The Application of Noninvasive Headspace Analysis to Media Fill Inspection

References

1. 1.↵
   1. Kreyenbuehl C.,
   2. Luemkemann J.

   Determination of Microbiological Growth in Media Filled Vials by Tuneable Diode Laser Absorption Spectroscopy (TDLAS). Presented at Pharma Kongress, Duesseldorf, Germany, April 2012.

   Google Scholar
2. 2.↵
   1. Bjorklund G. C.

   Frequency-Modulation Spectroscopy: A New Method for Measuring Weak Absorptions and Dispersions. Optics Letters 1980, 5 (1), 15–17.

   OpenUrlCrossRefPubMedGoogle Scholar
3. 3.↵
   1. Templeton A. C.,
   2. Han Y.-H. R.,
   3. Mahajan R.,
   4. Chern R. T.,
   5. Reed R. A.

   Rapid Headspace Oxygen Analysis for Pharmaceutical Packaging Applications. Pharm. Technol. 2002, 26 (7), 44–61.

   OpenUrlGoogle Scholar
4. 4.↵
   1. Lin T. P.,
   2. Hsu C. C.,
   3. Kabakoff D. B.,
   4. Patapoff T. W.

   Application of Frequency-Modulated Spectroscopy in Vacuum Seal Integrity of Lyophilized Biological Products. PDA J. Pharm. Sci. Technol. 2004, 58 (2), 106–115.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
5. 5.↵
   1. Mahajan R.,
   2. Templeton A. C.,
   3. Reed R. A.,
   4. Chern R. T.

   Frequency Modulation Spectroscopy: A Novel Nondestructive Approach for Measuring Moisture Activity in Pharmaceutical Samples. Pharm. Technol. 2005, 29 (10), 88–104.

   OpenUrlGoogle Scholar
6. 6.↵
   1. Cook I.,
   2. Ward K.

   Applications of Headspace Moisture Analysis for Investigating the Water Dynamics within a Sealed Vial Containing Freeze-Dried Material. PDA J. Pharm. Sci. Technol. 2011, 65 (1), 2–11.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
7. 7.↵
   1. Zuleger B.,
   2. Werner U.,
   3. Kort A.,
   4. Glowienka R.,
   5. Wehnes E.,
   6. Duncan D.

   Container/Closure Integrity Testing and the Identification of a Suitable Vial/Stopper Combination for Low-Temperature Storage at –80 °C. PDA J. Pharm. Sci. Technol. 2012, 66 (1), 453–465.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
8. 8.↵
   1. Sudo H.,
   2. O'Driscoll M.,
   3. Nishiwaki K.,
   4. Kawamoto Y.,
   5. Gammel P.,
   6. Schramm G.,
   7. Wertli T.,
   8. Prinz H.,
   9. Mori A.,
   10. Sako K.

   Development of a Nondestructive Leak Testing Method Utilizing the Head Space Analyzer for Ampoule Products Containing Ethanol-Based Solutions. PDA J. Pharm. Sci. Technol. 2012, 66 (5), 434–444.

   OpenUrlAbstract/FREE Full TextGoogle Scholar
9. 9.↵
   1. Lysfjord J.

   1. Veale J. R.

   New Inspection Developments. In Practical Aseptic Processing Fill and Finish, Lysfjord J., Ed.; Davis Healthcare International Publishing/PDA: Bethesda, MD, 2009; pp 305–372.

   Google Scholar
10. 10.↵
    Proposed Revisions to General Chapter Sterile Product Packaging—Integrity Evaluation <1207>. Pharmocopeial Forum, September 2014.

    Google Scholar
11. 11.↵
    FDA Guidance for Industry. Sterile Products Produced by Aseptic Processing—Current Good Manufacturing Practice. September 2004.

    Google Scholar
12. 12.↵
    1. McCullough K. Z.,
    2. Moldenhauer J.

    1. Cundell A.

    Failure investigations in response to adverse aseptic filling simulation results. In Microbial Risk and Investigations, McCullough K. Z., Moldenhauer J., Eds; PDA/Davis Healthcare International Publishing: Bethesda, MD, 2015; pp 541–560.

    Google Scholar
13. 13.↵
    1. Doelle H. W.

    Bacterial Metalbolism, 2nd ed.; Academic Press: New York, 1975; pp 738.

    Google Scholar
14. 14.↵
    1. Riedel T. E.,
    2. Berelson W. M.,
    3. Nealson K. H.,
    4. Finkel S. E.

    Oxygen Consumption Rates of Bacteria under Nutrient-Limited Conditions Appl. Environ. Microbiol. 2013, 79 (16), 4921–4931.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
15. 15.↵
    FDA Questions and Answers on Current Good Manufacturing Practices, Level 2 Guidance—Equipment. May, 2005.

    Google Scholar
16. 16.↵
    1. Baranyl J.,
    2. Roberts T.A.

    A Dynamic Approach to Predicting Bacterial Growth in Food. Int. J. Food Microbiol. 1994, 23 (3-4), 277–294.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
17. 17.↵
    1. Roesti D.

    Gas Headspace Analysis for Media Fill Inspection. Presented at the ECA Rapid Microbiological Methods Conference, Heidelberg, Germany, December 2014.

    Google Scholar
18. 18.↵
    1. Brueckner D.

    Determination of Microbial Growth by Laser Absorption Spectroscopy. Presented at the Aseptikon Microbiology Conference, Mannheim, Germany, September 2015.

    Google Scholar
19. 19.↵
    1. Monod J.

    Growth of Bacterial Cultures. Ann. Rev. Microbiol. 1949, 3 (1), 371–394.

    OpenUrlCrossRefWeb of ScienceGoogle Scholar
20. 20.↵
    1. Novick A.

    Growth of Bacteria. Ann. Rev. Microbiol. 1955, 9 (1), 97–110.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
21. 21.↵
    1. Zwietering M. H.,
    2. Jongenburger I.,
    3. Rombouts F. M.,
    4. Reit K. T.

    Modeling of the Bacterial Growth Curve. Appl. Environ. Microbiol. 1990, 56 (6), 1875–1811.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
22. 22.↵
    1. Lolas A. G,
    2. Metcalfe J. W.

    Evaluation of the Microbial Growth Potential of Pharmaceutical Drug Products and Quality by Design. PDA J. Pharm. Sci. Technol. 2011, 65 (1), 63–70.

    OpenUrlAbstract/FREE Full TextGoogle Scholar