Publications

  1. Correlation of the Genetic Map and the Endonuclease Site Map of Bacillus subtilis Bacteriophage SPO2; with S. Graham, Y. Yoneda, and F.E. Young. Journal of Virology42:131-134. 1982.
  2. Acid Tolerance, Proton Permeabilities, and Membrane ATPases of Oral Streptococci; with G.R. Bender and R.E. Marquis. Infection and Immunity53:331-338.  1986.
  3. Membrane associated and Solubilized ATPases of Streptococcus mutans and Streptococcus sanguis; with R.E. Marquis. Journal of Dental Research66:1095-1098. 1987.
  4. Fluoride Inhibition of Proton Translocating ATPases of Oral Bacteria; with Gary R. Bender and Robert E. Marquis. Infection and Immunity 55:2597-2603. 1987.
  5. A Spreadsheet for the Quantitative Validation of Direct Transfer Sterility Testing. Binary: Computers in Microbiology. 2:191-194. 1990.
  6. Neutralization Efficacy of Dey-Engley Media in Testing of Contact Lens Disinfecting Solutions; with Thomas Wrzosek and David W. Proud. Journal of Applied Bacteriology70:351-354. 1991.
  7. D-value Determinations Are an Inappropriate Measure of Disinfecting Activity of Common Contact Lens Disinfecting Solutions; with R.J. Franco, M.F. Mowrey McKee, S.C. Busschaert, J. Hamberger, and D.W. Proud. Applied and Environmental Microbiology57:2021-2026. 1991.
  8. “Ophthalmological Preparations” with T.M. Dolak, O.W. Lever, D. Marsh, and I. Moran. IN Ullman’s Encyclopedia of Industrial Chemistry vol. A 18 VCH Publ, Germany. pp. 127-151 1991.
  9. Development of a Universal Diluting Fluid for Membrane Filtration Sterility Testing; with David W. Proud.  Applied and Environmental Microbiology. 58:1035-1038. 1992.
  10. A Critical Evaluation of the Multi-item Microbial Challenge Test in Ophthalmic Disinfectant Testing; with D.W. Proud, H. Proskin and D.A. Keister.   The CLAO Journal. 18:155-160. 1992.
  11. The Importance of Neutralizer Evaluations in the Microbicidal Testing of Preservatives and Disinfecting Solutions. International Contact Lens Clinics. 19:167-173. 1992.
  12. The Relation Between Oral Pain and Ethanol Concentration in Mouthrinses; with S.J. Bolanowski and G.A. Gerscheider. Journal of Periodontal Research 30:192-197. 1995.
  13. “Neutralizer Evaluations as Control Experiments for Biocidal Efficacy Tests” IN Handbook of Disinfectants and Antiseptics, J.M. Ascenzi (ed.) Marcel Dekker, Inc., NY. pp. 43 – 62. 1996.
  14. “Antimicrobial Effects of Hydrogen Peroxide as an Antiseptic and Disinfectant”; with Andrea Lance, IN Handbook of Disinfectants and Antiseptics, J.M. Ascenzi (ed.) Marcel Dekker, Inc., NY. pp159 – 176. 1996.
  15. “Preservative Efficacy, Microbial Content, and Disinfectant Testing”; with Mary Anne Magee and Daniel K. Brannan, IN Cosmetic Microbiology, D.K. Brannan (ed.) Marcel Dekker, Inc., NY. 1997. p.95.
  16. In-use Shelf-Life Testing—What Data are Required and When?; with Brian Matthews and Danny Dunn. Regulatory Affairs Journal9:728-733. 1998.
  17. Activities of the USP Microbiology Subcommittee of Revision During the 1995—2000 Revision Cycle; with Joseph E. Knapp and Roger Dabbah.   PDA Journal of Science and Technology55(1):33-48. 2001
  18. The Role of USP in the Assessment of Microbiological Quality of Pharmaceuticals: A Five-Year Retrospective Leading to the Future; with Roger Dabbah and Joseph E. Knapp Pharmaceutical Technology North America25(7):54-61 2001
  19. Review of Standard for Evaluating the Effectiveness of Contact Lens Disinfectants with Ruth A. Rosenthal and Barry A. Schlech.  PDA Journal of Science and Technology56(1):37-52. 2002
  20. Developing an Information Chapter in the USP to Demonstrate Equivalency in Microbiological Methods with Joseph Knapp, Roger Dabbah and David Porter American Pharmaceutical Review 5(2):14-19.  2002.
  21. Validation of Microbial Recovery from Disinfectants; with David W. Proud, Stephen Rachui, and Daniel K. Brannan. PDA J of Science and Technology56(5):255-266. 2002.
  22. Development of the Antimicrobial Effectiveness Test as USP Chapter <51> with David Porter.   PDA J of Science and Technology. 56(6):300-311.   2002.
  23. The USP Perspective to Minimize the Potential Risk of TSE-infectivity in Bovine-derived Articles Used in the Manufacture of Medical Products; with Ian DeVeau and Roger Dabbah. Pharmacopeial Forum.30(5):1911-1921. 2004
  24. Microbial Identification in the Pharmaceutical Industry; with Anthony Cundell. Pharmacopeial Forum. 30(5):1884-1894. 2004
  25. Towards an Improved Sterility Test; with Jeanne Moldenhauer.  PDA J of Science and Technology 58(6):284-286. 2004.
  26. Validation of Alternate Microbiology Methods for Product Testing – Quantitative and Qualitative Assays. Pharmaceutical Technology29(4):118-122 Jan/Feb 2005.
  27. Activities of the USP Analytical Microbiology Committee of Experts During the 2000 – 2005 Revision Cycle with Joseph E. Knapp and David Porter.  PDA Journal of Science and Technology 59(3):157-176. 2005.
  28. Disinfectant Rotation—A Microbiologist’s ViewControlled Environments (formerly A2C2). 8(7):9-14. July, 2005
  29. “Cleanroom Microbiology”. IN Environmental Monitoring: A Comprehensive Handbook – Volume 1, J Moldenhauer (ed.) DHI Publications, Washington, DC. pp 97-118. 2005
  30. “Opportunities for the Pharmaceutical Industry”. IN Encyclopedia of Rapid Microbiological Methods – Volume 1, M. Miller (ed.) DHI Publications, Washington, DC. pp 123-156. 2005
  31. “Microbial Identification Systems”; with J. Moldenhauer. IN Environmental Monitoring: A Comprehensive Handbook – Volume 2, J. Moldenhauer (ed.) DHI Publications, Washington, DC. pp 281-296. 2006
  32. “Preservative Efficacy Testing and Microbial Content Testing”. IN Cosmetic Microbiology 2nd Ed, P. Geiss (ed.) Marcel Dekker, Inc., NY. pp. 111-145. 2006.
  33. Compendial Requirements for Automated Microbiological Method Validation: The Role of USP Chapter <16> “Automated Methods of Analysis” and the Proposed Chapter <1058> “Analytical Instrument Qualification” with David Jones PDA Newsletter42(6):23-26 2006.
  34. “Microbial Surface Monitoring”; IN Environmental Monitoring Anne Marie Dixon (ed) Informa Healthcare. 2006.
  35. The Harmonization of the Microbial Limits Tests; Pharmaceutical Technology30(12):66-73 2006.
  36. Is Real-Time-Release Through PAT Compatible with the Ideal of “Science-Based Regulation? Pharmaceutical Technology31(2):97-98. 2007
  37. “Disinfectant Rotation in a Cleaning/Disinfection Program for Clean Rooms and Controlled Environments”; IN Disinfection and Decontamination: Principles, Applications and Related Issues Gurusamy Manivannan (ed) Taylor and Francis 2007.
  38. Articles of Interest to the Microbiologist; PDA Letter 18(2):7-10. 2007
  39. Compounding of Sterile Medications in the Pharmacy – USP Chapter <797> Provides Guidance with David Porter Controlled Environments10(6):11-13. 2007
  40. Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics DHI Publishers, Inc. 2007
    Awarded PDA’s “Distinguished Author” for 2008
  41. “Microbiology and the Internet” INMicrobiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008
  42. “Global Harmonization of Microbiology-Related Compendial Chapters” IN Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008
  43. USP <1211>: The Compendial Informational Chapter on Sterility Assurance – Origins and Future Direction Pharmaceutical Technology Ster Manufact Suppl:s16-s21 2009
  44. Does International Harmonization of the USP Microbial Limits Tests Require Re-Validation of Finished Product Tests? Journal of Validation Technology15(3):10-16. 2009
  45. Hand Washing – A Critical Aspect of Personal Hygiene in Pharma Journal of Validation Technology15(4):50-55. 2009
  46. The International Harmonization of the Compendial Microbial Limits Tests- A Cautionary Tale of Compendial Participation Journal of GXP Compliance13(4):8-15 2009
  47. Limiting Avoidable Microbiological Variability Journal of Validation Technology16(1):50-56 2010
  48. Hand Washing, Hygiene, CGMP and Science Journal of GXP Compliance14(1):62-69 2010
  49. Qualification of an Environmental Monitoring Program Journal of Validation Technology 16(2):78-82 2010
  50. The Importance of a Strong SOP System in the QC Microbiology Lab Journal of GXP Compliance 14(2):44-52 2010
  51. The Most Probable Number Method and  Its Uses in Enumeration, Qualification and Validation Journal of Validation Technology 16(3):35-38 2010
  52. The Environmental Monitoring Program In a GMP Environment Journal of GXP Compliance 14(3):22-30 2010
  53. Qualification of a Contract Microbiology Laboratory Journal of Validation Technology 16(4):52-59 2010
  54. “The Compendial Sterility Tests”; IN Pharmaceutical Dosage Forms: Parenteral Medications, Third Edition Volume 2: Facility Design, Sterilization and Processing Sandeep Nema and John D. Ludwig, (ed) Informa Healthcare 2010
  55. The Most Probable Number Method and Its Use in QC Microbiology Journal of GXP Compliance 14(4):28-33 2010
  56. Laboratory Design:  Establishing the Facility and Management Structure.  DHI Publishers.  Editor.  2010
  57. The Role of Bioburden in the Contamination Control Plan pharmtech.com January 19, 2011
  58. Successful Use of a Contract Microbiology Laboratory Journal of GXP Compliance 15(1):54-64 2011
  59. Measurement of Microbial Cells by Optical Density Journal of Validation Technology 17(1):46-49 2011
  60. Successful Microbiological Investigations American Pharmaceutical Review 14(2):34-42   2011
  61. Microbiological Best Laboratory Practices, USP <1117> – Value and Recent Changes to a Guidance of Quality Laboratory Practice with Don Singer.  American Pharmaceutical Review 14(4):41-47  2011
  62. Determination of Inoculum for Microbiological TestingJournal of GXP Compliance 15(3):49-53 2011
  63. Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010 Revision Cycle.   American Pharmaceutical Review May/June pp 12-30  2011
  64. Contamination Control in the Compliance ProgramJournal of GXP Compliance 15(4):58-64  2011.   Awarded the Journal of GXP Compliance 2012 Paper of the Year
  65. Accuracy of Plate Counts Journal of Validation Technology 17(3):46-49 2011
  66. Qualification of a Microbial Identification System Journal of Validation Technology 17(4):46-49 2011
  67. Sterility Tests IN Rapid Sterility Testing J. Moldenhauer (ed) PDA/DHI Publ pp 7-24   2011
  68. A Review of Reported Recalls Involving Microbiological Control 2004-2011 with Emphasis on FDA Considerations of “Objectionable Organisms” with Luis Jimenez  American Pharmaceutical Review 15(1):42-57  2012
  69. Letter to the Editor in response to Torbeck, L et al., “Burkholderia cepacia: This Decision Is Overdue.”  PDA Journal of Pharmaceutical Science and Technology 66(2):91-95 2012    Note:  The original article (by Torbeck, et al) is here.
  70. Microbial Identification in a GXP Environment—Which System is Best? Journal of GXP Compliance 16(2):55-59 2012
  71. The Contamination Control Plan in Facility Validation Journal of Validation Technology 18(2):42-47  2012
  72. What is an “Objectionable Organism”? American Pharmaceutical Review 15(6):36-48 2012
  73. Environmental Monitoring Data Trending in the Aseptic Core – USP <1116> and “Contamination Recovery Rates” Journal of GXP Compliance 16(4):59-63  2012
  74. Aspects, Advantages and Disadvantages of Current Microbial Identification Systems:  A Multi-Component Approach to Identifications in the QC Microbiology Laboratory.  IN: Microbial Identifications Mary Griffin and Dona Reber (ed)  PDA/DHI Publ  2012