David Roesti, Senior Facilitator RMM+Global Support, Novartis Pharma Stein AG recently published in article in the Pharmig Winter Edition (free download for Pharmig members) that discusses his company’s use of an RMM Launch Center to “evaluate, validate and implement rapid microbiological methods (RMMs) for microbiological QC testing.” The article discusses the various rapid methods that have been evaluated at the center. The article presents details on different methods that have been validated.
According to the article, in 2009, Novartis established the RMM Launch Center, a center of excellence in Stein, Switzerland, to evaluate, validate and implement rapid methods without duplicating efforts across multiple Novartis sites. The center was established to address the common challenges associated with the implementation and validation of RMMs, specifically that the process can be time consuming and require specific expertise.
The article notes that RMMs may significantly reduce the time-to-result of microbiological testing (and thus have the potential to reduce time to product release), and points out that “the use of RMMs is highly encouraged by some health authorities, such as the FDA, and there are already a number of documents providing guidance on method validation (USP <1223>, Ph. Eur. 5.1.6, PDA Technical Report #33).”
The RMM Launch center, based on the article, validates a method initially. It is then transferred to other sites – with the site needing to only complete their method transfer process and demonstrate the “suitability of their products for the method of interest.” By centralizing the process of validating and implementing rapid methods, Novartis has created a streamlined approach to updating their overall microbiological quality control.
For water testing, Novartis validated the Growth DirectTM System in 2011 the article states that the system is in use at two Novartis sites.
Water Testing with Growth DirectTM
Ph. Eur. Monographs state that at least five days of incubation time are needed for enumeration of visually detectable colonies for purified, highly purified water and water-for-injection (WFI). But the RMM Launch Center’s method using the Growth DirectTM System was validated requiring only 90 hours of “incubation to obtain statistically equivalent results to visual enumeration after 7 days.” As Roesti explains, the system illuminates autoflorescent molecules with blue light, and detects the subsequent yellow-green light they emit with a sensitive CCD chip, making it possible to detect smaller colony sizes than can be seen with the human eye.
He notes that readings are performed every six hours at Novartis, and that the system evaluates the consecutive images, so the software “automatically distinguish[es] between growing microbial colonies and other fluorescent particles potentially present on the membrane.” The Growth DirectTM System, which was presented and approved during an audit by Swiss health authorities, has the added benefit of providing early warnings if microbial limits are exceeded.
Roesti concludes that “RMMs can noticeably shorten throughput times” while offering automation and paperless solutions (when integrated with LIMS). “The Novartis RMM Launch Center strives to acquire a portfolio of validated state-of-the-art rapid microbiological methods… and propagate the use of these methods within the Novartis group.”
The article “Rapid Microbiological Methods” about Novartis’ RMM Launch Center is available for purchase on the Pharmig website by clicking here. Additionally, discover details about water testing with the Growth DirectTM System by clicking here.