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. INUllman’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 Technology.  29(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 View.  Controlled 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 TechnologySter 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 Testing.  Journal 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. Accuracy of Plate Counts Journal of Validation Technology 17(3):46-49 2011