Useful links
References that can be viewed or downloaded will have a blue link in their title. When you click on the link the document will appear in a new window, or you will be redirected to an external website where the reference may be viewed or purchased.
Reference Categories: Regulatory Guidance, Validation Strategies, Economics and Return on Investment, Applications and Methods, RMM Technologies, Quality and General Overviews and Books.
2012. Federal Register. Food and Drug Administration. Amendments to Sterility Test Requirements for Biological Products Final Rule . 21 CFR Parts 600, 610, and 680 [Docket No. FDA–2011–N–0080]. 77(86): 26162-26175.
2012. Miller, M.J. Rapid Micro Methods and EMA’s Post Approval Change Management Protocol. European Pharmaceutical Review. 17(2): 65-67.
2011. Riley, B. A Regulators View of Rapid Microbiology Methods. European Pharmaceutical Review. 16(5): 59-61.
2011. Food and Drug Administration. Advancing Regulatory Science at FDA. A Strategic Plan. U.S. Department of Health and Human Services, Rockville, Maryland.
2011. Federal Register. Food and Drug Administration. Amendments to Sterility Test Requirements for Biological Products. Proposed Rule. 21 CFR Parts 600, 610, and 680 [Docket No. FDA–2011–N–0080]. 76(119): 36019-36027.
2010. Miller, M.J. Microbiology Series. Article 4: The Implementation of Rapid Microbiological Methods (EMA Perspectives). European Pharmaceutical Review. 15(4): 17-19.
2010. Miller, M.J. Microbiology Series. Article 3: The Implementation of Rapid Microbiological Methods (FDA Perspectives). European Pharmaceutical Review. 15(3): 18-21.
2010. EMA. Post-Authorisation Procedural Advice Human Medicinal Products. Committee for Human Medicinal Products (CHMP). European Medicines Agency. EMEA-H-19984/03 Rev 16.
2009. ICH. Q8: Pharmaceutical Development. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Q8 (R2), Current Step 4 version.
2008. ICH. Q10: Pharmaceutical Quality System. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Q10, Current Step 4 version.
2008. Food and Drug Administration. Draft Guidance for Industry. Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products. U.S. Department of Health and Human Services, Rockville, Maryland.
2008. European Commission. EU guidelines to good manufacturing practice, Annex 1. Manufacture of sterile medicinal products. EudraLex, European Union: Brusselles, Belgium.
2008. Moldenhauer, J. A case for regulatory guidelines for verifying automated microbiological methods. American Pharmaceutical Review. 11(5): 36-43.
2005. ICH. Q9: Quality Risk Management. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Q9, Current Step 4 version.
2005. EMA. Quality of medicines Q&A: Part 2. Water - Microbiological Control of Water. Joint CHMP/CVMP Quality Working Party, European Medicines Agency.
2005. Miller, M.J. Rapid Microbiological Methods and FDA's Initiatives for Process Analytical Technology and Pharmaceutical cGMPs for the 21st Century: A Risk Based-Approach. American Pharmaceutical Review. 8(1): 104-107.
2005. Moldenhauer, J. Rapid microbiological methods and the PAT initiative. BioPharm International.
2004. Food and Drug Administration. Final report for pharmaceutical cGMPs for the 21st Century - A risk-based approach. U.S. Department of Health and Human Services, Rockville, Maryland.
2004. Food and Drug Administration. Guidance for industry: PAT - A framework for innovative pharmaceutical development, manufacturing, and quality assurance. U.S. Department of Health and Human Services, Rockville, Maryland.
2004. Food and Drug Administration. Guidance for industry: Sterile drug products produced by aseptic processing -Current good manufacturing practice. U.S. Department of Health and Human Services, Rockville, Maryland.
2003. Food and Drug Administration. Guidance for industry: Comparability Protocols - Protein Drug Products and Biological Products, Chemistry, Manufacturing, and Controls Information. U.S. Department of Health and Human Services, Rockville, Maryland.
2010. Duguid, J. Top Ten Validation Considerations When Implementing a Rapid Mycoplasma Test. American Pharmaceutical Review. 13(4): 26-31.
2010. Miller, M.J. Developing a validation strategy for rapid microbiological methods. American Pharmaceutical Review. 13(3): 28-33.
2010. Miller, M.J.; Moldenhauer, J. Revision of Technical Report #33. American Pharmaceutical Review. 13(1): 86-91.
2009. USP 32-NF27. General Information Chapter <1223>, Validation of alternative microbiological methods. U.S. Pharmacopeial Convention, Rockville, Maryland.
2009. European Pharmacopoeia 6.4. Informational chapter 5.1.6. Alternative methods for control of microbiological quality. European Directorate for the Quality of Medicines (EDQM), Strasbourg, France.
2008. Newby, P. Implementation, validation and registration of rapid microbiological methods. European Pharmaceutical Review. 13(3): 67-73.
2007. Green, S. Industry strategy case study E: How to select, validate, and implement a rapid microbiology method and get it approved - A true story. American Pharmaceutical Review. 10(5): 102-107.
2005. Sutton, S. Validation of Alternative Microbiology Methods for Product Testing: Quantitative and Qualitative Assays. Pharmaceutical Technology. 29(4): 118-122.
2005. Newby, P. Implementation, validation and registration. European Pharmaceutical Review. 10(2): 92-95.
2004. Newby, P.J. Implementation, validation and registration of rapid microbiological methods. American Pharmaceutical Review. 7(4): 10-15.
2000. PDA. Technical Report #33. Evaluation, Validation and Implementation of New Microbiological Testing Methods. PDA Journal of Pharmaceutical Science and Technology. Supplement 54(3). Parenteral Drug Association, Bethesda, Maryland.
2009. Miller, M.J. Rapid microbiological methods and demonstrating a return on investment: It's easier than you think! American Pharmaceutical Review. 12(5): 42-47.
2009. Gadal, P.; Yvon, P. Rapid Microbio ROI - Calculating scientific benefits as return on investment dollars. Pharmaceutical Formulation & Quality. 11(3): 44-47.
2009. Miller, M.J. Ensuring ROI from your RMM. Pharmaceutical Manufacturing. 8(6): 32-35.
2009. Miller, M.J. Quality Risk Management and the Economics of Implementing Rapid Microbiological Methods. European Pharmaceutical Review. 2: 66-73.
2006. Ghandi, M. Efficiency with Rapid Microbiology Methods. American Pharmaceutical Review. 9(5): 16-19.
2012. Jimenez, L.; Rana, N.; Amalraj, J.; Walker, K.; Travers, K. Validation of the BacT/ALERT 3D System for Rapid Sterility Testing of Biopharmaceutical Samples. PDA Journal of Pharmaceutical Science and Technology. 66(1): 38.54.
2011. Miller, M.J. QbD, PAT, and the Future of Microbiology. Environmental monitoring with RMM. Contract Pharma. 13(4): 70-73.
2011. Jimenez, L. Molecular Applications to Pharmaceutical Processes and Cleanroom Environments. PDA Journal of Pharmaceutical Science and Technology. 65(3): 242-253.
2011. Gray, J.C.; Morandell, D.; Gapp, G.; Le Goff, N.; Neuhaus, G.; Staerk, A. Identification of Micro-Organisms after Milliflex Rapid Detection—A Possibility To Identify Nonsterile Findings in the Milliflex Rapid Sterility Test. PDA Journal of Pharmaceutical Science and Technology. 65(1): 42-54.
2011. Gordon, O.; Gray, J.C.; Anders, H.J.; Staerk, A.; Schlaefli, O.; Neuhaus, G. Overview of Rapid Microbiological Methods Evaluated, validated and Implemented for Microbiological Quality Control. European Pharmaceutical Review. 16(2): 9-13.
2010. Sampath, R., Blyn, L.B.; Ecker, D.J. Rapid Molecular Assays for Microbial Contaminant Monitoring in the Bioprocess Industry. PDA Journal of Pharmaceutical Science and Technology. 64(5): 458-464.
2010. Gray, J.C.; Staerk, A.; Berchtold, M.; Mercier, M.; Neuhaus, G.; Wirth, A. Introduction of a Rapid Microbiological Method as an Alternative to the Pharmacopoeial Method for the Sterility Test. American Pharmaceutical Review. 13(6): 88-94.
2010. McIver, D. Using RMM for Environmental Monitoring. Pharmaceutical Manufacturing. 9(7): 37-38.
2010. Gray, J.C.; Staerk, A.; Berchtold, M.; Hecker, W.; Neuhaus, G.; Wirth, A. Growth-promoting Properties of Different Solid Nutrient Media Evaluated with Stressed and Unstressed Micro-organisms: Prestudy for the Validation of a Rapid Sterility Test. PDA Journal of Pharmaceutical Science and Technology. 64(3): 249-263.
2010. Denoya, C.; Sessions, D.; Shabushnig, J. A Rapid Microbiological Assay to Monitor the Effectiveness of a Vaccine Injector Sanitization Following a Microbial Challenge Procedure. American Pharmaceutical Review. 13(4): 54-61.
2009. Williams , K.L. The BET as a Backdrop for Establishing PAT and RMM Goals. American Pharmaceutical Review. 12(7): 42-47.
2009. Duguid, J.; Kielpinski, G.; Seymour, B.; du Moulin, G. Risk Assessment for a Rapid Mycoplasma Test Optimized for Cell Therapy Products. American Pharmaceutical Review. 12(6): 100-104.
2009. Bagur, E. Concurrent Evaluation of both Compendial and Rapid Methods (ATP Bioluminescence) for Monitoring Water Quality in Pharmaceutical Manufacturing. European Pharmaceutical Review. 14(3): 58-68.
2008. Gressett, G.; Vanhaecke, E.; Moldenhauer, J. Why and how to implement a rapid sterility test. PDA Journal of Pharmaceutical Science and Technology. 62(6): 429-444.
2007. McDaniel, A. Microbial Detection in Mammalian Cell Culture Systems. American Pharmaceutical Review, 10(1): 24-29.
2007. Anders, H-J.; Keller, M.; berchtold, M.; Hecker, W. Polyphasic approach to microbial identification. American Pharmaceutical Review. 10(6): 46-52.
2006. Moldenhauer, J. Viability-based rapid microbiological methods for sterility testing and the need for identification of contamination. PDA Journal of Pharmaceutical Science and Technology. 60(2): 81-88.
2011. Miller, M.J. Detection of Microorganisms Using Micro-Electro-Mechanical Systems (MEMS). European Pharmaceutical Review. 16(6): 7-10.
2011. Miller, M.J. Detection of Microorganisms Using Nucleic Acid and Gene Amplification-Based Rapid Method Technologies. European Pharmaceutical Review. 16(5): 62-65.
2011. Miller, M.J. Detection of Microorganisms Using Optical Spectroscopy-Based Rapid Method Technologies. European Pharmaceutical Review. 16(4): 40-42.
2011. Miller, M.J. Detection of Microorganisms Using Cellular Component-Based Rapid Method Technologies. European Pharmaceutical Review. 16(3): 8-10.
2011. Moldenhauer, J. Proteotypic identification methods - A change in identification methods. American Pharmaceutical Review. 14(3): 34-37.
2011. Miller, M.J. Direct Detection of Microorganisms Using Viability-Based Technologies. European Pharmaceutical Review. 16(2): 14-15.
2011. Miller, M.J. Rapid Microbiological Methods 2011 (A Review of Growth-based Technologies). European Pharmaceutical Review. 16(1): 38-41.
2010. Sampath, R.; Blyn, L.B.; Ecker, D.J. Rapid Molecular Assays for Microbial Contaminant Monitoring in the Bioprocess Industry. PDA Journal of Pharmaceutical Science and Technology. 64(5): 458-464.
2010. Smith, R.; Von Tress, M.; Tubb, C.; Vanhaecke, E. Evaluation of the ScanRDI as a Rapid Alternative to the Pharmacopoeial Sterility Test Method: Comparison of the Limits of Detection. PDA Journal of Pharmaceutical Science and Technology. 64(4): 356-363.
2010. Jimenez, L.; Rana, N.; Travers, K.; Tolomanoska, V.; Walker, K. Evaluation of the Endosafe® Portable Testing System™ for the Rapid Analysis of Biopharmaceutical Samples. PDA Journal of Pharmaceutical Science and Technology. 64(3): 211-221.
2010. London, R.; Schwedock, J.; Sage, A.; Valley, H.; Meadows. J.; Waddinton, M.; Straus, D. An automated system for rapid non-destructive enumeration of growing microbes. PLoS ONE. 5(1): e8609.
2009. Miller, M.J. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles, in Environmental Monitoring, Volume 3. Edited by Jeanne Moldenhauer, PDA and Davis Healthcare International Publishing. 269-288.
2009. Miller, M.J. Real-time environmental monitoring: PAT solutions using rapid microbiological methods. European Pharmaceutical Review. 14(4): 40-46.
2009. Miller, M.J.; Lindsay, H.; Valverde-Ventura, R.; O'Connor, M.J. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part I: Review of the technology and comparative studies with conventional methods. PDA Journal of Pharmaceutical Science and Technology 63(3): 244-257.
2009. Miller, M.J.; Walsh, M.R.; Shrake, J.L.; Dukes, R.E.; Hill, D.B. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part II: Case studies in environmental monitoring during aseptic filling, intervention assessments and glove integrity testing in manufacturing isolators. PDA Journal of Pharmaceutical Science and Technology 63(3): 258-282.
2009. Denoya, C.D. Nucleic acid amplification-based rapid microbiological methods: Are these technologies ready for deployment in the pharmaceutical industry? American Pharmaceutical Review. 12(4).
2002. Costanzo, S.; Borazjani, R.; McCormick, P. Validation of the Scan RDI for routine microbiological analysis of process water. PDA Journal of Pharmaceutical Science and Technology. 56(4): 206-219.
1999. Wallner, G.; Tillmann, D.; Haberer, K. Evaluation of the ChemScan system for rapid microbiological analysis of pharmaceutical water. PDA Journal of Pharmaceutical Science and Technology. 53(2): 70-74.
2012. Miller, M.J. Rapid Micro Methods: New Year, Old Challenges! European Pharmaceutical Review. 17(1): 8-11.
2011. Pan, Y. Challenges and Strategies for the Application of Rapid Microbiological Methods in the Pharmaceutical Industry . European Pharmaceutical Review. 16(5): 66-69.
2011. Duguid, J.; Balkovic, E.; du Moulin, G.C. Rapid Microbiological Methods. Where Are They Now? American Pharmaceutical Review. 14(7): 18-25.
2010. Verdonk, G.P.H.T. ; Willemse, M.J.; Hoefs, S.G.G.; Cremers, G.; van den Heuvel, E.R. The Most Probable Limit of Detection (MPL) for Rapid Microbiological Methods.. J. Microbiological Methods. 82(3): 193-197.
2010. Miller, M.J. The Implementation of Rapid Microbiological Methods, in Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices. Edited by Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell. Business Horizons.
2010. Miller, M.J. Microbiology Series. Article 6: The Implementation of Rapid Microbiological Methods (Rapid Methods at the PDA Global Conference on Pharmaceutical Microbiology). European Pharmaceutical Review. 15(6): 27-31.
2010. Miller, M.J. Microbiology Series. Article 5: The Implementation of Rapid Microbiological Methods (Highlights of Published Papers). European Pharmaceutical Review. 15(5): 9-11.
2010. Moldenhauer, J. Use of a Viability Test Method. Does It Mean What You Think? American Pharmaceutical Review. 13(5): 22-29.
2010. Miller, M.J. Microbiology Series. Article 1: The Implementation of Rapid Microbiological Methods (Overview of RMMs). European Pharmaceutical Review. 15(1): 39-41.
2009. Miller, M.J. It's Time to Get Rapid! PDA Letter. 45(4): 1-21.
2009. Miller, M.J. Rapid Microbiological Methods in Support of Aseptic Processing, in Practical Aseptic Processing: Fill and Finish. Edited by Jack Lysfjord, PDA and Davis Healthcare International Publishing.
2008. Green, S. Microbiology/Microbiologists - Where next? American Pharmaceutical Review. 11(3).
2008. Dalmaso, G. Product real time release for the microbial critical quality attribute using QbD approach. American Pharmaceutical Review. 11(2).
2008. Fleming, W.H. Rapid Microbiology - What is truly possible? American Pharmaceutical Review. 11(7): 34-40.
2008. Middleton, A. Cutting edge technologies and their potential role in pharmaceutical microbiology. American Pharmaceutical Review. 11(1): 58-65.
2008. Miller, M.J. Rapid Microbiological Methods, in Microbiology in Pharmaceutical Manufacturing, 2nd Edition. Edited by Richard Prince, PDA and Davis Healthcare International Publishing.
2007. Johnson R.A. A "PAT" on the back for Rapid Microbiological Methods. European Pharmaceutical Review. 12(4): 84-88.
2007. Newby, P. The significance and detection of VBNC microorganisms. American Pharmaceutical Review. 10(4).
2007. Mach, C.J.; Ball, P.R.; Arbizzani, L. The Advent of Rapid Microbiological Methods: Background, Applications, and Validation . Controlled Environments.
2007. Fung, D.Y.C. Rapid methods and automation in microbiology in pharmaceutical samples. American Pharmaceutical Review. 10(2): 82-86.
2007. Middleton, A. Rapid microbiological methods: Are the needs of the pharmaceutical industry really being met? American Pharmaceutical Review. 10(5): 108-113.
2006. Hussong, D.; Mello, R. Alternative Microbiology Methods and Pharmaceutical Quality Control. American Pharmaceutical Review. 9(1): 62-69.
2006. Miller, M.J. Rapid Microbiological Methods for a New Generation. Pharmaceutical Manufacturing. 2006; 5(2): 14-23.
2006. Cundell, A.M. Opportunities for Rapid Microbial Methods. American Pharmaceutical Review. 9(7): 50-56.
2006. Cundell, A.M. Opportunities for Rapid Microbial Methods. European Pharmaceutical Review. 1: 64-70.
2006. Denoya, C.D.; Colgan, S.T.; du Moulin, G.C. Alternative microbiological methods in the pharmaceutical industry: The need for a new microbiology curriculum. American Pharmaceutical Review. 9(6).
2006. Cundell, T. Top Five Challenges Facing Pharmaceutical Microbiologists. American Pharmaceutical Review. 9(4): 30-34.
2004. Riley, B.S. Rapid Microbiology Methods in the Pharmaceutical Industry. American Pharmaceutical Review. 7(2): 28-31.
2004. Newby, P.; Dalmaso, G.; Lonardi, S.; Riley, B.; Cooney, P.; Tyndall, K. The Introduction of Qualitative Rapid Microbiological Methods for Drug-Product Testing. Pharmaceutical Technology. Process Analytical Technology. 6-12.
2005. Encyclopedia of Rapid Microbiological Methods, Volumes 1-3. Edited by Michael J. Miller. PDA and Davis Healthcare International Publishing.
2003. Rapid Microbiological Methods in the Pharmaceutical Industry. Edited by Martin C. Easter. CRC Press.
References that can be viewed or downloaded will have a blue link in their title. When you click on the link the document will appear in a new window, or you will be redirected to an external website where the reference may be viewed or purchased.
Reference Categories: Regulatory Guidance, Validation Strategies, Economics and Return on Investment, Applications and Methods, RMM Technologies, Quality and General Overviews and Books.
Regulatory Guidance
2012. EMA. Questions and Answers on Post Approval Change Management Protocols. Committee for Medicinal Products for Human Use (CHMP). European Medicines Agency. EMA/CHMP/CVMP/QWP/586330/2010.2012. Federal Register. Food and Drug Administration. Amendments to Sterility Test Requirements for Biological Products Final Rule . 21 CFR Parts 600, 610, and 680 [Docket No. FDA–2011–N–0080]. 77(86): 26162-26175.
2012. Miller, M.J. Rapid Micro Methods and EMA’s Post Approval Change Management Protocol. European Pharmaceutical Review. 17(2): 65-67.
2011. Riley, B. A Regulators View of Rapid Microbiology Methods. European Pharmaceutical Review. 16(5): 59-61.
2011. Food and Drug Administration. Advancing Regulatory Science at FDA. A Strategic Plan. U.S. Department of Health and Human Services, Rockville, Maryland.
2011. Federal Register. Food and Drug Administration. Amendments to Sterility Test Requirements for Biological Products. Proposed Rule. 21 CFR Parts 600, 610, and 680 [Docket No. FDA–2011–N–0080]. 76(119): 36019-36027.
2010. Miller, M.J. Microbiology Series. Article 4: The Implementation of Rapid Microbiological Methods (EMA Perspectives). European Pharmaceutical Review. 15(4): 17-19.
2010. Miller, M.J. Microbiology Series. Article 3: The Implementation of Rapid Microbiological Methods (FDA Perspectives). European Pharmaceutical Review. 15(3): 18-21.
2010. EMA. Post-Authorisation Procedural Advice Human Medicinal Products. Committee for Human Medicinal Products (CHMP). European Medicines Agency. EMEA-H-19984/03 Rev 16.
2009. ICH. Q8: Pharmaceutical Development. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Q8 (R2), Current Step 4 version.
2008. ICH. Q10: Pharmaceutical Quality System. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Q10, Current Step 4 version.
2008. Food and Drug Administration. Draft Guidance for Industry. Validation of Growth-Based Rapid Microbiological Methods for Sterility Testing of Cellular and Gene Therapy Products. U.S. Department of Health and Human Services, Rockville, Maryland.
2008. European Commission. EU guidelines to good manufacturing practice, Annex 1. Manufacture of sterile medicinal products. EudraLex, European Union: Brusselles, Belgium.
2008. Moldenhauer, J. A case for regulatory guidelines for verifying automated microbiological methods. American Pharmaceutical Review. 11(5): 36-43.
2005. ICH. Q9: Quality Risk Management. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline, Q9, Current Step 4 version.
2005. EMA. Quality of medicines Q&A: Part 2. Water - Microbiological Control of Water. Joint CHMP/CVMP Quality Working Party, European Medicines Agency.
2005. Miller, M.J. Rapid Microbiological Methods and FDA's Initiatives for Process Analytical Technology and Pharmaceutical cGMPs for the 21st Century: A Risk Based-Approach. American Pharmaceutical Review. 8(1): 104-107.
2005. Moldenhauer, J. Rapid microbiological methods and the PAT initiative. BioPharm International.
2004. Food and Drug Administration. Final report for pharmaceutical cGMPs for the 21st Century - A risk-based approach. U.S. Department of Health and Human Services, Rockville, Maryland.
2004. Food and Drug Administration. Guidance for industry: PAT - A framework for innovative pharmaceutical development, manufacturing, and quality assurance. U.S. Department of Health and Human Services, Rockville, Maryland.
2004. Food and Drug Administration. Guidance for industry: Sterile drug products produced by aseptic processing -Current good manufacturing practice. U.S. Department of Health and Human Services, Rockville, Maryland.
2003. Food and Drug Administration. Guidance for industry: Comparability Protocols - Protein Drug Products and Biological Products, Chemistry, Manufacturing, and Controls Information. U.S. Department of Health and Human Services, Rockville, Maryland.
Validation Strategies
2010. Miller, M.J. Microbiology Series. Article 2: The Implementation of Rapid Microbiological Methods (Validation Strategies). European Pharmaceutical Review. 15(2): 24-26.2010. Duguid, J. Top Ten Validation Considerations When Implementing a Rapid Mycoplasma Test. American Pharmaceutical Review. 13(4): 26-31.
2010. Miller, M.J. Developing a validation strategy for rapid microbiological methods. American Pharmaceutical Review. 13(3): 28-33.
2010. Miller, M.J.; Moldenhauer, J. Revision of Technical Report #33. American Pharmaceutical Review. 13(1): 86-91.
2009. USP 32-NF27. General Information Chapter <1223>, Validation of alternative microbiological methods. U.S. Pharmacopeial Convention, Rockville, Maryland.
2009. European Pharmacopoeia 6.4. Informational chapter 5.1.6. Alternative methods for control of microbiological quality. European Directorate for the Quality of Medicines (EDQM), Strasbourg, France.
2008. Newby, P. Implementation, validation and registration of rapid microbiological methods. European Pharmaceutical Review. 13(3): 67-73.
2007. Green, S. Industry strategy case study E: How to select, validate, and implement a rapid microbiology method and get it approved - A true story. American Pharmaceutical Review. 10(5): 102-107.
2005. Sutton, S. Validation of Alternative Microbiology Methods for Product Testing: Quantitative and Qualitative Assays. Pharmaceutical Technology. 29(4): 118-122.
2005. Newby, P. Implementation, validation and registration. European Pharmaceutical Review. 10(2): 92-95.
2004. Newby, P.J. Implementation, validation and registration of rapid microbiological methods. American Pharmaceutical Review. 7(4): 10-15.
2000. PDA. Technical Report #33. Evaluation, Validation and Implementation of New Microbiological Testing Methods. PDA Journal of Pharmaceutical Science and Technology. Supplement 54(3). Parenteral Drug Association, Bethesda, Maryland.
Economics and Return on Investment
2009. Miller, M.J. Breaking the rapid microbiological method financial barrier: A case study in RMM return on investment and economic justification. BioPharm International. 22(9): 44-53.2009. Miller, M.J. Rapid microbiological methods and demonstrating a return on investment: It's easier than you think! American Pharmaceutical Review. 12(5): 42-47.
2009. Gadal, P.; Yvon, P. Rapid Microbio ROI - Calculating scientific benefits as return on investment dollars. Pharmaceutical Formulation & Quality. 11(3): 44-47.
2009. Miller, M.J. Ensuring ROI from your RMM. Pharmaceutical Manufacturing. 8(6): 32-35.
2009. Miller, M.J. Quality Risk Management and the Economics of Implementing Rapid Microbiological Methods. European Pharmaceutical Review. 2: 66-73.
2006. Ghandi, M. Efficiency with Rapid Microbiology Methods. American Pharmaceutical Review. 9(5): 16-19.
Applications and Methods
2012. Ragheb, S.M.; Yassin, A.S.; Amin, M.A. The Application of Uniplex, Duplex, and Multiplex PCR for the Absence of Specified Microorganism Testing of Pharmaceutical Excipients and Drug Products. PDA Journal of Pharmaceutical Science and Technology. 66(4): 307-317.2012. Jimenez, L.; Rana, N.; Amalraj, J.; Walker, K.; Travers, K. Validation of the BacT/ALERT 3D System for Rapid Sterility Testing of Biopharmaceutical Samples. PDA Journal of Pharmaceutical Science and Technology. 66(1): 38.54.
2011. Miller, M.J. QbD, PAT, and the Future of Microbiology. Environmental monitoring with RMM. Contract Pharma. 13(4): 70-73.
2011. Jimenez, L. Molecular Applications to Pharmaceutical Processes and Cleanroom Environments. PDA Journal of Pharmaceutical Science and Technology. 65(3): 242-253.
2011. Gray, J.C.; Morandell, D.; Gapp, G.; Le Goff, N.; Neuhaus, G.; Staerk, A. Identification of Micro-Organisms after Milliflex Rapid Detection—A Possibility To Identify Nonsterile Findings in the Milliflex Rapid Sterility Test. PDA Journal of Pharmaceutical Science and Technology. 65(1): 42-54.
2011. Gordon, O.; Gray, J.C.; Anders, H.J.; Staerk, A.; Schlaefli, O.; Neuhaus, G. Overview of Rapid Microbiological Methods Evaluated, validated and Implemented for Microbiological Quality Control. European Pharmaceutical Review. 16(2): 9-13.
2010. Sampath, R., Blyn, L.B.; Ecker, D.J. Rapid Molecular Assays for Microbial Contaminant Monitoring in the Bioprocess Industry. PDA Journal of Pharmaceutical Science and Technology. 64(5): 458-464.
2010. Gray, J.C.; Staerk, A.; Berchtold, M.; Mercier, M.; Neuhaus, G.; Wirth, A. Introduction of a Rapid Microbiological Method as an Alternative to the Pharmacopoeial Method for the Sterility Test. American Pharmaceutical Review. 13(6): 88-94.
2010. McIver, D. Using RMM for Environmental Monitoring. Pharmaceutical Manufacturing. 9(7): 37-38.
2010. Gray, J.C.; Staerk, A.; Berchtold, M.; Hecker, W.; Neuhaus, G.; Wirth, A. Growth-promoting Properties of Different Solid Nutrient Media Evaluated with Stressed and Unstressed Micro-organisms: Prestudy for the Validation of a Rapid Sterility Test. PDA Journal of Pharmaceutical Science and Technology. 64(3): 249-263.
2010. Denoya, C.; Sessions, D.; Shabushnig, J. A Rapid Microbiological Assay to Monitor the Effectiveness of a Vaccine Injector Sanitization Following a Microbial Challenge Procedure. American Pharmaceutical Review. 13(4): 54-61.
2009. Williams , K.L. The BET as a Backdrop for Establishing PAT and RMM Goals. American Pharmaceutical Review. 12(7): 42-47.
2009. Duguid, J.; Kielpinski, G.; Seymour, B.; du Moulin, G. Risk Assessment for a Rapid Mycoplasma Test Optimized for Cell Therapy Products. American Pharmaceutical Review. 12(6): 100-104.
2009. Bagur, E. Concurrent Evaluation of both Compendial and Rapid Methods (ATP Bioluminescence) for Monitoring Water Quality in Pharmaceutical Manufacturing. European Pharmaceutical Review. 14(3): 58-68.
2008. Gressett, G.; Vanhaecke, E.; Moldenhauer, J. Why and how to implement a rapid sterility test. PDA Journal of Pharmaceutical Science and Technology. 62(6): 429-444.
2007. McDaniel, A. Microbial Detection in Mammalian Cell Culture Systems. American Pharmaceutical Review, 10(1): 24-29.
2007. Anders, H-J.; Keller, M.; berchtold, M.; Hecker, W. Polyphasic approach to microbial identification. American Pharmaceutical Review. 10(6): 46-52.
2006. Moldenhauer, J. Viability-based rapid microbiological methods for sterility testing and the need for identification of contamination. PDA Journal of Pharmaceutical Science and Technology. 60(2): 81-88.
RMM Technologies
2012. Miller, M.J. Case Study of a New Growth-Based Rapid Microbiological Method (RMM) that Detects the Presence of Specific Organisms and Provides an Estimation of Viable Cell Count. American Pharmaceutical Review. 15(2): 18-25.2011. Miller, M.J. Detection of Microorganisms Using Micro-Electro-Mechanical Systems (MEMS). European Pharmaceutical Review. 16(6): 7-10.
2011. Miller, M.J. Detection of Microorganisms Using Nucleic Acid and Gene Amplification-Based Rapid Method Technologies. European Pharmaceutical Review. 16(5): 62-65.
2011. Miller, M.J. Detection of Microorganisms Using Optical Spectroscopy-Based Rapid Method Technologies. European Pharmaceutical Review. 16(4): 40-42.
2011. Miller, M.J. Detection of Microorganisms Using Cellular Component-Based Rapid Method Technologies. European Pharmaceutical Review. 16(3): 8-10.
2011. Moldenhauer, J. Proteotypic identification methods - A change in identification methods. American Pharmaceutical Review. 14(3): 34-37.
2011. Miller, M.J. Direct Detection of Microorganisms Using Viability-Based Technologies. European Pharmaceutical Review. 16(2): 14-15.
2011. Miller, M.J. Rapid Microbiological Methods 2011 (A Review of Growth-based Technologies). European Pharmaceutical Review. 16(1): 38-41.
2010. Sampath, R.; Blyn, L.B.; Ecker, D.J. Rapid Molecular Assays for Microbial Contaminant Monitoring in the Bioprocess Industry. PDA Journal of Pharmaceutical Science and Technology. 64(5): 458-464.
2010. Smith, R.; Von Tress, M.; Tubb, C.; Vanhaecke, E. Evaluation of the ScanRDI as a Rapid Alternative to the Pharmacopoeial Sterility Test Method: Comparison of the Limits of Detection. PDA Journal of Pharmaceutical Science and Technology. 64(4): 356-363.
2010. Jimenez, L.; Rana, N.; Travers, K.; Tolomanoska, V.; Walker, K. Evaluation of the Endosafe® Portable Testing System™ for the Rapid Analysis of Biopharmaceutical Samples. PDA Journal of Pharmaceutical Science and Technology. 64(3): 211-221.
2010. London, R.; Schwedock, J.; Sage, A.; Valley, H.; Meadows. J.; Waddinton, M.; Straus, D. An automated system for rapid non-destructive enumeration of growing microbes. PLoS ONE. 5(1): e8609.
2009. Miller, M.J. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles, in Environmental Monitoring, Volume 3. Edited by Jeanne Moldenhauer, PDA and Davis Healthcare International Publishing. 269-288.
2009. Miller, M.J. Real-time environmental monitoring: PAT solutions using rapid microbiological methods. European Pharmaceutical Review. 14(4): 40-46.
2009. Miller, M.J.; Lindsay, H.; Valverde-Ventura, R.; O'Connor, M.J. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part I: Review of the technology and comparative studies with conventional methods. PDA Journal of Pharmaceutical Science and Technology 63(3): 244-257.
2009. Miller, M.J.; Walsh, M.R.; Shrake, J.L.; Dukes, R.E.; Hill, D.B. Evaluation of the BioVigilant IMD-A, a novel optical spectroscopy technology for the continuous and real-time environmental monitoring of viable and nonviable particles. Part II: Case studies in environmental monitoring during aseptic filling, intervention assessments and glove integrity testing in manufacturing isolators. PDA Journal of Pharmaceutical Science and Technology 63(3): 258-282.
2009. Denoya, C.D. Nucleic acid amplification-based rapid microbiological methods: Are these technologies ready for deployment in the pharmaceutical industry? American Pharmaceutical Review. 12(4).
2002. Costanzo, S.; Borazjani, R.; McCormick, P. Validation of the Scan RDI for routine microbiological analysis of process water. PDA Journal of Pharmaceutical Science and Technology. 56(4): 206-219.
1999. Wallner, G.; Tillmann, D.; Haberer, K. Evaluation of the ChemScan system for rapid microbiological analysis of pharmaceutical water. PDA Journal of Pharmaceutical Science and Technology. 53(2): 70-74.
Quality and General Overviews
2012. Miller, M.J. Framework for Fast Microbiological Assessment. Pharmaceutical Manufacturing. 12(3): 39-41.2012. Miller, M.J. Rapid Micro Methods: New Year, Old Challenges! European Pharmaceutical Review. 17(1): 8-11.
2011. Pan, Y. Challenges and Strategies for the Application of Rapid Microbiological Methods in the Pharmaceutical Industry . European Pharmaceutical Review. 16(5): 66-69.
2011. Duguid, J.; Balkovic, E.; du Moulin, G.C. Rapid Microbiological Methods. Where Are They Now? American Pharmaceutical Review. 14(7): 18-25.
2010. Verdonk, G.P.H.T. ; Willemse, M.J.; Hoefs, S.G.G.; Cremers, G.; van den Heuvel, E.R. The Most Probable Limit of Detection (MPL) for Rapid Microbiological Methods.. J. Microbiological Methods. 82(3): 193-197.
2010. Miller, M.J. The Implementation of Rapid Microbiological Methods, in Microbiology and Sterility Assurance in Pharmaceuticals and Medical Devices. Edited by Madhu Raju Saghee, Tim Sandle and Edward C. Tidswell. Business Horizons.
2010. Miller, M.J. Microbiology Series. Article 6: The Implementation of Rapid Microbiological Methods (Rapid Methods at the PDA Global Conference on Pharmaceutical Microbiology). European Pharmaceutical Review. 15(6): 27-31.
2010. Miller, M.J. Microbiology Series. Article 5: The Implementation of Rapid Microbiological Methods (Highlights of Published Papers). European Pharmaceutical Review. 15(5): 9-11.
2010. Moldenhauer, J. Use of a Viability Test Method. Does It Mean What You Think? American Pharmaceutical Review. 13(5): 22-29.
2010. Miller, M.J. Microbiology Series. Article 1: The Implementation of Rapid Microbiological Methods (Overview of RMMs). European Pharmaceutical Review. 15(1): 39-41.
2009. Miller, M.J. It's Time to Get Rapid! PDA Letter. 45(4): 1-21.
2009. Miller, M.J. Rapid Microbiological Methods in Support of Aseptic Processing, in Practical Aseptic Processing: Fill and Finish. Edited by Jack Lysfjord, PDA and Davis Healthcare International Publishing.
2008. Green, S. Microbiology/Microbiologists - Where next? American Pharmaceutical Review. 11(3).
2008. Dalmaso, G. Product real time release for the microbial critical quality attribute using QbD approach. American Pharmaceutical Review. 11(2).
2008. Fleming, W.H. Rapid Microbiology - What is truly possible? American Pharmaceutical Review. 11(7): 34-40.
2008. Middleton, A. Cutting edge technologies and their potential role in pharmaceutical microbiology. American Pharmaceutical Review. 11(1): 58-65.
2008. Miller, M.J. Rapid Microbiological Methods, in Microbiology in Pharmaceutical Manufacturing, 2nd Edition. Edited by Richard Prince, PDA and Davis Healthcare International Publishing.
2007. Johnson R.A. A "PAT" on the back for Rapid Microbiological Methods. European Pharmaceutical Review. 12(4): 84-88.
2007. Newby, P. The significance and detection of VBNC microorganisms. American Pharmaceutical Review. 10(4).
2007. Mach, C.J.; Ball, P.R.; Arbizzani, L. The Advent of Rapid Microbiological Methods: Background, Applications, and Validation . Controlled Environments.
2007. Fung, D.Y.C. Rapid methods and automation in microbiology in pharmaceutical samples. American Pharmaceutical Review. 10(2): 82-86.
2007. Middleton, A. Rapid microbiological methods: Are the needs of the pharmaceutical industry really being met? American Pharmaceutical Review. 10(5): 108-113.
2006. Hussong, D.; Mello, R. Alternative Microbiology Methods and Pharmaceutical Quality Control. American Pharmaceutical Review. 9(1): 62-69.
2006. Miller, M.J. Rapid Microbiological Methods for a New Generation. Pharmaceutical Manufacturing. 2006; 5(2): 14-23.
2006. Cundell, A.M. Opportunities for Rapid Microbial Methods. American Pharmaceutical Review. 9(7): 50-56.
2006. Cundell, A.M. Opportunities for Rapid Microbial Methods. European Pharmaceutical Review. 1: 64-70.
2006. Denoya, C.D.; Colgan, S.T.; du Moulin, G.C. Alternative microbiological methods in the pharmaceutical industry: The need for a new microbiology curriculum. American Pharmaceutical Review. 9(6).
2006. Cundell, T. Top Five Challenges Facing Pharmaceutical Microbiologists. American Pharmaceutical Review. 9(4): 30-34.
2004. Riley, B.S. Rapid Microbiology Methods in the Pharmaceutical Industry. American Pharmaceutical Review. 7(2): 28-31.
2004. Newby, P.; Dalmaso, G.; Lonardi, S.; Riley, B.; Cooney, P.; Tyndall, K. The Introduction of Qualitative Rapid Microbiological Methods for Drug-Product Testing. Pharmaceutical Technology. Process Analytical Technology. 6-12.
Books
2012. Encyclopedia of Rapid Microbiological Methods, Volume 4. Edited by Michael J. Miller. PDA and Davis Healthcare International Publishing.2005. Encyclopedia of Rapid Microbiological Methods, Volumes 1-3. Edited by Michael J. Miller. PDA and Davis Healthcare International Publishing.
2003. Rapid Microbiological Methods in the Pharmaceutical Industry. Edited by Martin C. Easter. CRC Press.
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