Evaluation of an ATP-bioluminescence rapid microbial screening method for in-process biologics

S Spaeth, Q Tran, Z Liu - PDA Journal of Pharmaceutical Science …, 2018 - journal.pda.org
This study compared an adenosine triphosphate (ATP)-based bioluminescence rapid
microbial method (RMM) with a conventional sterility method for biologics sample testing …

[PDF][PDF] Rapid Methods the Next Phase: A Framework for Multi-Product Adoption of Rapid Sterility Testing

M Guest, S Drinkwater, K Capper - Biopharma Asia, 2022 - researchgate.net
The use of adenosine triphosphate (ATP) bioluminescence detection is an established
technique to determine the presence of microorganisms in pharmaceutical, consumer …

Adenosine triphosphate bioluminescence analysis for rapid screening of microbial contamination in non-sterile pharmaceutical samples

L Jimenez - PDA Journal of Pharmaceutical Science and …, 2004 - journal.pda.org
An Adenosine Triphosphate (ATP) bioluminescence system was compared and validated
against standard methods for rapid microbiological monitoring of several non-sterile …

The uses and abuses of rapid bioluminescence-based ATP assays

G Shama, DJ Malik - International journal of hygiene and environmental …, 2013 - Elsevier
Bioluminescence-based ATP testing of solid surfaces has become well established in the
food processing industry as part of general hazard analysis and critical control points …

[PDF][PDF] A Rapid and Nondestructive Method for Microbiological Testing in Pharmaceutical Manufacturing

A Sage, J Schwedock, R London… - American …, 2006 - rapidmicrobio.com
Improving the performance of pharmaceutical microbiological quality control (QC) testing is
often included in the goals of the FDA's Process Analytical Technology initiative. That a …

Identification of micro-organisms after Milliflex Rapid detection—A possibility to identify nonsterile findings in the Milliflex rapid sterility test

JC Gray, D Morandell, G Gapp, N Le Goff… - PDA Journal of …, 2011 - journal.pda.org
The Milliflex Rapid System is used as a rapid microbiological method based on adenosine
triphosphate (ATP) bioluminescence in the pharmaceutical industry to quantify the amount of …

[PDF][PDF] Concurrent Evaluation of both Compendial and Rapid Methods (ATP Bioluminescence) for Monitoring Water Quality in Pharmaceutical Manufacturing

E Bagur - Eur Pharm Rev, 2009 - Citeseer
Much has been published elsewhere about the limitations of the compendial microbiological
methods and the needs of current Pharmaceutical manufacturing, in particular related to the …

Validation of the BacT/ALERT® 3D System for Rapid Sterility Testing of Biopharmaceutical Samples

L Jimenez, N Rana, J Amalraj, K Walker… - PDA Journal of …, 2012 - journal.pda.org
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 …

[PDF][PDF] The Rush to Rapid Microbiological Methods–Or Not

J Moldenhauer - Eur. Pharm. Rev, 2017 - academia.edu
© Khamkhlai Thanet/Shutterstock. com to provide techniques for evaluating media to use,
how to manufacture stressed organisms, and how to be sure that the rapid method allowed …

[CITATION][C] Rapid microbiological testing of biologics products using atp bioluminescence

S Ramsey, S Parikh - Cytotherapy, 2021 - Elsevier