The BacT/ALERT® 3D system was validated to determine the sterility of different types of
biopharmaceutical samples such as water for injection, unprocessed bulk, and finished bulk …

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 …

Sterility testing as described in the European Pharmacopoeia Chapter 2.6. 1 as well as the
United States Pharmacopeia Chapter 71 requires a 14 day incubation period of the test …

Sterility testing as described in the pharmacopoeia compendia requires a 14-day incubation
period to obtain an analytical result. Alternative methods that could be applied to evaluating …

Two sterility test methods, the ScanRDI® rapid sterility test and the United States
Pharmacopeia/European Pharmacopoeia/Japanese Pharmacopoeia (USP/EP/JP) …

This study compared an adenosine triphosphate (ATP)-based bioluminescence rapid
microbial method (RMM) with a conventional sterility method for biologics sample testing …

Background: Until recently, Canadian Blood Services (CBS) was performing quality control
sterility testing of blood components using three different processes. This study was …

To determine the sterility of pharmaceutical samples, highly conserved bacterial ribosomal
DNA sequences were used in a PCR‐based assay. Finished products, raw materials …

Sterility test is an established method for detecting the presence of viable forms of
microorganisms in or on finished pharmaceutical products. Sterility, in this sense, means that …

The emergence of cell therapy programs in large academic centers has led to an increasing
demand for clinical laboratories to assist with product sterility testing. Automated blood …