PT  - JOURNAL ARTICLE
AU  - Oliver Gordon
AU  - Marcel Goverde
AU  - Alexandra Staerk
AU  - David Roesti
TI  - Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products
AID  - 10.5731/pdajpst.2016.007450
DP  - 2017 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2016.007450
4099  - http://journal.pda.org/content/early/2017/02/13/pdajpst.2016.007450.short
4100  - http://journal.pda.org/content/early/2017/02/13/pdajpst.2016.007450.full
AB  - 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>, Ph. Eur. 5.1.6 and PDA Technical Report No. 33 and comprised the validation parameters Robustness, Ruggedness, Repeatability, Specificity, Limit of Detection and Quantification, Accuracy, Precision, Linearity, Range and Equivalence in Routine Operation. For the validation, a combination of pharmacopeial ATCC strains as well as a broad selection of in-house isolates was used. In-house isolates were used in stressed state. Results were statistically evaluated regarding the pharmacopeial acceptance criterion of ≥70% recovery compared to the traditional method. Post-hoc test power calculations verified the appropriateness of the used sample size to detect such a difference. Furthermore, equivalence tests verified non-inferiority of the rapid method as compared to the traditional method. In conclusion, the rapid bioburden on basis of the Milliflex® Quantum was successfully validated as alternative method to the traditional bioburden test.