Zobrazeno 1 - 7
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pro vyhledávání: '"Alexandra, Staerk"'
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 71:206-224
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 , Ph. Eur. 5.1.6 and PDA Technical Report No. 33 and com
Publikováno v:
PDA Journal of Pharmaceutical Science and Technology. 69:383-398
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
Publikováno v:
PDA journal of pharmaceutical science and technology. 71(3)
This article reports the validation strategy used to demonstrate that the Milliflex
Publikováno v:
PDA journal of pharmaceutical science and technology. 71(1)
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
Publikováno v:
Practical Pharmaceutics ISBN: 9783319158136
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::44ea607e5c22ce40a269c642964054eb
https://doi.org/10.1007/978-3-319-15814-3_19
https://doi.org/10.1007/978-3-319-15814-3_19
Publikováno v:
PDA journal of pharmaceutical science and technology. 68(5)
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 incubat
Autor:
Jennifer C, Gray, Dieter, Morandell, Günther, Gapp, Nathalie, Le Goff, Gunther, Neuhaus, Alexandra, Staerk
Publikováno v:
PDA journal of pharmaceutical science and technology. 65(1)
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