Validation of Milliflex Quantum for Bioburden Testing of Pharmaceutical Products.

This article reports the validation strategy used to demonstrate that the Milliflex Quantum yielded non-inferior results to the traditional bioburden method. It was validated according to USP <1223>, European Pharmacopoeia 5.1.

Evaluation of the Recovery Rate of Different Swabs for Microbial Environmental Monitoring.

Unlabelled: Contact plates, dipslides, and swabs are used for the microbiological monitoring of surfaces in controlled environments such as pharmaceutical clean rooms. In the present study, three different swab types using two different methods (direct streaking on agar versus elution followed by membrane filtration) were evaluated. In a first study, representative surfaces in pharmaceutical clean rooms were artificially inoculated using three different environmental strains (in vitro study).

Comparison of Different Calculation Approaches for Defining Microbiological Control Levels Based on Historical Data.

Unlabelled: In the present work we compared different calculation approaches for their ability to accurately define microbiological control levels based on historical data. To that end, real microbiological data were used for simulation experiments. The results of our study confirmed that assuming a normal distribution is not appropriate for that purpose.

Comparison of different incubation conditions for microbiological environmental monitoring.

Unlabelled: Environmental monitoring represents an integral part of the microbiological quality control system of a pharmaceutical manufacturing operation. However, guidance documents differ regarding recommendation of a procedure, particularly regarding incubation time, incubation temperature, or nutrient media. Because of these discrepancies, many manufacturers decide for a particular environmental monitoring sample incubation strategy and support this decision with validation data.

Growth-promoting Properties of Different Solid Nutrient Media Evaluated with Stressed and Unstressed Micro-organisms: Prestudy for the Validation of a Rapid Sterility Test.

Currently, sterility testing in the pharmaceutical industry-a mandatory release test for all sterile drug products-takes an incubation time of at least 14 days and is based on liquid media according to the pharmacopoeias. The search is on for a rapid sterility test to reduce this rather long time frame. For this we have chosen the Millipore Milliflex Rapid Microbiology Detection System, which is based on solid nutrient media.

Identification of micro-organisms after milliflex rapid detection--a possibility to identify nonsterile findings in the milliflex rapid sterility test.

Unlabelled: The Milliflex Rapid System is used as a rapid microbiological method based on adenosine triphosphate (ATP) bioluminescence in the pharmaceutical industry to quantify the amount of micro-organisms present in water and in bioburden samples. The system can also be used for qualitative analyses, for example, to perform a rapid sterility test. This rapid sterility test has been successfully validated and implemented at Novartis and Sandoz.