all appropriate radiation safety measures and regulatory requirements, compliance with all appropriate microbiological safety and regulatory requirements, compliance with USP <85> sections related to endotoxin standards preparation, determination of maximum valid dilution (MVD), establishment of endotoxin limits, and selection of appropriate endotoxin assay (i.e. gel-clot, turbidimetric, chromogenic).