Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology

References

1. 1.↵
   1. Russell C.,
   2. Parsaei N.,
   3. Jones D. L.

   Validation of the Growth Direct^® System for Environmental Monitoring and Define Optimal Incubation Conditions. Eur. J. Parenter. Pharm. Sci. 2020, 25 (2), 1–13.

   OpenUrl
2. 2.↵
   1. Nguyen K.,
   2. Mills A.,
   3. Sage A.,
   4. Jones D.

   Validation of the Growth Direct^® System to Perform Pharmaceutical Water Bioburden Analysis. Eur. J. Parenter. Pharm. Sci. 2014, 20 (3), 85–93.

   OpenUrl
3. 3.↵
   1. Samson A.,
   2. Durusky A.,
   3. Carpenter B.,
   4. Jones D. L.,
   5. Intinarelli T.

   Validation of the Growth Direct^® System to Perform Pharmaceutical In Process Bioburden Analysis. IVT Network 2018, Jan 23.
4. 4.↵
   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. PLoS One 2010, 5 (1), e8609

   OpenUrlCrossRefPubMed
5. 5.↵
   1. Jones D.,
   2. Cundell T.

   Method Verification Requirements for an Advanced Imaging System for Microbial Plate Count Enumeration. PDA J. Pharm. Sci. Technol. 2018, 72 (2), 199–212.

   OpenUrlAbstract/FREE Full Text
6. 6.↵
   1. Murphy T.,
   2. Schwedock J.,
   3. Nguyen K.,
   4. Mills A.,
   5. Jones D.

   Evaluation of PDA Technical Report No 33. Statistics Testing Recommendations for a Rapid Microbiological Method Case Study. PDA J. Pharm. Sci. Technol. 2015, 69 (4), 526–539.

   OpenUrlAbstract/FREE Full Text
7. 7.↵
   1. van den Heuvel E.,
   2. Jones D.,
   3. Manju A.,
   4. Brosseau J.,
   5. Parsaei N.

   Primary Validation of the Growth Direct^® Bioburden System and Media. Eur. Pharm. Rev. 2020, 25 (5).
8. 8.↵
   1. Jones D. L.,
   2. Parsaei N.,
   3. van den Heuvel E.

   Primary Validation of the Growth Direct^® Environmental Monitoring System and Media. IVT Network 2020, 26 (1).
9. 9.↵
   1. Deutschmann S.,
   2. Carpenter B.,
   3. Duignan C.,
   4. Knutsen C.,
   5. Salvas J.,
   6. Wysocki L.,
   7. Plourde L.,
   8. Johnson L.,
   9. Eder W.

   A Systematic Approach for the Evaluation, Validation and Implementation of Automated Colony Counting Systems. PDA J. Pharm. Sci. Technol. 2022, 75 (6), 509–526. https://doi.org/10.5731/pdajpst.2021.012646

   OpenUrl
10. 10.↵
    1. Gordon O.,
    2. Berchtold M.,
    3. Staerk A.,
    4. Roesti D.

    Comparison of Different Incubation Conditions for Microbiological Environmental Monitoring. PDA J. Pharm. Sci. Technol. 2014, 68 (5), 394–406.

    OpenUrlAbstract/FREE Full Text
11. 11.↵
    1. Symonds I. D.,
    2. Martin D. L.,
    3. Davies M. C.

    Facility-Based Case Study: A Comparison of the Recovery of Naturally Occurring Species of Bacteria and Fungi on Semi-Solid Media When Incubated under Standard and Dual Temperature Conditions and Its Impact on Microbial Environmental Monitoring Approach. Eur. J. Parenter. Pharm. Sci. 2016, 21 (1), 7–15.

    OpenUrl
12. 12.↵
    1. Sage A.,
    2. Timas N.,
    3. Jones D.

    Determining Incubation Regime and Time to Results for Automated Rapid Microbiology EM Methods. Eur. J. Parenter. Pharm. Sci. 2014, 19 (2), 45–55.

    OpenUrl
13. 13.↵
    1. Moldenhauer J.

    Justification of Incubation Conditions Used for Environmental Monitoring. Am. Pharm. Rev. 2014, 17 (2), 25–29.

    OpenUrl
14. 14.↵
    1. Reasoner D. J.,
    2. Geldreich E. E.

    A New Medium for the Enumeration and Subculture of Bacteria from Potable Water. Appl. Environ. Microbiol. 1985, 49 (1), 1–7.

    OpenUrlAbstract/FREE Full Text
15. 15.↵
    1. Paris A.,
    2. Plourde-Awobi L.

    From Variable Operator Numeration to the Standardized 3P Station Automated Colony Counting on Environmental Monitoring Culture Media Plates. La Vague 2020, 66, 27–34.

    OpenUrl