Evaluation of growth based rapid microbiological methods for sterility testing of vaccines and other biological products

S Parveen, S Kaur, SAW David, JL Kenney… - Vaccine, 2011 - Elsevier
Most biological products, including vaccines, administered by the parenteral route are
required to be tested for sterility at the final container and also at various stages during …

Single-cell detection: test of microbial contamination using capillary electrophoresis

AW Lantz, Y Bao, DW Armstrong - Analytical chemistry, 2007 - ACS Publications
Single cells of bacteria and fungi were detected using a capillary electrophoresis-based test
for microbial contamination in laboratory samples. This technique utilizes a dilute cationic …

Reducing the risk of non-sterility of aseptic handling in hospital pharmacies, part A: risk assessment

FA Boom, JM Ris, T Veenbaas… - European Journal of …, 2022 - ejhp.bmj.com
Objectives To determine prospectively the sources of risk of non-sterility during aseptic
handling and to quantify the risks of each of these sources. Methods A risk assessment (RA) …

[HTML][HTML] Performance survey and comparison between rapid sterility testing method and pharmacopoeia sterility test

A Bugno, DPS Saes, AAB Almodovar, K Dua… - Journal of …, 2018 - Springer
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 …

[HTML][HTML] Application of the BacT/ALERTR 3D system for sterility testing of injectable products

A Bugno, RS Lira, WA Oliveira… - Brazilian journal of …, 2015 - SciELO Brasil
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 …

Evaluation of the ScanRDI® as a rapid alternative to the pharmacopoeial sterility test method: comparison of the limits of detection

R Smith, M Von Tress, C Tubb… - PDA Journal of …, 2010 - journal.pda.org
Two sterility test methods, the ScanRDI® rapid sterility test and the United States
Pharmacopeia/European Pharmacopoeia/Japanese Pharmacopoeia (USP/EP/JP) …

[BOOK][B] Disinfection and decontamination: a practical handbook

J Moldenhauer - 2018 - books.google.com
This book describes various methods of decontamination and how the methods work. There
is a discussion of the various cleaning and disinfection methods utilized, along with details …

Overview of rapid microbiological methods

J Moldenhauer - … of bacterial detection: biosensors, recognition receptors …, 2008 - Springer
In recent years there have been significant advances in microbiology, achieved through the
sister sciences of chemistry, molecular biology, and computer aided imaging. These have …

[PDF][PDF] The sterility tests

S Sutton - Rapid Sterility Testing. Parenteral Drug Association, 2011 - academia.edu
BACKGROUND The compendial Sterility Test is not a test for product sterility. This is not a
new, nor a particularly insightful observation. It has been frequently presented as a flawed …

Rapid identification of Candida albicans in blood by combined capillary electrophoresis and fluorescence in situ hybridization

AW Lantz, B Bisha, MY Tong, RE Nelson… - …, 2010 - Wiley Online Library
A CE method based on whole‐cell molecular labeling via fluorescence in situ hybridization
was developed for the detection of Candida albicans in whole blood. Removal of potentially …