USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems. Prefilled syringes, parenteral drugs, and many therapeutic ...
Proposed guidance documents assist drug manufacturers in qualifying single-use systems for commercial drug production. The increased market value and small batch sizes of biologics has led to a boom ...
Dr Bettine Boltres, Product Manager, Pharmaceutical Tubing, SCHOTT, Germany in this white paper, touches on a risk-based approach of the evaluation and describes important facts to consider when ...
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