Sutton Publications

General Topics of Publication

Compounding Pharmacies

• Critical Components of Effective Environmental Monitoring  Pharmacy Purchasing & Products 12(3):20-24  2015
• Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: SCIENCE AND COMPLIANCE with A Grilli.  Intl J Pharm Compounding 19(1):30-37   2015
• Choosing a 503B Outsourcing Facility   Pharmacy Purchasing & Products 11(12):22-24  2014
• Qualification Studies of the Cleanroom for CSP Compounding New York State Pharmacist 88(4):22-23  2014
• Media Fill Simulations with A Connors  Manufacturing Chemist November 2014 Suppl  pp. IX-XI  2014
• FDA Expectations for 503B Outsourcing Facilities Pharmacy  Purchasing & Products 11(10):18-21 2014
• What are the Risks of Reusing Metered-Dose Inhalers? Pharmacy  Purchasing & Products 11(5):26 2014
• FDA, USP, and the 503B Outsourcing Facilities  J. GXP Compliance  18(2)
• Understanding the Role of Sterility Testing in Compounding  Pharmacy Purchasing & Products 11(3)28-29  2014
• GMP and Compounding Pharmacies American Pharmaceutical Review 16(3):48-59.  2013
• Compounding of Sterile Medications in the Pharmacy – USP Chapter <797> Provides Guidance with David Porter Controlled Environments  10(6):11-13. 2007

Contamination Control - Environmental Monitoring

• Trending in the Environmental Monitoring Program  American Pharmaceutical Review  in press
• Bioburden Contamination Control: A Holistic Overview  American Pharmaceutical Review Endotoxin Supplement July/August  pp. 20-24.  2015
• Critical Components of Effective Environmental Monitoring  Pharmacy Purchasing & Products 12(3):20-24  2015
• Agar Transfer Devices for Environmental Sampling in the Compounding PharmacyE with A Grilli.  Intl J Pharm Compounding 19(1):30-37   2015
• Media Fill Simulations with A Connors  Manufacturing Chemist November 2014 Suppl  pp. IX-XI  2014
• The Contamination Control Plan in Facility Validation IN: Contamination Control in Healthcare Product Manufacturing RE Madsen and J Moldenhauer (ed) PDA/DHI Publications pp. 7-30  2013
  
• USP <1116> and Contamination Recovery Rates  Journal of Validation Technology 18(4)79-83.  2012
• Environmental Monitoring Data Trending in the Aseptic Core – USP <1116> and “Contamination Recovery Rates” Journal of GXP Compliance 16(4):59-63  2012
• The Contamination Control Plan in Facility Validation Journal of Validation Technology 18(2):42-47  2012
• Contamination Control in the Compliance Program.  Journal of GXP Compliance 15(4):58-64  2011.   Awarded the Journal of GXP Compliance 2012 Paper of the Year
• Successful Microbiological Investigations American Pharmaceutical Review 14(2):34-42   2011
• The Role of Bioburden in the Contamination Control Plan pharmtech.com January 19, 2011
• The Environmental Monitoring Program In a GMP Environment Journal of GXP Compliance 14(3):22-30 2010
• Qualification of an Environmental Monitoring Program Journal of Validation Technology 16(2):78-82 2010
• Hand Washing, Hygiene, CGMP and Science Journal of GXP Compliance  14(1):62-69 2010
• USP <1211>: The Compendial Informational Chapter on Sterility Assurance – Origins and Future Direction Pharmaceutical Technology Ster Manufact Suppl:s16-s21 2009
• Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics DHI Publishers, Inc. 2007
  Awarded PDA’s “Distinguished Author” for 2008
• “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.
• Is Real-Time-Release Through PAT Compatible with the Ideal of “Science-Based Regulation? Pharmaceutical Technology 31(2):97-98. 2007
• 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 Newsletter  42(6):23-26 2006.
• “Microbial Surface Monitoring”; IN Environmental Monitoring Anne Marie Dixon (ed) Informa Healthcare. 2006.
• “Microbial Identification Systems”; with J. Moldenhauer. IN Environmental Monitoring: A Comprehensive
• “Cleanroom Microbiology”. IN Environmental Monitoring: A Comprehensive Handbook – Volume 1, J Moldenhauer (ed.) DHI Publications, Washington, DC. pp 97-118. 2005
• Disinfectant Rotation—A Microbiologist’s View.  Controlled Environments (formerly A2C2). 8(7):9-14. July, 2005
• 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 25(7):54-61 2001

Objectionable Organisms

• Recovery of Stressed (Acclimated) Burkholderia cepacia Complex Organisms American Pharmaceutical Review 17(3):16-24 2014  with Julie Barlasov and Richard Jakober
• Implications of the Human Microbiome on Pharmaceutical Microbiology American Pharmaceutical Review 16(5):17-21 with Cara Wilder and Tim Sandle  2013
• What is an “Objectionable Organism”? American Pharmaceutical Review 15(6):36-48 2012
•  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.
• 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
• The International Harmonization of the Compendial Microbial Limits Tests- A Cautionary Tale of Compendial Participation Journal of GXP Compliance  13(4):8-15 2009
• The Harmonization of the Microbial Limits Tests Pharmaceutical Technology  30(12):66-73 2006.

QC Microbiology Testing

• Recovery of Stressed (Acclimated) Burkholderia cepacia Complex Organisms American Pharmaceutical Review 17(3):16-24 2014  with Julie Barlasov and Richard Jakober
• Understanding the Role of Sterility Testing in Compounding  Pharmacy Purchasing & Products 11(3)28-29  2014
• The Antimicrobial Efficacy Test, GMP and Investigations  American Pharmaceutical Review 16(5):40-48 2013
• Method Suitability Control Studies for Microbial Testing: Quantitative Comparisons. Journal of Validation Technology 17(2)   2013
  
• Microbial Identification in a GXP Environment—Which System is Best? Journal of GXP Compliance 16(2):55-59 2012
• Sterility Tests IN Rapid Sterility Testing J. Moldenhauer (ed) PDA/DHI Publ pp 7-24   2011
• Accuracy of Plate Counts Journal of Validation Technology 17(3):46-49 2011
• Determination of Inoculum for Microbiological Testing .  Journal of GXP Compliance 15(3):49-53 2011
• Successful Microbiological Investigations American Pharmaceutical Review 14(2):34-42   2011
• Measurement of Microbial Cells by Optical Density Journal of Validation Technology 17(1):46-49 2011
• The Most Probable Number Method and Its Use in QC Microbiology Journal of GXP Compliance 14(4):28-33 2010
• “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
• The Most Probable Number Method and  Its Uses in Enumeration, Qualification and Validation Journal of Validation Technology 16(3):35-38 2010
• Limiting Avoidable Microbiological Variability Journal of Validation Technology  16(1):50-56 2010
• The International Harmonization of the Compendial Microbial Limits Tests- A Cautionary Tale of Compendial Participation Journal of GXP Compliance  13(4):8-15 2009
• Does International Harmonization of the USP Microbial Limits Tests Require Re-Validation of Finished Product Tests? Journal of Validation Technology 15(3):10-16. 2009
• “Global Harmonization of Microbiology-Related Compendial Chapters” IN Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008
• Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics DHI Publishers, Inc. 2007
  Awarded PDA’s “Distinguished Author” for 2008
• The Harmonization of the Microbial Limits Tests Pharmaceutical Technology  30(12):66-73 2006.
• “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
• Validation of Alternate Microbiology Methods for Product Testing – Quantitative and Qualitative Assays. Pharmaceutical Technology.  29(4):118-122 Jan/Feb 2005.
• Towards an Improved Sterility Test; with Jeanne Moldenhauer.  PDA J of Science and Technology 58(6):284-286. 2004.
• Microbial Identification in the Pharmaceutical Industry; with Anthony Cundell. Pharmacopeial Forum. 30(5):1884-1894. 2004
• Development of the Antimicrobial Effectiveness Test as USP Chapter <51> with David Porter.   PDA J of Science and Technology. 56(6):300-311.   2002.
• Validation of Microbial Recovery from Disinfectants; with David W. Proud, Stephen Rachui, and Daniel K. Brannan. PDA J of Science and Technology  56(5):255-266. 2002.
• 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.
• Review of Standard for Evaluating the Effectiveness of Contact Lens Disinfectants with Ruth A. Rosenthal and Barry A. Schlech.  PDA Journal of Science and Technology  56(1):37-52. 2002
• 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 25(7):54-61 2001
• In-use Shelf-Life Testing—What Data are Required and When?; with Brian Matthews and Danny Dunn. Regulatory Affairs Journal  9:728-733. 1998.
• “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.
• “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.
• “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.
• The Importance of Neutralizer Evaluations in the Microbicidal Testing of Preservatives and Disinfecting Solutions. International Contact Lens Clinics. 19:167-173. 1992.
• 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.
• Development of a Universal Diluting Fluid for Membrane Filtration Sterility Testing; with David W. Proud.  Applied and Environmental Microbiology. 58:1035-1038. 1992.
• 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 Microbiology  57:2021-2026. 1991.
• 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.
• A Spreadsheet for the Quantitative Validation of Direct Transfer Sterility Testing; Binary: Computers in Microbiology. 2:191-194. 1990.

QC Microbiology Lab Operations

• QC Microbiology, GMP and Social Media:  Results of an Industry Survey Journal Validation Technology  17(2)   2013
• Qualification of a Microbial Identification System Journal of Validation Technology 17(4):46-49 2011
• Accuracy of Plate Counts Journal of Validation Technology 17(3):46-49 2011
• Determination of Inoculum for Microbiological Testing .  Journal of GXP Compliance 15(3):49-53 2011
• 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
• Successful Microbiological Investigations American Pharmaceutical Review 14(2):34-42   2011
• Measurement of Microbial Cells by Optical Density Journal of Validation Technology 17(1):46-49 2011
• Successful Use of a Contract Microbiology LaboratoryJournal of GXP Compliance 15(1):54-64 2011
• Laboratory Design:  Establishing the Facility and Management Structure.  DHI Publishers.  Editor.  2010
• The Most Probable Number Method and Its Use in QC Microbiology Journal of GXP Compliance 14(4):28-33 2010
• Qualification of a Contract Microbiology Laboratory Journal of Validation Technology 16(4):52-59 2010
• The Environmental Monitoring Program In a GMP Environment Journal of GXP Compliance 14(3):22-30 2010
• The Most Probable Number Method and  Its Uses in Enumeration, Qualification and Validation Journal of Validation Technology 16(3):35-38 2010
• The Importance of a Strong SOP System in the QC Microbiology Lab Journal of GXP Compliance 14(2):44-52 2010
• Qualification of an Environmental Monitoring Program Journal of Validation Technology 16(2):78-82 2010
• Hand Washing, Hygiene, CGMP and Science Journal of GXP Compliance  14(1):62-69 2010
• Limiting Avoidable Microbiological Variability Journal of Validation Technology  16(1):50-56 2010
• “Microbiology and the Internet” IN: Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008
• Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics DHI Publishers, Inc. 2007
  Awarded PDA’s “Distinguished Author” for 2008
• Is Real-Time-Release Through PAT Compatible with the Ideal of “Science-Based Regulation? Pharmaceutical Technology 31(2):97-98. 2007
• 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 Newsletter  42(6):23-26 2006.
• “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
• “Preservative Efficacy Testing and Microbial Content Testing”. IN: Cosmetic Microbiology 2nd Ed, P. Geiss (ed.) Marcel Dekker, Inc., NY. pp. 111-145. 2006.
• “Cleanroom Microbiology”. IN Environmental Monitoring: A Comprehensive Handbook – Volume 1, J Moldenhauer (ed.) DHI Publications, Washington, DC. pp 97-118. 2005
• “Opportunities for the Pharmaceutical Industry”. IN:  Encyclopedia of Rapid Microbiological Methods – Volume 1, M. Miller (ed.) DHI Publications, Washington, DC. pp 123-156. 2005
• Disinfectant Rotation—A Microbiologist’s View.  Controlled Environments (formerly A2C2). 8(7):9-14. July, 2005
• Validation of Alternate Microbiology Methods for Product Testing – Quantitative and Qualitative Assays. Pharmaceutical Technology.  29(4):118-122 Jan/Feb 2005.
• Microbial Identification in the Pharmaceutical Industry; with Anthony Cundell. Pharmacopeial Forum. 30(5):1884-1894. 2004
• Validation of Microbial Recovery from Disinfectants; with David W. Proud, Stephen Rachui, and Daniel K. Brannan. PDA J of Science and Technology  56(5):255-266. 2002.
• 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.
• Review of Standard for Evaluating the Effectiveness of Contact Lens Disinfectants with Ruth A. Rosenthal and Barry A. Schlech.  PDA Journal of Science and Technology  56(1):37-52. 2002
• In-use Shelf-Life Testing—What Data are Required and When?; with Brian Matthews and Danny Dunn. Regulatory Affairs Journal  9:728-733. 1998.
• “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.
• “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.
• “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.
• 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.
• The Importance of Neutralizer Evaluations in the Microbicidal Testing of Preservatives and Disinfecting Solutions. International Contact Lens Clinics. 19:167-173. 1992.
• 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.
• Development of a Universal Diluting Fluid for Membrane Filtration Sterility Testing; with David W. Proud.  Applied and Environmental Microbiology. 58:1035-1038. 1992.
• “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.
• 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 Microbiology  57:2021-2026. 1991.
• 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.
• A Spreadsheet for the Quantitative Validation of Direct Transfer Sterility Testing; Binary: Computers in Microbiology. 2:191-194. 1990.

USP

• FDA, USP, and the 503B Outsourcing Facilities  J. GXP Compliance  18(2)
• Understanding the Role of Sterility Testing in Compounding  Pharmacy Purchasing & Products 11(3)28-29  2014
• The Antimicrobial Efficacy Test, GMP and Investigations  American Pharmaceutical Review 16(5):40-48 2013
• USP <1116> and Contamination Recovery Rates  Journal of Validation Technology 18(4)79-83.  2012
• Environmental Monitoring Data Trending in the Aseptic Core – USP <1116> and “Contamination Recovery Rates” Journal of GXP Compliance 16(4):59-63  2012
  
• Sterility Tests IN Rapid Sterility Testing J. Moldenhauer (ed) PDA/DHI Publ pp 7-24   2011
• Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010 Revision Cycle with Radhakrishna Tirumalai.  American Pharmaceutical Review May/June pp 12-30  2011
• 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
• The International Harmonization of the Compendial Microbial Limits Tests- A Cautionary Tale of Compendial Participation Journal of GXP Compliance  13(4):8-15 2009
• Does International Harmonization of the USP Microbial Limits Tests Require Re-Validation of Finished Product Tests? Journal of Validation Technology 15(3):10-16. 2009
• USP <1211>: The Compendial Informational Chapter on Sterility Assurance – Origins and Future
  
• Compounding of Sterile Medications in the Pharmacy – USP Chapter <797> Provides Guidance with David Porter Controlled Environments  10(6):11-13. 2007
• The Harmonization of the Microbial Limits Tests Pharmaceutical Technology  30(12):66-73 2006.
• 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 Newsletter  42(6):23-26 2006.
• 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.
• Validation of Alternate Microbiology Methods for Product Testing – Quantitative and Qualitative Assays. Pharmaceutical Technology.  29(4):118-122 Jan/Feb 2005.
• Towards an Improved Sterility Test; with Jeanne Moldenhauer.  PDA J of Science and Technology 58(6):284-286. 2004.
• 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
• Development of the Antimicrobial Effectiveness Test as USP Chapter <51> with David Porter.   PDA J of Science and Technology. 56(6):300-311.   2002.
• 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.
• 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 25(7):54-61 2001
• 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 Technology  55(1):33-48. 2001
• A Spreadsheet for the Quantitative Validation of Direct Transfer Sterility Testing; Binary: Computers in Microbiology. 2:191-194. 1990.

All

1. Trending in the Environmental Monitoring Program  American Pharmaceutical Review  in press
2. Bioburden Contamination Control: A Holistic Overview  American Pharmaceutical Review Endotoxin Supplement July/August  pp. 20-24.  2015
3. Critical Components of Effective Environmental Monitoring  Pharmacy Purchasing & Products 12(3):20-24  2015
4. Agar Transfer Devices for Environmental Sampling in the Compounding Pharmacy: SCIENCE AND COMPLIANCE with A Grilli.  Intl J Pharm Compounding 19(1):30-37   2015
5. Critical Analysis of Common Canister Programs: A Review of Cross-functional Considerations and Health System Economics with Larson, T., R. Gudavalli and D. Prater  Current Medical Research & Opinion    Article FT-0471.R1/1016604   2015
6. Choosing a 503B Outsourcing Facility   Pharmacy Purchasing & Products 11(12):22-24  2014
7. Qualification Studies of the Cleanroom for CSP Compounding New York State Pharmacist 88(4):22-23  2014
8. Media Fill Simulations with A Connors  Manufacturing Chemist November 2014 Suppl  pp. IX-XI  2014
9. FDA Expectations for 503B Outsourcing Facilities Pharmacy  Purchasing & Products 11(10):18-21 2014
10. What are the Risks of Reusing Metered-Dose Inhalers? Pharmacy  Purchasing & Products 11(5):26 2014
11. FDA, USP and Compounding Manufacturers (Outsourcing Facilities) Journal of GXP Compliance 18(2) 2014
12. Recovery of Stressed (Acclimated) Burkholderia cepacia Complex Organisms American Pharmaceutical Review 17(3):16-24 2014  with Julie Barlasov and Richard Jakober
13. FDA, USP, and the 503B Outsourcing Facilities  J. GXP Compliance  18(2)
14. Understanding the Role of Sterility Testing in Compounding  Pharmacy Purchasing & Products 11(3)28-29  2014
15. Implications of the Human Microbiome on Pharmaceutical Microbiology American Pharmaceutical Review 16(5):17-21 with Cara Wilder and Tim Sandle  2013
16. The Antimicrobial Efficacy Test, GMP and Investigations  American Pharmaceutical Review 16(5):40-48 2013
17. QC Microbiology, GMP and Social Media:  Results of an Industry Survey Journal Validation Technology  17(2)   2013
18. Implications of the Human Microbiome on Pharmaceutical Microbiology American Pharmaceutical Review June 25, 2013 with Cara Wilder and Tim Sandle  ONLINE BLOG
19. The Contamination Control Plan in Facility Validation IN: Contamination Control in Healthcare Product Manufacturing RE Madsen and J Moldenhauer (ed) PDA/DHI Publications pp. 7-30  2013
    
20. Method Suitability Control Studies for Microbial Testing: Quantitative Comparisons. Journal of Validation Technology 17(2)   2013
    
21. GMP and Compounding Pharmacies American Pharmaceutical Review 16(3):48-59.  2013
22. USP <1116> and Contamination Recovery Rates  Journal of Validation Technology 18(4)79-83.  2012
23. 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
24. Environmental Monitoring Data Trending in the Aseptic Core – USP <1116> and “Contamination Recovery Rates” Journal of GXP Compliance 16(4):59-63  2012
    
25. What is an “Objectionable Organism”? American Pharmaceutical Review 15(6):36-48 2012
26. The Contamination Control Plan in Facility Validation Journal of Validation Technology 18(2):42-47  2012
27. Microbial Identification in a GXP Environment—Which System is Best? Journal of GXP Compliance 16(2):55-59 2012
28.  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.
29. 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
30. Sterility Tests IN Rapid Sterility Testing J. Moldenhauer (ed) PDA/DHI Publ pp 7-24   2011
31. Qualification of a Microbial Identification System Journal of Validation Technology 17(4):46-49 2011
32. Accuracy of Plate Counts Journal of Validation Technology 17(3):46-49 2011
33. Contamination Control in the Compliance Program.  Journal of GXP Compliance 15(4):58-64  2011.   Awarded the Journal of GXP Compliance 2012 Paper of the Year
34. Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005–2010 Revision Cycle with Radhakrishna Tirumalai.  American Pharmaceutical Review May/June pp 12-30  2011
35. Determination of Inoculum for Microbiological Testing .  Journal of GXP Compliance 15(3):49-53 2011
36. 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
37. Successful Microbiological Investigations American Pharmaceutical Review 14(2):34-42   2011
38. Measurement of Microbial Cells by Optical Density Journal of Validation Technology 17(1):46-49 2011
39. Successful Use of a Contract Microbiology LaboratoryJournal of GXP Compliance 15(1):54-64 2011
40. The Role of Bioburden in the Contamination Control Plan pharmtech.com January 19, 2011
41. Laboratory Design:  Establishing the Facility and Management Structure.  DHI Publishers.  Editor.  2010
42. The Most Probable Number Method and Its Use in QC Microbiology Journal of GXP Compliance 14(4):28-33 2010
43. “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
44. Qualification of a Contract Microbiology Laboratory Journal of Validation Technology 16(4):52-59 2010
45. The Environmental Monitoring Program In a GMP Environment Journal of GXP Compliance 14(3):22-30 2010
46. The Most Probable Number Method and  Its Uses in Enumeration, Qualification and Validation Journal of Validation Technology 16(3):35-38 2010
47. The Importance of a Strong SOP System in the QC Microbiology Lab Journal of GXP Compliance 14(2):44-52 2010
48. Qualification of an Environmental Monitoring Program Journal of Validation Technology 16(2):78-82 2010
49. Hand Washing, Hygiene, CGMP and Science Journal of GXP Compliance  14(1):62-69 2010
50. Limiting Avoidable Microbiological Variability Journal of Validation Technology  16(1):50-56 2010
51. The International Harmonization of the Compendial Microbial Limits Tests- A Cautionary Tale of Compendial Participation Journal of GXP Compliance  13(4):8-15 2009
52. Hand Washing – A Critical Aspect of Personal Hygiene in Pharma Journal of Validation Technology  15(4):50-55. 2009
53. Does International Harmonization of the USP Microbial Limits Tests Require Re-Validation of Finished Product Tests? Journal of Validation Technology 15(3):10-16. 2009
54. USP <1211>: The Compendial Informational Chapter on Sterility Assurance – Origins and Future Direction Pharmaceutical Technology Ster Manufact Suppl:s16-s21 2009
55. “Microbiology and the Internet” IN: Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008
56. “Global Harmonization of Microbiology-Related Compendial Chapters” IN Microbiology in Pharmaceutical Manufacturing 2nd Ed Richard Prince (ed) DHI Publ 2008
57. Pharmaceutical Quality Control Microbiology: A Guidebook to the Basics DHI Publishers, Inc. 2007
    Awarded PDA’s “Distinguished Author” for 2008
58. Compounding of Sterile Medications in the Pharmacy – USP Chapter <797> Provides Guidance with David Porter Controlled Environments  10(6):11-13. 2007
59. “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.
60. Articles of Interest to the Microbiologist PDA Letter 18(2):7-10. 2007
61. Is Real-Time-Release Through PAT Compatible with the Ideal of “Science-Based Regulation? Pharmaceutical Technology 31(2):97-98. 2007
62. The Harmonization of the Microbial Limits Tests Pharmaceutical Technology  30(12):66-73 2006.
63. “Microbial Surface Monitoring”; IN Environmental Monitoring Anne Marie Dixon (ed) Informa Healthcare. 2006.
64. 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 Newsletter  42(6):23-26 2006.
65. “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
66. “Preservative Efficacy Testing and Microbial Content Testing”. IN: Cosmetic Microbiology 2nd Ed, P. Geiss (ed.) Marcel Dekker, Inc., NY. pp. 111-145. 2006.
67. “Cleanroom Microbiology”. IN Environmental Monitoring: A Comprehensive Handbook – Volume 1, J Moldenhauer (ed.) DHI Publications, Washington, DC. pp 97-118. 2005
68. “Opportunities for the Pharmaceutical Industry”. IN:  Encyclopedia of Rapid Microbiological Methods – Volume 1, M. Miller (ed.) DHI Publications, Washington, DC. pp 123-156. 2005
69. Disinfectant Rotation—A Microbiologist’s View.  Controlled Environments (formerly A2C2). 8(7):9-14. July, 2005
70. 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.
71. Validation of Alternate Microbiology Methods for Product Testing – Quantitative and Qualitative Assays. Pharmaceutical Technology.  29(4):118-122 Jan/Feb 2005.
72. Towards an Improved Sterility Test; with Jeanne Moldenhauer.  PDA J of Science and Technology 58(6):284-286. 2004.
73. Microbial Identification in the Pharmaceutical Industry; with Anthony Cundell. Pharmacopeial Forum. 30(5):1884-1894. 2004
74. 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
75. Development of the Antimicrobial Effectiveness Test as USP Chapter <51> with David Porter.   PDA J of Science and Technology. 56(6):300-311.   2002.
76. Validation of Microbial Recovery from Disinfectants; with David W. Proud, Stephen Rachui, and Daniel K. Brannan. PDA J of Science and Technology  56(5):255-266. 2002.
77. 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.
78. Review of Standard for Evaluating the Effectiveness of Contact Lens Disinfectants with Ruth A. Rosenthal and Barry A. Schlech.  PDA Journal of Science and Technology  56(1):37-52. 2002
79. 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 25(7):54-61 2001
80. 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 Technology  55(1):33-48. 2001
81. In-use Shelf-Life Testing—What Data are Required and When?; with Brian Matthews and Danny Dunn. Regulatory Affairs Journal  9:728-733. 1998.
82. “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.
83. “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.
84. “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.
85. 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.
86. The Importance of Neutralizer Evaluations in the Microbicidal Testing of Preservatives and Disinfecting Solutions. International Contact Lens Clinics. 19:167-173. 1992.
87. 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.
88. Development of a Universal Diluting Fluid for Membrane Filtration Sterility Testing; with David W. Proud.  Applied and Environmental Microbiology. 58:1035-1038. 1992.
89. “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.
90. 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 Microbiology  57:2021-2026. 1991.
91. 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.
92. A Spreadsheet for the Quantitative Validation of Direct Transfer Sterility Testing; Binary: Computers in Microbiology. 2:191-194. 1990.
93. Fluoride Inhibition of Proton Translocating ATPases of Oral Bacteria; with Gary R. Bender and Robert E. Marquis. Infection and Immunity 55:2597-2603. 1987.
94. Membrane associated and Solubilized ATPases of Streptococcus mutans and Streptococcus sanguis; with R.E. Marquis. Journal of Dental Research  66:1095-1098. 1987.
95. Acid Tolerance, Proton Permeabilities, and Membrane ATPases of Oral Streptococci; with G.R. Bender and R.E. Marquis. Infection and Immunity  53:331-338.  1986.
96. 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 Virology  42:131-134. 1982.