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 …

For several years, automated colony counting systems have been available with varying
degrees of automation. Ever more sophisticated instruments are now increasingly used in …

Manufacturing of pharmaceutical products, whether small molecules or biotherapeutics such
as oligonucleotides, monoclonal antibodies, recombinant proteins, vaccines, and blood and …

Microbial testing performed in support of pharmaceutical and biopharmaceutical production
falls into three main categories: detection (qualitative), enumeration (quantitative), and …

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 …

Microbial contamination may compromise the efficacy and safety of pharmaceutical
products. Microbial enumeration tests are required by most of the pharmacopeial compendia …

The purpose of this paper is to provide guidance and drive consistency in regards to
microbial control for manufacturers of low bioburden bulk biologics. This paper provides …

Environmental monitoring represents an integral part of the microbiological quality control
system of a pharmaceutical manufacturing operation. However, guidance documents differ …

In this report, we review the validation methods and criteria specified in the PDA Technical
Report No. 33 “Evaluation, Validation, and Implementation of New Microbiological Testing …

The validation of the Growth Direct system is described for the automated incubation and
counting of microbial colonies on R2A media plates derived from a water bioburden test …