Rapid Micro Biosystems has delivered the poster presentation “Primary Validation for an Automated Colony Counter per European Pharmacopeia 9.2, 5.1.6" at this year’s PDA Europe Annual Meeting.
The presentation explained how the Growth Direct System complies with the comprehensive manufacturer primary validation assay performance requirements defined in the recently revised European Pharmacopoeia 9.2 Chapter 5.1.6. This chapter discusses alternative methods for control of microbiological quality.
To ensure that Growth Direct complies with the directives required by the Europe Pharmcopeia for primary validation, Growth Direct underwent multiple rigorous tests. The data demonstrated that, when performing the analytical validation defined by the European Pharmacopeia, the Growth Direct complies with the assay performance requirements defined in the EP Ch 5.1.6.
Equivalence was demonstrated with the compendial method using media from two alternative suppliers: Millipore and BD for both bioburden and environmental testing formats.
Rapid Micro Biosystems said this validation is further supported by numerous systems being successfully validated at Top 20 Pharma companies and audited by regulatory bodies while in routine use at those sites.
Automated platform
The Growth Direct System is an automated rapid microbial enumeration platform suitable for in-process product testing, environmental, and water monitoring that integrates digital imaging, robotic cassette handling, incubation, and software control. Samples are prepared and loaded into the incubators.
The results reported in the poster presentation “Primary Validation for an Automated Colony Counter per EP 9.2, 5.1.6,” are available online.
The PDA Europe Annual Meeting was held in Berlin on 26-27 June 2018.