Clarifications on the Intended Use of USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests

References

1. 1.↵
   U.S. Pharmacopeial Convention, General Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

   Google Scholar
2. 2.↵
   Federal Food, Drug, and Cosmetics Act (FD&C Act) of 1938. FDA Web site. https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act (accessed March 2024).

   Google Scholar
3. 3.↵
   Code of Federal regulations – Title 21 – Food and Drugs. FDA Web site. https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs (accessed March 2024).

   Google Scholar
4. 4.↵
   U.S. Pharmacopeial Convention, General Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

   Google Scholar
5. 5.↵
   Microbiological Chapters – Glossary. Pharm. Forum 2022, 48 (5).

   Google Scholar
6. 6.↵
   U.S. Pharmacopeial Convention, General Chapter <1229.3> Monitoring of Bioburden. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

   Google Scholar
7. 7.↵
   U.S. Pharmacopeial Convention, General Chapter <1234> Vaccines for Human Use—Polysaccharide and Glycoconjugate Vaccines. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

   Google Scholar
8. 8.↵
   U.S. Pharmacopeial Convention, General Chapter <1046> Cell-Based Advanced Therapies and Tissue-Based Products. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

   Google Scholar
9. 9.↵
   U.S. Pharmacopeial Convention, General Chapter <1231> Water for Pharmaceutical Purposes. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

   Google Scholar
10. 10.↵
    U.S. Pharmacopeial Convention, Microbial Limit Tests. In USP 18—NF 13; USP: Rockville, MD, 1970; p 846.

    Google Scholar
11. 11.↵
    1. Price J.

    Establishing Microbiological Specifications for Pharmaceuticals Not Required to Be Sterile. Pharm. Manuf. 1984, April, 26–29.

    Google Scholar
12. 12.↵
    1. Kuhn R. J.,
    2. Lubin A. H.,
    3. Jones P. R.,
    4. Nahata M. C.

    Bacterial Contamination of Aerosol Solutions Used to Treat Cystic Fibrosis. Am. J. Hosp. Pharm. 1982, 39 (2), 308–309.

    OpenUrlPubMedGoogle Scholar
13. 13.↵
    1. Carson L. A.,
    2. Favero M. S.,
    3. Bond W. W.,
    4. Petersen N. J.

    Morphological, Biochemical, and Growth Characteristics of Pseudomonas cepacia from Distilled Water. Appl. Microbiol. 1973, 25 (3), 476–483.

    OpenUrlCrossRefPubMedWeb of ScienceGoogle Scholar
14. 14.↵
    1. Geftic S. G.,
    2. Heymann H.,
    3. Adair F. W.

    Fourteen-Year Survival of Pseudomonas cepacia in a Salts Solution Preserved with Benzalkonium Chloride. Appl. Environ. Microbiol. 1979, 37 (3), 505–510.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
15. 15.↵
    1. Anderson R. L.,
    2. Vess R. W.,
    3. Panlilio A. L.,
    4. Favero M. S.

    Prolonged Survival of Pseudomonas cepacia in Commercially Manufactured Povidone-Iodine. Appl. Environ. Microbiol. 1990, 56 (11), 3598–3600.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
16. 16.↵
    1. Hugo W. B.,
    2. Pallent L. J.,
    3. Grant D. J. W.,
    4. Denyer S. P.,
    5. Davies A.

    Factors Contributing to the Survival of a Strain of Pseudomonas cepacia in Chlorhexidine Solutions. Lett. Appl. Microbiol. 1986, 2 (3), 37–42.

    OpenUrlCrossRefGoogle Scholar
17. 17.↵
    1. Borovian G. E.

    Pseudomonas cepacia: Growth in and Adaptability to Increased Preservative Concentrations. J. Soc. Cosmet. Chem 1983, 34, 197–203.

    OpenUrlGoogle Scholar
18. 18.↵
    1. Richards R. M.,
    2. Richards J. M.

    Pseudomonas cepacia Resistance to Antibacterials. J. Pharm. Sci. 1979, 68 (11), 1436–1438.

    OpenUrlCrossRefPubMedGoogle Scholar
19. 19.↵
    U.S. Pharmacopeial Convention, General Chapter <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products. In USP 29—NF 24; USP: Rockville, MD, 2006; p 2969.

    Google Scholar
20. 20.↵
    U.S. Pharmacopeial Convention. Chapter <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. Pharm. Forum 2003, 29 (5), 1714–1722.

    OpenUrlGoogle Scholar
21. 21.↵
    U.S. Pharmacopeial Convention. Chapter <62> Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms. Pharm. Forum 2003, 29 (5), 1722–1733.

    OpenUrlGoogle Scholar
22. 22.↵
    U.S. Pharmacopeial Convention. Chapter <1111> Microbiological Quality of Nonsterile Pharmaceutical Products. Pharm. Forum 2003, 29 (5), 1733–1735.

    OpenUrlGoogle Scholar
23. 23.↵
    1. Hoenen I.,
    2. Bonnevay T.,
    3. Morris D.,
    4. Tirumalai R.

    A3P/AFI Survey on Sampling & Testing Practices for in-Process Pre-Filtration Bioburden for Sterile Products: Presentation of the Results & Critical Discussion. La Vague 2022, 74, 24–30.

    OpenUrlGoogle Scholar
24. 24.↵
    U.S. Pharmacopeial Convention, General Chapter <60> Microbiological Examination of Nonsterile Products: Tests for Burkholderia cepacia Complex. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

    Google Scholar
25. 25.↵
    U.S. Pharmacopeial Convention, General Chapter <1111> Microbiological Attributes of Nonsterile Pharmaceutical Products, Complex. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

    Google Scholar
26. 26.↵
    U.S. Pharmacopeial Convention, General Chapter <1227> Validation of Microbial Recovery from Pharmacopeial Articles. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

    Google Scholar
27. 27.↵
    U.S. Pharmacopeial Convention, General Chapter <1117> Microbiological Best Laboratory Practices. In USP—NF 2022, Issue 2; USP: Rockville, MD, 2022.

    Google Scholar
28. 28.↵
    1. Cundell T.,
    2. Tidswell E. C.,
    3. Massaro C.

    Live, Stressed and Dead Microorganisms—Their Role in Microbial Test Method Validation. Am. Pharm. Rev. 2021, 24 (2), 26–32.

    OpenUrlGoogle Scholar
29. 29.↵
    1. Guilfoyle D. E.,
    2. Cundell A. M.

    Do Plant Isolates Have a Role in Method Suitability and Growth Promotion Testing in the Microbiology Laboratory? Is It a Matter of Science versus Compliance? PDA J. Pharm. Sci. Technol. 2022, 76 (5), 444–460.

    OpenUrlAbstract/FREE Full TextGoogle Scholar
30. 30.↵
    ASTM International. ASTM D5465-93(1998) Standard Practice for Determining Microbial Colony Counts from Waters Analyzed by Plating Methods. ASTM: West Conshohocken, PA, 1998.

    Google Scholar
31. 31.↵
    U.S. Food and Drug Administration. Bacterial Analytical Manual. FDA Web site. https://www.fda.gov/food/laboratory-methods-food/bacteriological-analytical-manual-bam (accessed March 2024).

    Google Scholar
32. 32.↵
    1. Sutton S.

    Accuracy of Plate Counts, J. Validation Technol. 2010, 42-46.

    Google Scholar