Contamination Control Procedures in Radiopharmaceuticals
Celsis ® rapid microbial detection instruments use ATP-bioluminescence technology to speed up the manufacturing and release process for radiopharmaceutical therapies by providing confident final sterility testing results in as little as 6 days, not just interim reads. Using a presence/absence test similar to the traditional USP procedure, it allows your laboratory to take action at a critical decision point soon after injection – and act fast in the event of contamination.
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- Reduces overall time and provides definitive results by eliminating the need for extensive follow-up testing and investigations to rule out contamination
- Lowers regulatory risk that comes with repeat test investigations, which draw further scrutiny and examination around potential false positives
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- Delivers quantifiable cost savings in the areas of personnel, consumable, inventory, and production
- The hard cost savings make a tangible business case beyond typical reduced quarantine duration, organizations expect a 14-day test and plan accordingly
Guidance on Implementation of Alternative RMMs
This Ebook addresses the technical, business, and data integrity issues in implementing ARMM technologies for the development, in-process control, and commercial release of drug products.
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Along with rapid sterility, the Celsis rapid detection platform for quality control testing can also be used to test raw materials, purified water, and in-process controls such as column chromatography resins. Unlike other rapid microbiological testing instruments for the quality control of radiopharmaceuticals, it has a wide sample compatibility range and flexible test method. The ability to test more than just final product sterility makes it an ideal solution for comprehensive radiopharmaceutical quality control through the manufacturing process.
Explore the Celsis® Rapid Microbial Detection Brochure
Gain insight into Celsis® technologies, platform capabilities, implementation considerations, validation support, and microbial detection applications across a range of product types.
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