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.
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.

   OpenUrlCrossRefPubMed
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.

   OpenUrl
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 Text
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.

   OpenUrl
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 Text
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 Text
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 Text
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.
10. 10.↵
    Proposed Revisions to General Chapter Sterile Product Packaging—Integrity Evaluation <1207>. Pharmocopeial Forum, September 2014.
11. 11.↵
    FDA Guidance for Industry. Sterile Products Produced by Aseptic Processing—Current Good Manufacturing Practice. September 2004.
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.
13. 13.↵
    1. Doelle H. W.

    Bacterial Metalbolism, 2nd ed.; Academic Press: New York, 1975; pp 738.
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 Text
15. 15.↵
    FDA Questions and Answers on Current Good Manufacturing Practices, Level 2 Guidance—Equipment. May, 2005.
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 Science
17. 17.↵
    1. Roesti D.

    Gas Headspace Analysis for Media Fill Inspection. Presented at the ECA Rapid Microbiological Methods Conference, Heidelberg, Germany, December 2014.
18. 18.↵
    1. Brueckner D.

    Determination of Microbial Growth by Laser Absorption Spectroscopy. Presented at the Aseptikon Microbiology Conference, Mannheim, Germany, September 2015.
19. 19.↵
    1. Monod J.

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

    OpenUrlCrossRefWeb of Science
20. 20.↵
    1. Novick A.

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

    OpenUrlCrossRefPubMedWeb of Science
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 Text
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 Text