Radiopharmaceuticals, patient-specific preparations and modern therapy forms require a rethinking of the strategy for the final product release with regard to sterile testing. This is due to the often very short period of use. In very special cases, the pharmacopoeias allow the risk-based release and administration of these products before the prescribed pharmacopoeia examinations have been completed. In the interests of the greatest possible patient safety, the results of these tests should - wherever possible - be available prior to application. The classic pharmacopoeia methods are often less suitable for this than alternative rapid methods.
At Labor LS, we have already established suitable processes for numerous matrices. Furthermore, we are continuously working on expanding and optimizing rapid methods.
As a fully validated alternative method according to USP <1223>, Ph.Eur. 5.1.6 and PDA TR33, we offer you the sterility test using the Celsis® ATP bioluminescence method. This method reduces the incubation period by at least 7 days and thus leads to a significantly faster transmission of results.
In addition to the routine test, we also offer a comprehensive validation service for developing suitable processes in order to establish the Celsis® ATP bioluminescence process on the customer's side.
If you would like to commission us to carry out product tests using rapid methods or if you would like to establish this in your company, we will find the right and matrix-specific test strategy in close cooperation with you.
We would be pleased to advise you and prepare an individual quotation for you! For more information and enquiries, please contact our team of experts: