USTR 2777a Validation Guide Pall Allegro Single-Use Mixers introduces the validation overview of Single-Use Mixers, including water leak test, drainage and drain valve operation, resistance to gamma sterilization, connections testing, extractables study, biological safety tests, physico-chemical tests and shelf life studies
This validation guide presents the testing performed on Pall Allegro single‑use mixers (200 L, 500 L and 1000 L) to demonstrate suitability for biotechnology and pharmaceutical use. It includes water leak tests, drainage performance, resistance to gamma sterilization, connections testing, extractables studies, biological safety, physico‑chemical tests and shelf‑life studies.
The document details test methods, results and conclusions, confirming that the mixers meet USP standards, can operate continuously for three days, and tolerate gamma doses up to 55 kGy. Updated surface‑area data for the upgraded 500 L and 1000 L models are also provided.