Research ArticleResearch

Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products

Oliver Gordon, Marcel Goverde, Alexandra Staerk and David Roesti
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: https://doi.org/10.5731/pdajpst.2016.007450

Reference

  1. 1.↵
    1. Sandle T.
    Improving Microbiological Assurance for Bioburden Tests. Eur. Pharm. Rev. 2016, 21 (3), 41–44.
    OpenUrl
  2. 2.↵
    FDA. Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice, 2004.
  3. 3.↵
    Chapter 2.6.12. Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests; Ph. Eur., 7th ed.; 2010.
  4. 4.↵
    Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. In The United States Pharmacopeia and the National Formulary; United States Pharmacopeial Convention: Rockville, MD, 2011; USP 34-NF 29.
  5. 5.↵
    Chapter 5.1.6. Alternative Methods for Control of Microbiological Quality; In Ph. Eur., 7th ed.; 2010.
  6. 6.↵
    Chapter <1223> Validation of Alternative Microbiological Methods. In The United States Pharmacopeia and the National Formulary; United States Pharmacopeial Convention: Rockville, MD, 2011; USP 34-NF 29.
  7. 7.↵
    PDA Technical Report No. 33. Evaluation, Validation and Implementation of New Microbiological Methods; Parenteral Drug Association, Inc.: Rockville, MD, 2000.
  8. 8.↵
    1. Miller M. J.
    A Fresh Look at USP <1223> Validation of Alternative Microbiological Methods and How the Revised Chapter Compares with PDA TR33 and the Proposed Revision to Ph. Eur. 5.1.6. Am. Pharm. Rev. 2015, 18 (5), 22–35.
    OpenUrl
  9. 9.↵
    1. Miller M. J.
    Rapid Methods Update: Revisions to a United States Pharmacopeia Chapter. Eur. Pharm. Rev. 2015, 20 (4), 38–43.
    OpenUrl
  10. 10.↵
    1. Mach C. J.,
    2. Ball P. R.,
    3. Arbizzani L.
    The Advent of Rapid Microbiological Methods: Background, Applications, and Validation. Controlled Environments 2007, available from www.cemag.us.
  11. 11.↵
    1. Riley B.
    A Regulators View of Rapid Microbiology Methods. Eur. Pharm. Rev. 2011, 16 (5), 59–61.
    OpenUrl
  12. 12.↵
    1. Miller M. J.
    Microbiology Series. Article 3: The Implementation of Rapid Microbiological Methods (FDA Perspectives). Eur. Pharm. Rev. 2010, 15 (3), 18–21.
    OpenUrl
  13. 13.↵
    1. Miller M. J.
    Microbiology Series. Article 4: The Implementation of Rapid Microbiological Methods (EMA Perspectives). Eur. Pharm. Rev. 2010, 15 (4), 17–19.
    OpenUrl
  14. 14.↵
    1. Sandle T.
    Approaching the Selection of Rapid Microbiological Methods. J. Validation Technol. 2014, 20 (2), 1–10.
    OpenUrl
  15. 15.↵
    1. Gordon O.,
    2. Gray J. C.,
    3. Anders H. J.,
    4. Staerk A.,
    5. Schlaefli O.,
    6. Neuhaus G.
    Overview of Rapid Microbiological Methods Evaluated, Validated and Implemented for Microbiological Quality Control. Eur. Pharm. Rev. 2011, 16 (2), 9–13.
    OpenUrl
  16. 16.↵
    1. Goverde M.
    Rapid Microbiological Methods for Bioburden Testing. 2016, available from: www.rapidmicrobiology.com
  17. 17.↵
    1. Hodgkin P. D.,
    2. Lee J. H.,
    3. Lyons A. B.
    B Cell Differentiation and Isotype Switching Is Related to Division Cycle Number. J. Exp. Med. 1996, 184 (1), 277–281.
    OpenUrlAbstract/FREE Full Text
  18. 18.↵
    1. Schnitger K.,
    2. Njau F.,
    3. Wittkop U.,
    4. Liese A.,
    5. Kuipers J. G.,
    6. Thiel A.,
    7. Morgan M. A.,
    8. Zeidler H.,
    9. Wagner A. D.
    Staining of Chlamydia trachomatis Elementary Bodies: A Suitable Method for Identifying Infected Human Monocytes by Flow Cytometry. J. Microbiol. Methods 2007, 69 (1), 116–121.
    OpenUrlCrossRefPubMed
  19. 19.↵
    1. Wang X. Q.,
    2. Duan X. M.,
    3. Liu L. H.,
    4. Fang Y. Q.,
    5. Tan Y.
    Carboxyfluorescein Diacetate Succinimidyl Ester Fluorescent Dye for Cell Labeling. Acta Biochimica Biophysica Sinica 2005, 37 (6), 379–385.
    OpenUrl
  20. 20.↵
    1. Last'ovicka J.,
    2. Budinský V.,
    3. Spísek R.,
    4. Bartůnková J.
    Assessment of Lymphocyte Proliferation: CFSE Kills Dividing Cells and Modulates Expression of Activation Markers. Cell. Immunol. 2009, 256 (1–2), 79–85.
    OpenUrlCrossRefPubMed
  21. 21.↵
    1. Gray J. C.,
    2. Staerk A.,
    3. Berchtold M.,
    4. Hecker W.,
    5. Neuhaus G.,
    6. Wirth A.
    Growth-promoting Properties of Different Solid Nutrient Media Evaluated with Stressed and Unstressed Micro-organisms: Prestudy for the Validation of a Rapid Sterility Test. PDA J. Pharm. Sci. Technol. 2010, 64 (3), 249–263.
    OpenUrlAbstract/FREE Full Text
  22. 22.↵
    EMEA. Committee for Proprietary Medicinal Products (CPMP), Note for Guidance on Manufacture of the Finished Dosage Form, CPMP/QWP/486/95, 1996.
  23. 23.↵
    1. Blodgett R.
    Most Probable Number Determination from Serial Dilutions. 2010, available from: www.fda.gov.
  24. 24.↵
    Chapter <1227> Validation of Microbiological Recovery from Pharmacopeial Articles. In The United States Pharmacopeia and the National Formulary; United States Pharmacopeial Convention: Rockville, MD, 2011; USP 34-NF 29.
  25. 25.↵
    Chapter <1010> Analytical Data—Interpretation and Treatment. In The United States Pharmacopeia and the National Formulary; United States Pharmacopeial Convention: Rockville, MD, 2011; USP 34-NF 29.
  26. 26.↵
    1. Gurramkonda C.,
    2. Mupparapu K.,
    3. Abouzeid R.,
    4. Kostov Y.,
    5. Rao G.
    Fluorescence-based Method and a Device for Rapid Detection of Microbial Contamination. PDA J. Pharm. Sci. Technol. 2014, 68 (2), 164–171.
    OpenUrlAbstract/FREE Full Text
  27. 27.↵
    1. Irie K.,
    2. Scott A.,
    3. Hasegawa N.
    Investigation of the Detection Ability of an Intrinsic Fluorescence-Based Bioaerosol Detection System for Heat-Stressed Bacteria. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 478–493.
    OpenUrlAbstract/FREE Full Text
  28. 28.
    1. Bhusari P. K.,
    2. Tabor D. E.,
    3. Yamagata R.,
    4. Galinski M. S.
    Application of Flow Cytometry for Rapid Bioburden Screening in Vaccine Virus Production. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 445–452.
    OpenUrlAbstract/FREE Full Text
  29. 29.↵
    1. Flint S.,
    2. Walker K.,
    3. Waters B.,
    4. Crawford R.
    Description and Validation of a Rapid (1 h) Flow Cytometry Test for Enumerating Thermophilic Bacteria in Milk Powders. J. Appl. Microbiol. 2007, 102 (4), 909–915.
    OpenUrlPubMed
  30. 30.↵
    1. Hiom S.,
    2. Denyer S.,
    3. Talbot C.,
    4. Maillard J.-Y.,
    5. Spark P.,
    6. Smith J.
    A Preliminary Investigation into the Ability of Three Rapid Microbiological Methods To Detect Microorganisms in Hospital Intravenous Pharmaceuticals. PDA J. Pharm. Sci. Technol. 2013, 67 (4), 376–386.
    OpenUrlAbstract/FREE Full Text
  31. 31.↵
    1. London R.,
    2. Schwedock J.,
    3. Sage A.,
    4. Valley H.,
    5. Meadows J.,
    6. Waddington M.,
    7. Straus D.
    An Automated System for Rapid Non-Destructive Enumeration of Growing Microbes. 2007, available from: http://dx.doi.org/10.1371/journal.pone.0008609.
  32. 32.↵
    1. Farajnia S.,
    2. Hassan M.,
    3. Hallaj Nezhadi S.,
    4. Mohammadnejad L.,
    5. Milani M.,
    6. Lotfipour F.
    Determination of Indicator Bacteria in Pharmaceutical Samples by Multiplex PCR. J. Rapid Methods Automation Microbiol. 2009, 17 (3), 328–338.
    OpenUrl
  33. 33.↵
    1. Klingspor L.,
    2. Jalal S.
    Molecular Detection and Identification of Candida and Aspergillus spp. from Clinical Samples Using Real-time PCR. Clin. Microbiol. Infec. 2006, 12 (8), 745–753.
    OpenUrlCrossRefPubMedWeb of Science
Back to top

In This Issue

Print
Download PDF
Article Alerts
Email Article
Citation Tools
Validation of Milliflex® Quantum for Bioburden Testing of Pharmaceutical Products
Oliver Gordon, Marcel Goverde, Alexandra Staerk, David Roesti
PDA Journal of Pharmaceutical Science and Technology May 2017, 71 (3) 206-224; DOI: 10.5731/pdajpst.2016.007450
Twitter logo Facebook logo Mendeley logo

Jump to section

Keywords