A Systematic Approach for the Evaluation, Validation, and Implementation of Automated Colony Counting Systems

S Deutschmann, B Carpenter, C Duignan… - PDA Journal of …, 2022 - journal.pda.org
For several years, automated colony counting systems have been available with varying
degrees of automation. Ever more sophisticated instruments are now increasingly used in …

Multisite qualification of an automated incubator and colony counter for environmental and bioburden applications in pharmaceutical microbiology

HJ Anders, D Männle, W Carpenter, W Eder… - PDA Journal of …, 2023 - journal.pda.org
Traditional microbiological techniques have been used for well over a century as the basis
for contamination testing of pharmaceutical products and processes. With more recent focus …

Review on Enforcement of Alternative Microbiological Methods in the Pharmaceutical Industry.

HA Prada-Ramirez - Systematic Reviews in Pharmacy, 2023 - search.ebscohost.com
The use of alternative microbiological methods has been encouraged by the United States
Pharmacopeia (USP) guidelines, since they offer several advantages over the reference …

Top-down evaluation of the matrix effects in microbial enumeration test uncertainty

FRS Dias, FR Lourenço - Journal of microbiological methods, 2020 - Elsevier
Microbial contamination may compromise the efficacy and safety of pharmaceutical
products. Microbial enumeration tests are required by most of the pharmacopeial compendia …

[HTML][HTML] How to validate an automated colony counter

K George - 2013 - researchsquare.com
The manual process of counting microbial colonies on agar plates can be time-consuming
as it is generally performed by scientists using a light box and pen method. The results can …

Evaluation of an Automated System for the Counting of Microbial Colonies

E Heuser, K Becker, EA Idelevich - Microbiology Spectrum, 2023 - Am Soc Microbiol
Counting of microbial colonies is a common technique employed in research and
diagnostics. To simplify this tedious and time-consuming process, automated systems have …

[PDF][PDF] Ready for the count? Back-to-basics review of microbial colony counting

T Sandle - J. GXP Compliance, 2020 - researchgate.net
Microbiological laboratories remain reliant on the accurate determination of the number of
colony forming units (CFUs) on growth media; this is notwithstanding advances with rapid …

In search of a counter you can count on: relative efficacy of human visual and automated colony counting

LM Young, DJ Rieman, L Walden… - Letters in applied …, 2018 - academic.oup.com
To evaluate comparative efficiency of traditional vs automated colony counting methods,
cultures of Escherichia coli (ATCC 25945), Staphylococcus epidermidis (ATCC 12225) …

Performance equivalence and validation of the Soleris Automated System for quantitative microbial content testing using pure suspension cultures

BJ Limberg, K Johnstone, T Filloon… - Journal of AOAC …, 2016 - academic.oup.com
Abstract Using United States Pharmacopeia-National Formulary (USP-NF) general method<
1223> guidance, the Soleris® automated system and reagents (Nonfermenting Total Viable …

[PDF][PDF] Accuracy of plate counts

S Sutton - Journal of validation technology, 2011 - microbiologynetwork.com
“Microbiology Topics” discusses various topics in microbiology of practical use in validation
and compliance. We intend this column to be a useful resource for daily work applications …