Rapid Microbiological Methods
Development, validation, transfer, applicability of methods and microbiological control in rapid and alternative methods.
ACM Pharma adapts to each need
The deployment of Rapid Microbiolocical Method is always a challenge in our laboratories because they require meeting a large number of pre-requisites and specific requirements. BacT / ALERT 3D® system, which is commonely operational in several applications (sterility test, microbial enumeration) has been installed in the laboratory for a few years and meets your expectations within the precise methodological frameworks of Eur Ph Chapter 2.6.27: Microbiological control of cellular products with advantages and disadvantage…
The validation of this Rapid Microbiolgical Method according to the recommendations of the Pharmacopoeias is necessary to demonstrate at least the equivalence and to optimize its performance.
Rapid microbial contamination in the BactAlert 3D system:
- Semi-quantitative enumeration of bacteria, yeasts and molds with a result in 24 to 48 hours.
- The goal of implementing this technology is to decrease the time to release results. Before setting up the method in routine control, validation according to regulatory and normative recommendations is an essential prerequisite in order to guarantee the reliability of the results and to demonstrate the performance of the alternative method versus the traditional method. It should be noted that this methodology can also be applied to pharmaceutical products as an alternative to the method of chapter 2.6.12 of the Ph Eur after having defined and applied an adapted validation protocol.
People above all
A team of engineers and pharmacists specializing in microbiology.
Material and methods
Latest generation equipment and our proactivity in integrating rapid / alternative methods and disruptive innovation technologies.
A customer portal for monitoring tests and analyzing trends
At your service, we identify your needs and implement our expertise for an adapted, efficient and tailor-made service.