FRESH PERSPECTIVES
Table 2 - Recovery of contamination in purifi ed water after diff erent incubation times; results are an average of 5 membrane replicates
Table 4 - List of customer strains from diff erent water sources and the time-to-fi nal result comparing Quantum and traditional method on R2A media at 32.5 +/- 2.5 °C
Table 3 - Comparison of fl uorescent micro-colonies of a stained membrane with macro-colonies of the same membrane after re-incubation
result, investigations are then simplifi ed, facilitating the implementation of appropriate root cause analysis or corrective/preventive action (CAPA) plans.
The ability to quickly detect and enumerate microbial contamination in water systems allows manufacturers to have better process control, higher product yields, and reduction in time-to-market. The product release can be accelerated and storage time decreased. The result is increased effi ciency and cost savings for the manufacturer as well as improved quality assurance of the product.
Acknowledgements
colonies were not yet visible at this time using traditional methods; 2) water samples from diff erent processes required 24 - 30hr incubation in order to achieve > 70% recovery as compared to the compendial method; and 3) detected micro-colonies can be recovered by membrane re- incubation after the staining step allowing for further identifi cation using existing ID methodologies.
Depending upon the isolate, the Millifl ex® Quantum System reduces the time-to-fi nal result of water-stressed microorganisms by a factor of at least 2 to 3 as compared to the traditional method. Strains that would normally require up to 5 days of incubation are recovered after 24 to 30 hours of incubation.
Dimensions and contrasts of the fl uorescent micro-colonies allow an easy visual count through the Millifl ex® Quantum Reader, without any background observed on the membranes. The fl uorescent count is similar to the colony count of the same membrane after re-incubation.
As the Millifl ex® Quantum method is non-destructive, re-incubation of stained membranes enables the identifi cation of water contaminants. As a
53 American Pharmaceutical Review | Fresh Perspectives 2013
The experiments presented in this article were performed by Beth Brescia in the Applications lab in Billerica, MA; Marilyn Vicente, Nathalie Valton El Khoury, Adrien Venchiarutti in the Applications lab in Molsheim, France; and Anne Baumstummler and Hervé Meder in R&D in Molsheim, France.
References 1.
2. 3. 4. 5. Meder, H; Baumstummler, A; Rouillon, S;
Contaminants in Water Samples Using the Millifl ex® Quantum System. International. July–August 2010, Vol. 8, No. 7, pp. 63–65.
Chollet, R; Ribault, S. Detection of Microbial BioProcess
Millifl ex® Quantum Rapid Detection System User Guide, 2010 Millipore Corporation. PF11940 Rev A, 02/2010
General Information Chapter <1231> Water for Pharmaceutical Purposes. In United States Pharmacopeia. USP: Rockville, MD.
General Information Chapter <1223> Validation of Alternative Microbiological Methods. In United States Pharmacopeia. USP: Rockville, MD.
General Chapter 5.1.6 Alternative Methods for Control of Microbiological Quality. European Pharmacopoeia.
In
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