Publications


R. E. Madsen and D. F. Magin (1976). “Simultaneous Quantitative GLC Determination of Chlorpheniramine Maleate and Phenylpropanolamine Hydrochloride in a Cold Tablet Preparation,” J. Pharm. Sci., 65, 924.

 

R. E. Madsen (1994). “U.S. v. Barr Laboratories: A Technical Perspective,” PDA J. Pharm. Sci. Technol., 48, 176-179.

 

R. E. Madsen (1997). “Process Simulation Testing for Aseptically Filled Products,” Proceedings, Global Pharmaceutical Manufacturing in the 21st Century, Osaka, Japan, 37-40.

 

R. E. Madsen and T. H. Meltzer (1998). “An Interpretation of the Pharmaceutical Industry Survey of Current Sterile Filtration Practices,” PDA J. Pharm. Sci. Technol., 52, 337-339.

 

J. P. Agalloco, J. E. Akers and R. E. Madsen (1998). “Moist Heat Sterilization-Myths and Realities,” PDA J. Pharm. Sci. Technol., 52, 346-350.

 

T. H. Meltzer, R. E. Madsen and M. W. Jornitz (1999). “Considerations for Diffusive Airflow Integrity Testing,” PDA J. Pharm. Sci. Technol., 53, 56-59.

 

Madsen, R. E. (2000). “Technical Guidance for the Pharmaceutical Industry: PDA's View of the CPMP Decision Tree Guidance and a Proposed Alternative.” 15th ICCCS International Symposium and 31st R3-Nordic Symposium on Contamination Control, Copenhagen, Denmark.

 

Moldenhauer, J. E. and R. E. Madsen (2000). "Parametric Release-Much Ado About Nothing." PDA J. Pharm. Sci. Technol. 54(1): 32.

 

R. E. Madsen (2001). “Real Compliance and How to Achieve It,” PDA J. Pharm. Sci. Technol., 55, 59-64.

 

Agalloco, J. P., J. E. Akers, et al. (2001). "Technical Report No. 34, Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products." PDA J. Pharm. Sci. Technol. 55(5, Supplement).

 

Madsen, R. E. (2001). “New Microbiological Test Methods, PDA Technical Report No. 33.” 2001 PDA International Congress, Courses and Exhibition, Kyoto, Japan, PDA.

 

Agalloco, J. P., J. E. Akers, et al. (2002). "Technical Report No. 36, Current Practices in the Validation of Aseptic Processing-2001." PDA J. Pharm. Sci. Technol. 56(3, Supplement).

 

Jornitz, M. W., J. E. Akers, et al. (2002). "Considerations in Sterile Filtration-Part I: The Changed Role of Filter Integrity Testing." PDA J. Pharm. Sci. Technol. 56(1): 4-10.

 

Jornitz, M. W., J. E. Akers, et al. (2003). "Considerations in Sterile Filtration. Part II: The Sterilizing Filter and Its Organism Challenge: A Critique of Regulatory Standards." PDA J. Pharm. Sci. Technol. 57(2): 88-96.

 

Madsen, R. E. (2003). “FDA's Concept Paper, Sterile Drug Products Produced by Aseptic Processing.” PDA International Congress, Prague, Czech Republic, PDA.

 

Madsen, R. E. (2003). "The Future of Aseptic Processing." Pharmaceutical Technology Aseptic Processing Supplement: 41-42.

 

Agalloco, J. P., J. E. Akers, et al. (2004). "Aseptic Processing: A Review of Current Industry Practice." Pharmaceutical Technology 28(10): 126-150.

 

Agalloco, J. P. and R. E. Madsen (2004). "A Critical Review of FDA's 2003 Draft Guidance and a Proposed Alternative." Pharmaceutical Technology Aseptic Processing Supplement: 16-22.

 

Hussong, D. and R. E. Madsen (2004). "Analysis of Environmental Microbiology Data from Cleanroom Samples." Pharmaceutical Technology Aseptic Processing Supplement: 10-15.

 

Madsen, R. E. (2004). "The Future of Aseptic Processing-An Update." Pharmaceutical Technology Aseptic Processing Supplement: 8.

 

Madsen, R. E. (2005). "Aseptic Processing, Minimizing Risk Through Technology." Pharmaceutical Technology Aseptic Processing Supplement: s8.

 

Madsen, R. E. (2005). “The Quality Systems Approach to Real Compliance.” The 36th Symposium of R3-Nordic and the 5th European Parenteral Conference of the ESPC, Linköping, Sweden.

 

Madsen, R. E. (2005). "The quality systems approach to real compliance - a US point of view." European Journal of Parenteral & Pharmaceutical Sciences 10(4): 101-106.

 

Agalloco, J. P., J. E. Akers, et al. (2006). "What is Advanced Aseptic Processing?" Pharmaceutical Manufacturing 5(2): 25-27.

 

Madsen, R. E. (2006). Filter Validation. Sterile Filtration. M. W. Jornitz. Heidelberg, Springer-Verlag GmbH. 98: 125-141.

 

Madsen, R. E., J. E. Akers, et al. (2006). "The Use of Model Organisms in Sterilizing Filtration. " Pharmaceutical Technology Aseptic Processing Supplement: s38-s42.

 

Agalloco, J. P., J. E. Akers, et al. (2007). "Choosing Technologies for Aseptic Processing: "Back to the Future, Forward to the Past?" Pharmaceutical Engineering (January/February): 8-16.

 

Jornitz, M. W., R. E. Madsen, et al. (2007). "The Relationship among Pore-Size Ratings, Bubble Points, and Porosity." Pharmaceutical Technology 31(1): 84-100.

 

Madsen, R. E., M. W. Jornitz, et al. (2007). "The Importance of Pre-Use Integrity Testing in Sterilizing Filtration." Pharmaceutical Technology Aseptic Processing Supplement: s12-s16.

 

Meltzer, T. H., R. C. Livingston, et al. (2009). "Reverse Osmosis as a Means of Water For Injection Production: A Response to the Position of the European Medicines Agency." PDA J. Pharm. Sci. Technol. 63(1): 1-7.

 

Agalloco, J. P., J. E. Akers, et al. (2009). "Risk Management, cGMP, and the Evolution of Aseptic Processing Technology." PDA J. Pharm. Sci. Technol. 63(1): 8-10.

 

Agalloco, J. P., J. E. Akers, et al. (2009). "Revisiting the Moist Heat Sterilization Myths." PDA J. Pharm. Sci. Technol. 63(2): 89-102.

 

Madsen, R. E., T. H. Meltzer (2009). “Critical Influences of Particles, Pores, and Prefilters in Sterilizing Filtration.” PDA J. Pharm. Sci. Technol. 63(3): 240-244.

 

Madsen, R. E., R. T. Cherris, J. G. Shabushnig, and D. G. Hunt (2009). “Visible Particulates in Injections—A History and a Proposal to Revise USP General Chapter Injections <1>.” Pharmacopeial Forum 35 (5): 1383-1387.

 

Meltzer, T. H., R. E. Madsen, J. P.  Agalloco, J. E. Akers, M. W. Jornitz (2009). Letter to the Editor Re: "Diminutive Bacteria Useful for 0.2-μm Filter Studies, FDA's Brorson Says" 10/9/09 BioPharm International.Com [Online].

 

Madsen, R. E., T. H. Meltzer and M. W. Jornitz (2010). "How Pore and Fibrous Interstice Structure Influence Filter Performance Part 1: Fluid Effects and Operations." BioProcess International 8(4): 58-64.

 

Madsen, R. E., T. H. Meltzer and M. W. Jornitz (2010). "How Pore and Fibrous Interstice Structure Influence Filter Performance Part 2: Particulate Effects and Experimental Findings." BioProcess International 8(5): 48-54.

 

Davis, B. S., Crichton, M., Farquharson, G. J., Madsen, R. E.,  Von Stwolinski, M., Biskup, J. (2011). Sterile Product Manufacturing Facilities. Second ed.; Baseline® Pharmaceutical Engineering Guide for New and Renovated Facilities, Vol. 3; International Society for Pharmaceutical Engineering: Tampa, Florida.

 

Bartel, K., H. Baseman, G. Gori, et al. (2012). "Pre-use/Post-sterilization Integrity Testing of Sterilizing Grade Filters." PDA J. Pharm. Sci. Technol. 66(5): 394-395.

 

Agalloco, J. P.; Lindboe Jr., W. G. and Madsen, R. E., Sterilization Processes and Sterility Assurance. In Remington The Science and Practice of Pharmacy, 22 ed.; Allen Jr., L. V., Ed. Pharmaceutical Press: Philadelphia, 2013; Vol. 1, pp 835-859.

 

Madsen, R. E. and J. E. Moldenhauer, Eds. (2013). Contamination Control in Healthcare Product Manufacturing, Vol.1, PDA, Bethesda, MD and DHI Publishing, LLC, River Grove, IL.

 

Madsen, R. E. and J. E. Moldenhauer, Eds. (2014). Contamination Control in Healthcare Product Manufacturing, Vol.2, PDA, Bethesda, MD and DHI Publishing, LLC, River Grove, IL.

 

Madsen, R. E. and J. E. Moldenhauer, Eds. (2014). Contamination Control in Healthcare Product Manufacturing, Vol.3, PDA, Bethesda, MD and DHI Publishing, LLC, River Grove, IL.

 

Madsen, R. E. and M. W. Jornitz, Eds. (2015). Lessons of Failure: When Things Go Wrong in Pharmaceutical Manufacturing, PDA, Bethesda, MD and DHI Publishing, LLC, River Grove, IL.

 

Madsen, R. E. and M. W. Jornitz (2016). "Sterilizing-Grade Filtration Membrane Bubble Point Requirements During Product Bacteria Challenge Tests Utilized In Process Validation." American Pharmaceutical Review 19(1), pp 14-21.

 

Madsen, R. E. and J. E. Moldenhauer, Eds. (2016). Contamination Control in Healthcare Product Manufacturing, Vol.4, PDA, Bethesda, MD and DHI Publishing, LLC, River Grove, IL.

 

Akers, J. E., J. P. Agalloco and R. E. Madsen (2016). "Deconstructing the Regulatory Spiral." Bioprocessing and Sterile Manufacturing 2016 a Pharmaceutical Technology eBook: 24-30.

 

Madsen, R. E. (2017). "Perspective: From Art to Science." Pharmaceutical Technology: (41)7, p 18.

 

Madsen, R. E. (2017). "Perspective: Innovations and Regulatory Implications." Pharmaceutical Technology: (41)7, p 81.