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Steven A. Weitzel

Mr. Weitzel received his Masters in Business Administration at Washington University in St. Louis and his B.S. in Chemical Engineering from the University of Missouri.


Steve has been the Director of Marketing at Novaflux Technologies since 1998, responsible for business development and commercialization contacts. Also serving as Validation Director, his technical duties include applications development, process validation and regulatory compliance and FDA submissions for the company's core technologies including low temperature sterilization, medical device decontamination, and disinfection and cleaning of purification membranes and process equipment.

Steve has over 20 years experience in FDA regulated industry in engineering, operations, marketing and validation for pharmaceuticals, medical devices and diagnostics, bulk compounds and personal care products including Dow Chemical, Mallinckrodt Medical, and divisions of Merck and Bristol-Myers Squibb. He was recently responsible for technical operations for a chemical company making medical/scientific cleaning agents for AMSCO and Castle-MDT. He managed international technical marketing for Calgon Vestal (now Steris) and started up their pharmaceutical contamination control group, developed and introduced their CIP product line, managed and expanded disinfectant and sterilant products (Spor-Klenz, Septihol, LpHst), was responsible for cGMP training programs and for cleaning validation support and services.

Steve is a member of PDA and the International Society for Pharmaceutical Engineering. As a recognized expert in the field of FDA regulated contamination control, he has consulted or conducted seminars or training for the world's leading pharmaceutical, biotech and medical device companies, and has made numerous technical presentations on the topics of cGMP compliance, cleaning validation, contamination control and infection control.












PUBLICATIONS:

1. "Validation of Sanitization," Parenteral Drug Association Annual Meeting 1991
2. "Biodecontamination for FDA Regulated Facilities," Center for Professional Advancement, New Brunswick, San Francisco, Amsterdam, 1990-1995.
3. "Cleaning Validation," PharmTech Conferences, 1993-1996
4. "Process Cleaning and Cleaning Validation"; Institute for Applied Technology, Boston, San Juan, Chicago, London 1992, 1993, 1994
5. "Cleaning and Disinfection," U. of Tenn. School of Pharmacy Course, 1992-1994.
6. "Environmental Monitoring of Non-Sterile Areas"; PDA Spring Meeting 1994
7. "Microbial Control and Disinfection", WestPharm 1995, San Diego
8. "Microbial Control for Advanced Aseptic Processing"; PharmTech Conference; San Juan, New Brunswick 1995, 1996
9. "Critical Process Cleaning and Cleaning Validation "; Center for Professional Advancement, New Brunswick, San Francisco, Boca Raton, San Mateo, Amsterdam, The Hague, Lisbon, Tempere, Madrid, 1996-2002.
10. "Critical Cleaning and Microbial Control for Barrier Technology and Advanced Aseptic Processing," Center for Professional Advancement, New Brunswick, Amsterdam, 1996-2001
11. "Recent Advances in Cleaning and Cleaning Validation," WorldPharm Conf., 1998.
12. "Biodecontamination and Environmental Monitoring," Center for Professional Advancement, New Brunswick, Amsterdam, 1999-2001
13. Labib, M.E., Lai, R., Mahon, G., Tabani, Y., Weitzel, S.A., "Membrane Cleaning Process for RO, UF and MF Used in High-Purity Water Treatment," 2001 Ultrapure Water Conference, Philadelphia, PA.
14. Labib, M.E., Lai, R., Weitzel, S.A., "Effective Biofilm Removal Process for High-Purity Water Applications," 2001 Ultrapure Water Conference, Philadelphia, PA.
15. Labib, M. E., Tabani, Y., Materna, P., Weitzel, S. A., Sherman, R. A. and Kapoian, T., "Novel and effective method for reprocessing hemodialyzers," 47th Annual ASAIO Conference, New York City, NY, June 7-9, 2001
16. Singh, R., Lai, R., Tabani, Y., Weitzel, S. A., Williams, H. N. and Labib, M. E., "Biofilm removal from dental unit waterlines with a novel method based on turbulent two-phase flow dynamics," (in preparation), 2002.




e-mail: weitzel@novaflux.com





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