Performance Survey and Comparison Between Rapid Sterility Testing Method and Pharmacopoeia Sterility Test
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DOI: 10.1007/s12247-017-9303-z
Abstract: The sterility test described in pharmacopoeial compendia requires a 14-day incubation period to obtain a valid analytical result. Therefore, the use of alternative methods to evaluate the sterility of pharmaceuticals, such as the BacT/Alert® 3D… read more here.
Keywords: sterility; testing method; sterility testing; sterility test ... See more keywords
A modern compendial automated and rapid sterility testing technology for cell and gene therapy products
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DOI: 10.1016/j.jcyt.2020.03.351
Abstract: Background & Aim Cell and Gene Therapies are currently being developed to treat different diseases. By design, those therapies have very short shelf lives compared to traditional sterile pharmaceutical drugs. Besides, Cell and Gene Therapies… read more here.
Keywords: sterility test; sterility; cell; cell gene ... See more keywords
Rapid Sterility Test Systems in the Pharmaceutical Industry: Applying a Structured Approach to their Evaluation, Validation and Global Implementation.
Sign Up to like & getrecommendations! Published in 2023 at "PDA journal of pharmaceutical science and technology"
DOI: 10.5731/pdajpst.2021.012672
Abstract: The current compendial sterility test has a 14-day incubation time and is often the time-limiting step in the Assess and Release Process of pharmaceutical products. There is an ever-increasing number of technologies available on the… read more here.
Keywords: time; validation; sterility; sterility test ... See more keywords