Tevfik Gemci, PhD, CQE
2810 17th Street #208, Huntington Beach, CA 92648
Phone: +1 (562) 284 9223 • E-mail: tgemci@gmail.com

EDUCATION:
Biotechnology Engineering Certificate, UCLA Extension, Los Angeles, CA (07/2021 – 12/2022)
1. Manufacturing Process in Biotechnology, Grade A
2. Process Development and Quality Systems in Biotechnology, Grade A+
3. Regulatory Affairs in Biotechnology, Grade B+
4. Fundamentals of Biotechnology Engineering, Grade A+
5. Biomaterials and Biocompatibility, Grade A+
6. Medical Device Manufacturing Processes, Equipment, and Techniques, Grade A+

CQE (Certified Quality Engineer), American Society for Quality (ASQ), Orange Empire Section, June 2016.

PhD in Mechanical and Environmental Engineering, Technical University of Kaiserslautern, Kaiserslautern, Germany (08/1987 – 28 July 1993).
Dissertation title: “Particle Capturing in Wet Scrubbers in Consideration of Heat and Mass Transfer Processes.” Advisor: Prof. Dr.-Ing. Fritz Ebert.

Graduate Mechanic Summer School, Turkey Scientific and Technical Research (TUBITAK), Canakkale, Turkey (08/1984)

MSc in Mechanical Engineering (Energy Program), Istanbul Technical University, Istanbul, Turkey (08/1983 – 03/1986).
Thesis title: “Second Law Analysis of Chemical Reactions.” Advisor: Prof. Dr. Aksel Öztürk.

BSc in Mechanical Engineering, Istanbul Technical University, Turkey (08/1979 – 07/1983).

AREAS OF SPECIALIZATION:
Mechanical Engineering: Thermal-Fluid Mechanics; CFD; Microfluidics; Heat and Mass Transfer; Spray and Aerosol Dynamics (Spray Nozzles, Fuel Injections, Atomization, Electrosprays, Ultrasonic Nozzles, Coating Sprays, Spray Dryers).

Environmental Engineering: Air Pollution Control Technologies; Wet Scrubbers; Bag Filters; Flue Gas Desulphurization (FGD) Absorbers; Air Quality Modeling; Dispersion Pollution Dispersion Modeling; Air Quality Measurements; Aerosol Dynamics.

Biomedical Engineering: Inhalation Therapy Medical Sprays; Nebulizers; Dry Powder Inhaler; Particle Deposition in Pulmonary Airways; Inhalation Toxicology.

Pharmaceutical Engineering: Tablet Coating for Controlled-release Drug Delivery; Rheology of non-Newtonian Fluids; Injection of non-Newtonian Fluids; NanoCrystal Colloidal Dispersions; Particle Characterization; Atomization of non-Newtonian Fluids; Pharmaceutical Cabinet Washers; Glassware Washers; Spray Dryers; Steam Sterilizers.

CSV, Validation & Quality Engineering:
Equipment and cleaning validations:
Aseptic Process Validation; Incubators; Refrigerators/Freezers; Beckman Coulter Flow Cytometer (Dendreon Biotechnology); Automated Blood Cell Processing Machine (Fresenius Kabi) (Dendrean Biotechnology); NC-200 Automated Cell Counter (ChemoMetec) (Dendreon Biotechnology); Sterile Tube Welder (Terumo TSCD II) (Dendreon Biotechnology); CIP and COP Cleaning Validations for OTC Cosmetic Products (Neutrogena – a Johnson & Johnson company); Packaging Validation for OTC Healthcare Products (McNeil – a Johnson & Johnson company); CIP and COP Cleaning Validation for OTC Healthcare Products (McNeil – a Johnson & Johnson company); Thermal Validation (Kaye Validator); Pharmaceutical Cabinet Washers (McNeil); STERIS-Reliance Glassware Washer (BBraun Medical); STERIS-Amsco Steam Sterilizer (BBraun Medical); STERIS-Joselyn Steam BIER (Biological Indicator Evaluation Resistometer) Vessel (BBraun Medical); Flame Photometer (BBraun Medical); GETINGE GE 6913 Steam Sterilizer (BBraun Medical); Validations of 4 new 20,000L and 30,000L IV Solutions Mixing Tanks (BBraun Medical); CARON Photostability Chamber (BBraun Medical); IV bags underwater leak test system (BBraun Medical).

Computer System Validation (CSV) Qualifications:
PLC (Programmable Logic Controllers) and SCADA (Supervisory Control and Data Acquisition) updates in Sterilizers and Isolators (BBraun Medical), and HMI Systems validations for Aseptic Filling/Packing Machines and Isolators (BBraun Medical), Sapphire LIMS software update qualifications for QA/QC laboratory testing (BBraun Medical), Mobile Device testing validations for QC Microbiology, Chemistry, and PM tests (BBraun Medical), Software Development Lifecycle (SDLC), Software Implementation Lifecycle (SILC), COTS product, Agile QA Testing, HIPAA Security Test, Excel Spreadsheet Validation (BBraun Medical, Software of Automated Blood Cell Processing Machine (Fresenius Kabi) (Dendrean Biotechnology), Software of Beckman Coulter Flow Cytometer (Dendreon Biotechnology), Software updates of 13 Steam Sterilization Vessels for IV solutions products (BBraun Medical); Getinge Autoclave Control Panel Upgrade (replacing PACS2000 with Allen Bradley Control Logix PLC system) (BBraun Medical), Videojet Dataflex Barcode Printer (BBraun Medical), BBraun Virtual Machine/Server qualification for operating system, security, and network connectivity (BBraun Medical), SolidWorks Server Operating System upgrade (BBraun Medical), Duplex Container Label 2D Datamatrix Barcode Printer Upgrade (BBraun Medical)

Process Validation; Equipment Validation; Cleaning Validation; Cleaning Cycle Development; SOP and URS reports; cGMP; ISO 13485 QMS (Medical Devices-Quality Management Systems); QRM (Quality Risk Management); CAPA (Corrective and Preventive Actions); Six Sigma; FMEA (Failure Mode and Effects Analysis); FTA (Fault Tree Analysis); Installation Qualification (IQ); Operational Qualification (OQ); Performance Qualification (PQ); ISO Standards; GAMP, 21 CFR Parts 210 and 211 (cGMP for drugs and finished pharmaceuticals); 21 CFR Part 11 (cGMP for electronic records), 21 CFR Part 820 (Quality System Regulation), EU GMP Annex 11.


EMPLOYMENTS:

(06/2015 – Present): Validation Engineer Lead, BBraun Medical Inc, Irvine, CA.
Interface with Management personnel in Engineering, Manufacturing, and Quality Assurance to represent Validation in teams, with the objective that project quality assurance objectives are met.
1. Prepare and execute CSV and validation deliverables for Mixing and Weighing Complex, Chemistry and Microbiology Laboratory Equipment, Sterilization Complex, DUPLEX Products Complex (DUPLEX container is a two-compartment flexible IV container, stores pre-measured drug and diluent doses separately until administration to extend the shell life with an aseptic filling process).
2. Prepare and execute all phases of software and CSV according to 21 CFR Part 11 and GxP FDA Regulations.
3. Design and execute Validation Plans and Programs for various projects and tasks to improve manufacturing processes and products.
4. Provide guidance and technical decision making for Management and high-level technical personnel regarding GAMP V, ICH, ISPE guidelines, cGMP compliance, regulatory issues, data integrity, validation strategy and quality systems for projects and/or strategic activities.
5. Prepare and present technical investigative reports as required.
6. Formulate recommendations for disposition or other actions related to product nonconformance and field performance issues.
7. Assist in the supervision of specialized contract personnel and outside vendors in the performance of contracted services.
8. Represent Company in contracts with regulatory agencies, including interface with FDA inspectors.
9. Support the engineering team as needed to complete various continuous improvement activities, investigations related to process and batch deviations, customer complaints to meet the “Rate, Quality and Yield” targets for the functional production unit.

10. Highly skilled in generation and execution of PQs and PVs for large and small volume parental solutions.
11. Collaborate with engineering on commissioning activities (FAT/SAT) to ensure compliance with quality objectives and site SOPs.

(01/2015 – 05/2015): Sr. Validation Engineer, Dendreon Biotechnology (Valeant), Seal Beach, CA.
Participated in the development, implementation and adherence to validation test procedures (equipment, utilities, cleaning and process) ensuring products met appropriate regulatory agency validation requirements, internal company standards and current industry practices.
1. Prepared and reviewed validation protocols and final reports (IQ, OQ and PQ).
2. Developed and revised standard operating procedures (SOPs).
3. Assisted with equipment selection and specification.
4. Coordinated the proper approval of plans and protocols.
5. Developed training and ensures implementation of validation execution training.
6. Acted as subject matter expert during regulatory inspections or audits.
7. Monitored validation change control and/or corrective actions.
8. Led contract validation consultants and validation execution by third party.
9. Represented department in cross-functional teams, projects and GXP-related problem resolution.

(03/2014 – 12/2014): Cleaning Validation Engineer III, McNeil Consumer Healthcare Division of Johnson & Johnson, Lancaster, PA.
1. Developed CIP/COP cycles, documents and SOPs and prepared reports under FDA Consent Decree. Monitored the post cleaning validation activities.
2. Demonstrated a passion for cleaning improvement that produced positive financial and operational efficiency results.
3. Executed the CIP/COP and manual cleaning validation activities under FDA Consent Decree. Troubleshooted CIP/COP system failures.
4. Optimized CIP/COP systems including manual processes and CIP/COP equipment. Performed PQ qualification of Girton COP pharmaceutical cabinet washer and Nauta and Simethicone Pumping System CIP cleaning equipment.
5. Executed packaging validation of High Speed Bottle Line in OTC Healthcare Products.
6. Analyzed data, determined results and presented conclusions and recommendations ensuring that projects were implemented in accordance with the agreed scope timelines, policies and procedures.
7. Generated and resolved protocol discrepancies or deviations. Reviewed GxP deliverables including specifications, drawings, procedural documents, master plans, and validation documentation.
8. Authored development and validation protocols, CAPA investigations, Risk Assessments, Standard Operating Procedures (SOP), User Requirement Specifications (URS) and reports.
9. Trained operations staff on protocols, procedures and technical details related to systems or processes.
10. Organized, scheduled and tracked validation projects in order to meet requirements and agreed timelines.

(10/2013 – 12/2013): Cleaning Validation Engineer, Neutrogena Division of Johnson & Johnson, Los Angeles, CA.
1. Executed both CIP (Cleaning In Place) and COP (Cleaning Out of Place) cleaning validation protocols on equipment for liquid/semi solid OTC cosmetic products.
2. Optimized the spray coverage of the automated pharmaceutical Girton pharmaceutical cabinet washers. Performed OQ and PQ qualifications of Girton washers.
3. Performed post cleaning validation monitoring, cleaning cycle development and cleaning validation in cGMP facility.
4. Maintained all documentation pertaining to cleaning cycle development and validation.
5. Participated in cleaning cycle development activities for processing tanks including parameter selection, determining order of operations, troubleshooting, sampling, and data analysis.
6. Coordinated validation execution between all involved departments.
7. Authored development and validation protocols, CAPA investigations, Risk Assessments, Standard Operating Procedures (SOP), User Requirement Specifications (URS) and reports.

(01/2012 – 09/2013): R&D Project Manager, Kaer Biotherapeutics, Escondido, CA.
Developed a new aerosol drug delivery system to deliver effectively the solid phase surfactant/protein aerosols of pure drug to the lung for the ARDS (Acute Respiratory Distress Syndrome).
Aerosol delivery system (solid phase aerosol inhaler) SUPRAER uses compressed air at 60 psi to aerosolize an aqueous solution or suspension containing the active surfactant agent through a twin-fluid injector nozzle. The water from the generated droplets is rapidly evaporated in an IR (Infrared radiation) evaporation chamber to form a solid-phase aerosol that is subsequently concentrated through a patented aerosol concentrator (virtual impactor) and delivered at the output section of the device as a respirable solid-phase aerosol. Use of the aerosol concentrator produces an aerosol output which is comprised of a high concentration of particles in a smaller volume of gas (inhaled air).
Conducted aerosol size measurement of the novel inhaler with diagnostic instruments such as Cascade Impactor and Malvern Laser Diffraction Analyzer (Spraytec).

(07/2009 - 12/2011): Project Manager, Biomechanics International, Cranberry Township, PA.
CFD studies of the airflow, diffusion and settling of aerosol particles in the pulmonary airways (characterization of the aerosol deposition in the respiratory tract, clearance via the mucous, and dissolution from the lung).
Biomechanics injury analyses related to personal injury cases as litigation support for a variety of U.S. law firms.

(01/2007 - 06/2009): Project Engineer, Radrix Systems LLC, Las Vegas, NV
Software and equipment for medical images (X-Ray, CT, MRI) such as DICOM archive distribution systems, PACSFilm (Picture Archiving and Communication Systems), and MDI (Mobile Digital Imaging) Bridge.
Analyzed, redesigned and validated a liquid cooling system in a medical imaging device. The new redesigned cooling system allowed the device to operate at over 150% of previous maximum power resulting in the highest quality images ever.

(05/2004 – 12/2006): Research Scientist, Mechanical Engineering Department, University of Nevada Las Vegas, Las Vegas, NV.
List of completed research projects:
1. Studied the processes in Ceramic High-Temperature Heat Exchangers and Decomposers (CFD study for heat transfer and fluid flow analysis of hydrogen production with Sulfur-Iodine (S-I) cycle).
2. Performed CFD thermal-fluid analysis of passive cooling systems of high concentration photovoltaic solar system.
3. Performed optimization of a gas turbine air inlet cooling system by fogging (a CFD analysis to increase the energy/thermal efficiency).
4. Studied the CFD airflow in a digital reference model of the 17-generation airway bronchial tree.
5. Studied CFD Modeling of Droplet Vaporization in the Quenching Process of the Solar Cadmium Hydrogen Cycle.
6. Lectured for the graduate Computational Methods for Engineers course in Mechanical Engineering Department (MEG445) in spring 2005 and for the undergraduate Finite Mathematics, College Algebra, and Precalculus I courses in the Department of Mathematical Sciences.

(11/2000 - 04/2004): Research Scientist, Spray System Technology Center Laboratory, Carnegie Mellon University, Pittsburgh, PA.
Designed, performed and validated the construction of experimental test systems for heat transfer, fluid mechanics, and spray and aerosol dynamics processes. Generated material and test specifications.
Modeled fluid dynamic behavior and evaporation of various liquid sprays including those used in medical inhalation therapy, electronics cooling, fluid transfer devices and fuel injection.
Analyzed, developed and validated commercial laser-based fluid spray instruments that determine the temperature, size, and velocity of droplets: Rainbow Refractometer, PDPA, PIV, PLIF, Malvern Diffraction Analyzer, and CCD Image Analyzer.
Prepared proposals for government and industrial projects. Initiated new research projects and wrote reports for research contracts and grants.
Taught “Computational Fluid Mechanics” in Spring 2003.
List of completed research projects at Spray System Technology Center:
1. Experimental study of cavitation-enhanced flash-boiling atomization for crude-oil injection into refinery catalytic cracking combustor (ExxonMobil).
2. Alcohol Atomization for Penetration through a Micro-Porous Hose (ExxonMobil Upstream Research Co.).
3. Experimental study of the spray diagnostics of tablet coating sprays for a pharmaceutical unit process (Merck & Co., Inc.).
4. Measurement of medical nebulizers for inhalation therapy spray optimization (Sunrise Medical).
5. Numerical (CFD) and experimental studies of fluid dynamic and transport phenomena of vaporizing sprays to determine the spray characteristics.
6. Numerical CFD studies of inhalation therapy sprays in the human larynx and airway (Grant from Pittsburgh Supercomputer Center).
7. Design of experiment (DOE) and test development for the discharge coefficient measurements of AERx type orifices used in pulmonary drug delivery systems (Aradigm Corporation).
8. Spray nozzle characteristics, process and test developments for airborne respirable dust control equipment in mining industries (NIOSH, National Institute for Occupational Safety and Health)
9. Microfluidic device developments such as microengine, microinjector, and microcooler in MEMS technology (Proposals for DARPA).
10. Drop size, velocity and charge-to-mass ratio measurements of electrosprays for automobile painting (Ford)
11. Analysis of chocolate atomization and spray coating of ice cream cones (Nestle)
12. Effect of Rheology on NanoCrystal Colloidal Dispersions (Elan Drug Delivery, Inc)
13. Drop Formation from Two Impinging Micro Liquid Jets (Mitsubishi Chemical Corp., Japan)

(05/1996 - 11/2000): Assistant Professor, Sakarya University, Engineering Faculty, Environmental Engineering Department, Sakarya, Turkey.
Taught 1) Thermodynamics, 2) Air Pollution Control, 3) Environmental Modelling, 4) Dust Collectors and Application, and 5) Industrial Air Pollution courses. Set up a new air pollutants measurement laboratory including a sampling unit from a government funded project. Conducted measurements of Volatile Organic Components of process exhaust gases in different industries for the emission regulations of Turkish Environmental Protection Agency.

(03/1994 – 04/1996): Project Manager, American Environmental Analytical, Inc., Lincolnwood, IL.
1. Managed the laboratory team in accomplishing analytical testing under EPA regulatory programs and remediation.
2. Developed and validated test methods, executed laboratory test protocols, maintained schedule and cost control.
3. Specialized in the analysis of national emission standards for hazardous air pollutants, solid waste, wastewater for determination of volatile organic compounds (VOC), semi-volatile organic compounds (SVOC), and polychlorinated biphenyls (PCB) using state-of-the-art instruments (HPLC, GC, GC/MS, IC, FTIR).
4. Responsible for maintaining compliance with the National Emission Standards (NESHAPs, CAA, NPDES, CWA, CERCLA).

(08/1989 – 07/1993): Research Scientist and PhD, Mechanical Engineering Department, Technical University of Kaiserslautern, Kaiserslautern, Germany.
Performed CFD simulations and experiments for industrial projects in process engineering, fluid mechanics, and HVAC systems:
1) Efficiency measurements of particulate scrubbers;
2) Two-phase jet flow simulation with consideration of droplet coalescence, breakup, condensation and evaporation in a spray absorber tower;
3) Diesel engine analysis to represent evaporating fuel spray.
4) CFD study of industrial wet scrubbers and conducted measurements using an Optical Particle Counter to determine dust collection efficiency of the wet scrubber.

(10/1987 – 07/1989): Research Scientist, Mechanical Engineering Department, Technical University of Kaiserslautern, Kaiserslautern, Germany.
1. Research Scientist supported by a scholarship from German Academic Exchange Service (Deutscher Akademischer Austauschdienst – DAAD).

(06/1987 – 09/1987): German Language School, Goethe Institute, Manheim, Germany.
2. 4 months German language scholarship from German Academic Exchange Service (Deutscher Akademischer Austauschdienst – DAAD).
3. Attended courses in Intermediate Level I and II German as a Foreign Language.

(06/1985- 02/1987): Teaching Assistant, Sakarya Engineering Faculty, Mechanical Engineering Department, Istanbul Technical University, Sakarya, Turkey.
Recognized for outstanding teaching in Heat Transfer and Thermodynamic courses for three consecutive semesters. Designed a new curriculum for the heat transfer laboratory.

EXPERIMENTAL SKILLS:
Spray and Fluid Mechanics Diagnostics: Phase Doppler Particle Analyzer (PDPA), Particle Image Velocimetry (PIV), Rainbow Spectrometer, Malvern Diffraction Analyzer (Spraytec), CCD Image Analyzer, Planar Laser Induced Fluorescence (PLIF) Analyzer, Kaye Validator

Particle and Aerosol Diagnostics: Particle Characterization, Aerodynamic Particle Sizer, Condensation Particle Counter, Electrospray Aerosol Generator

Material Property Diagnostics: Rheometers; Dynamic Mechanical Analyzer (DMA); Thermal Analyzers (Differential Scanning Calorimetry – DSC, Thermogravimetry - TGA and Thermo Mechanical Analysis - TMA).

Environmental Pollutants Monitoring: HPLC (High Performance Liquid Chromatography), GC (Gas Chromatography), GC/MS (Gas Chromatography/Mass Spectrometry), Ion Chromatography, Fourier Transform Infrared Spectroscopy (FTIR), UV-Vis Spectroscopy.

COMPUTER SKILLS:
• Experience with supercomputer and UNIX; Programming in FORTRAN, Visual BASIC, Python; VBA for EXCEL
• Versatile in CFD, FEA and graphic software’s: KIVA-3V, FLUENT, Icepak, ANSYS/FLOTRAN, ANSYS/Multiphysics, FloVENT, FlowMaster, EnergyPlus, CAESAR II.
• LABVIEW, MATLAB, SIMULINK, MINITAB and SPSS (Statistics) and PC-based software’s (Microsoft Office and Visio; Word, Excel, PowerPoint, Outlook, OneNote, Access, Publisher).
• Air dispersion modeling software’s (AERMOD, CALPUFF, TANKS 4.0).

AWARDS:
• German language scholarship at Goethe Institute in Mannheim, Germany for 4 months (June-Sept. 1987).
• Research Fellowship from the German Academic Exchange Council (DAAD–Deutscher Akademischer Austauschdienst) for 22 months (October 1987 - July 1989).

AFFILIATIONS:
1) 2016-Continue: American Society for Quality (ASQ), USA
2) 2021-Continue: International Society for Pharmaceutical Engineering (ISPE), USA
3) 2002-2006: American Society of Mechanical Engineers International (ASME International), USA
4) 1999-Continue: Institute for Liquid Atomization and Spray Systems (ILASS-America), USA
5) 1987-1993: Association for Aerosol Research (Gesellschaft fur Aersolsolforchung e.V), Germany
6) 1996-2000: Turkish Society of HVAC (Heating Ventilating Air Conditioning) and Sanitary Engineers, Turkey
7) 1983-1987: Turkish Chamber of Mechanical Engineers (TMMOB Makina Mühendisleri Odası), Turkey

LANGUAGES:
Turkish (native), English (fluent), and German (fluent)

BOOK CHAPTER:
Gemci, T. and Chigier, N. (January 2016). “Chapter 7: Atomization, Spraying and Nebulization,” in H. G. Merkus and G. M. H. Meesters (Eds.), “Production, Handling and Characterization of Particulate Materials,” ISBN 978-3-319-20948-7, Berlin - Heidelberg, Springer International Publishing.

JOURNAL PUBLICATIONS:

Gemci, T., Ponyavin, V., Collins, R., Corcoran, T.E., Saha, S.C., and Islam, M.S. (2022). “CFD Study of Dry Pulmonary Surfactant Aerosols Deposition in Upper 17 Generations of Human Respiratory Tract,” Atmosphere, v 13(726), p 1-18.

Islam, M.S., Larpruenrudee, P., Saha, S.C., Pourmehran, O., Paul, A.R., Gemci, T. (2021). “How severe acute respiratory syndrome coronavirus-2 aerosol propagates through the age-specific upper airways,” Physics of Fluids, v 33 (8), 081911.

Islam, M.S., Larpruenrudee, P., Paul, A.R., Paul, G., Gemci, T., Gu, Y., Saha, S.C. (2021). “SARS CoV-2 aerosol: How far it can travel to the lower airways?,” Physics of Fluids, v 33 (6), 061903.

Islam, M.S., Saha, S.C., Gemci, T., Yang, I.A, Sauret, E., Ristovski, Z., and Gu, Y.T. (2019). “Euler-Lagrangian Prediction of Diesel-Exhaust Polydisperse Particle Transport and Deposition in Lung: Anatomy and Turbulence Effects,” Scientific Reports, v 9 (1), p 1-16. https://www.nature.com/articles/s41598-019-48753-6

King, R. (Editor) with Contributors: Talabi, S., Biwalkar, R., Gemci, T., Chang, S., Fischbak, P. (2018). “Advanced Nuclear Technology: Integrated Pressurized Water Reactor (iPWR) Containment Aerosol Deposition Behavior Phase 2a: Technical Basis and Test Plan for Experimental Testing and Computational Fluid Dynamics Analysis,” EPRI Report # 3002010491.

King, R. (Editor) with Contributors: Talabi, S., Biwalkar, R., Redus, K., Gemci, T., Fischbak, P. (2018). “Advanced Nuclear Technology: Integrated Pressurized Water Reactor (iPWR) Containment Aerosol Deposition Behavior Phase 2b: Results and Analysis,” EPRI Report # 3002013032.

Islam, M.S., Saha, S.C., Gemci, T., Yang, I.A., Sauret, E., and Gu, Y.T. (2018). “Polydisperse Microparticle Transport and Deposition to the Terminal Bronchioles in a Heterogenous Vasculature Tree,” Scientific Reports, v 8 (1), p 1-9.


Islam, M.S., Saha, S.C., Sauret, E., Gemci, T., and Gu, Y.T. (2017). “Pulmonary Aerosol Transport and Deposition Analysis in Upper 17 Generations of the Human Respiratory Tract,” Journal of Aerosol Science, v 108, p 29-43.

Islam, M.S., Saha, S.C., Sauret, E., Gemci, T.,Yang, I.A., and Gu, Y.T. (2017). “Ultrafine Particle Transport and Deposition in a Large Scale 17-Generation Lung Model,” Journal of Biomechanics, v 64, p 16-25.

Gemci T., Ponyavin, V., Chen, Y., Chen, H., and Collins, R. (2008). “Computational Model of Airflow in upper 17 Generations of Human Respiratory Tract,” Journal of Biomechanics, Volume 4, Issue 9: 2047-2054.

Allen, G.M., Shortall, B.P., Gemci, T., Corcoran, T.E., and Chigier, N. (2004). “Computational simulations of airflow in an in vitro model of the pediatric upper airways,” Journal of Biomechanical Engineering, v 126, n 5, October, 2004, p 604-613.

Gemci, T., Yakut, K., Chigier, N., and Ho, T.C. (2004). “Experimental study of flash atomization of binary hydrocarbon liquids,” International Journal of Multiphase Flow, v 30, n 4, April, 2004, p 395-417.

Gemci, T., Yakut, K., Chigier, N., and Ho, T.C. (2004). “Flash atomization of water/acetone solutions,” Atomization and Sprays, v 14, n 5, September, 2004, p 459-475.

Gemci, T., Shortall, B., Allen, G.M., Corcoran, T.E., and Chigier, N. (2003). “A CFD study of the throat during aerosol drug delivery using heliox and air,” Journal of Aerosol Science, v 34, n 9, Sep 1, 2003, p 1175-1192.

Gemci, T., Corcoran, T.E., and Chigier, N. (2002). “ A numerical and experimental study of spray dynamics in a simple throat model,” Aerosol Science and Technology, v 36, n 1, 2002, p 18-38.

Gemci, T. and Ozturk, A. (1998). “Exergy analysis of a sulphide-pulp preparation process in the pulp and paper industry,” Energy Conversion and Management, v 39, n 16-18, Nov-Dec, 1998, p 1811-1820.

Gemci, T. and Ebert, F. (1992). “Prediction of the particle capture efficiency based on the combined mechanisms (turbulent diffusion, inertial impaction, interception, and gravitation) by a 3-D simulation of a wet scrubber,” Journal of Aerosol Science, v 23, n SUPPL 1, 1992, p S769-S772.

INVITED LECTURES:
Chigier, N. and Gemci, T. (2003). “A Review of Micro Propulsion Technology,” Invited paper for AIAA 41st – Aerospace Sciences Meeting, Reno, Nevada, 6-9 January 2003.

Gemci, T. and Chigier, N. (2003). “Electrohydrodynamic Atomization For MEMS Combustion Engines,” AIAA 41st – Aerospace Sciences Meeting, Reno, Nevada, 6-9 January 2003.

Chigier, N. and Gemci, T. (2002). “Problems and Challenges in the Development of Micro-propulsion Devises,” Proceedings of the 42nd Israel Annual Conference on Aerospace Sciences, Tel Aviv and Haifa, Israel, February 2002.

SELECTED CONFERENCE PUBLICATIONS:

Gemci, T., V. Ponyavin, Y. Chen and R. Collins (2005) “Oscillatory Flow in an Anatomically Realistic 17-Generation Human Bronchial Airway Model.” In: 10th Jubilee National Congress on Theoretical and Applied Mechanics, Proceedings Volume II, eds. Ya Ivanov, E. Manoach, and R. Kazandjiev, Prof. M. Drinov Academic Publishing House, Sofia, Bulgaria, pp 107-119.

T. Gemci, G. Allen, B. Shortall, T. Corcoran, and N. Chigier (2003). “Droplet Dynamics, Fluid Flow and Particle Deposition for Pulmonary Drug Delivery to Pediatric Patients,” ICLASS-2003, The 9th International Conference on Liquid Atomization and Spray Systems, Sorrento, Italy, 13-17 July 2003.

T. Gemci, N. Chigier, and J.A. Organiscak (2003). “Spray Characterization for Coal Mine Dust Removal,” ICLASS-2003, The 9th International Conference on Liquid Atomization and Spray Systems, Sorrento, Italy, 13-17 July 2003.

T. Gemci, B. Shortall, T.E. Corcoran, and N. Chigier (2002). “Deposition Study of an Inhalation Therapy Spray in a Cadaver Throat,” ILASS-America 2002, 15th Annual Conference on Liquid Atomization and Spray Systems, Madison, WI, pp. 241-245, 14-17 May 2002.

T. Gemci, R. Hitron, and N. Chigier (2002). “Measuring Charge-To-Mass Ratio of Individual Droplets Using Phase Doppler Interferometry,” ILASS-America 2002, 15th Annual Conference on Liquid Atomization and Spray Systems, Madison, WI, pp. 241-245, 14-17 May 2002.

T. Gemci, N. Chigier, P.P. Godpole, and P. Strickland (2002). “Spray Characterization for Fluidized Bed Granulation Processes,” ILASS-Europe 2002, 18th Annual Conference on Liquid Atomization and Spray Systems, Zaragoza, Spain, 9-11 September 2002.

T. Gemci, R. Hitron, and N. Chigier (2002). “Determination of Individual Droplet Charge in Electrosprays from PDPA Measurements,” ILASS-Europe 2002, 18th Annual Conference on Liquid Atomization and Spray Systems, Zaragoza, Spain, 9-11 September 2002.

T. Gemci, B. Shortall, T.E. Corcoran, and N. Chigier (2002). “Deposition of Particles in the Upper Respiratory Tract,” ILASS-Europe 2002, 18th Annual Conference on Liquid Atomization and Spray Systems, Zaragoza, Spain, 9-11 September 2002.

N. Chigier and T. Gemci (2002). “Problems and Challenges in the Development of Micro-propulsion Devises,” Proceedings of the 42nd Israel Annual Conference on Aerospace Sciences, Tel Aviv and Haifa, Israel, February 2002.

T. Gemci, K. Yakut, N. Chigier, and T.C. Ho (2001). “Cavitation Enhanced Flash Atomization of Hydrocarbon Liquids,” ILASS-Europe 2001, 17th Annul Conference on Liquid Atomization and Spray Systems, Zurich, Switzerland, 2-6 September 2001.

T. Gemci, T.E. Corcoran, K. Yakut, B. Shortall, and N. Chigier (2001). “Spray Dynamics and Deposition of Inhalation Medications in the Throat,” ILASS-Europe 2001, 17th Annul Conference on Liquid Atomization and Spray Systems, Zurich, Switzerland, 2-6 September 2001.

T. Gemci, K. Yakut, N. Chigier, and T.C. Ho (2001). “Cavitation and Flash Boiling Atomization of Water/Acetone Binary Mixtures,” ILASS-Americas 2001, 14th Annual Conference on Liquid Atomization and Spray Systems, Dearborn, MI, pp. 241-246, 20-23 May 2001.

T. Gemci, T.E. Corcoran, K. Yakut, B. Shortall, and N. Chigier (2001). “Numerical Simulation of Particle and Air Velocity Fields in A Model of A Cadaver Throat,” ILASS-Americas 2001, 14th Annual Conference on Liquid Atomization and Spray Systems, Dearborn, MI, pp. 131-136, 20-23 May 2001.

T. Gemci, T.E. Corcoran, and N. Chigier (2000). “A Numerical Study of Inhalation Therapy Sprays in the Human Throat Including Comparisons with Experimental Results,” Symposium on High Performance Computing, 2000 Advanced Simulation Technologies Conference, Washington, DC, pp. 60-65, 16-20 April, 2000.

T. Gemci, T.E. Corcoran, and N. Chigier (2000). “Dispersion and Deposition of Inhalation Therapy Sprays in the Larynx and Trachea Using Experimental and Numerical Methods,” ICLASS-2000, The 8th International Conference on Liquid Atomization and Spray Systems, Pasadena, CA, 16-20 July, 2000

T. Gemci, J. Hom, and N. Chigier (2000). “Experimental Study of Evaporating Full-Cone Spray by Determining Droplet Temperature with Rainbow Refractometry and Comparing with Numerical Simulation,” ICLASS-2000, The 8th International Conference on Liquid Atomization and Spray Systems, Pasadena, CA, 16-20 July, 2000.

T. Gemci, J. Hom, and N. Chigier (2000). “Simulation of Evaporating Spray and Comparison with Droplet Temperature Measurement Obtained by Rainbow Refractometer”, Proceedings of ASME Fluids Engineering Division, ASME International Congress Proceedings 2000, November 5-11, Orlando, FL, FED-Vol. 253, pp. 59-66.

T. Gemci and F. Ebert (1993). “Welche Mechanismen spielen bei der Staubabscheidung in einem Düsenwäscher eine Rolle? Ergebnisse einer Computer-Simulation,” GVC-Gesellschaft Verfahrenstechnik und Chemieingenieurwesen-Fachausschuss « Partikelabscheidung-Abgasreinigung”. Cologne, Germany, 19-20 April 1993.

T. Gemci and F. Ebert (1992). "Dust Collection Efficiency of a Wet Scrubber Determined by a 3-D Simulation of the Turbulent Multiphase Flow," in ILASS-EUROPE-92 (M. Afghan, ed.), pp. 197-204, September 30-October 2, 1992, Koninklijke/Shell Laboratorium, Amsterdam, The Netherlands.

COMPLETED R&D SUPPORT:
(1997- 1999): Air Pollutants Measurement Laboratory (Government Project: DPT – The State Planning Organization of Turkish Republic).
Sakarya İli İçin Hava Kirliliği Envanteri Çıkarılması ve Hava Kalitesi Modellerinin Yapılması
Aim: Set up a new air pollutant measurement laboratory including a GC with the air sampling unit. Conduct measurements of Volatile Organic Components from process exhaust gases in different industries for the emission regulations of the Turkish Environmental Protection Agency.

Sakarya Üniversitesi’nde Devlet Planlama Teşkilatı projesi çerçevesinde bir hava kirleticileri ölçüm laboratuvarı kurulmuştur. Laboratuvar Gaz Kromatografi ve hava örnekleme ünitesi, havadaki polar ve polar olmayan toksik uçucu organik bileşiklerin analiz ve ölçüm test kitlerinden oluşmuştur. Türkiye Çevre Bakanlığının emisyon düzenlemeleri için Sakarya’daki farklı endüstrilerde proses egzoz gazlarından Uçucu Organik Bileşenlerin ölçümleri ve hava kalitesi modellemeleri yapılmıştır. Bu proje çerçevesinde 3 tane lisansüstü tez tamamlanmıştır.
Budget: 60000 TL

(Jul 2001 – Dec 2002): Measuring Size Classified Charge to Mass Ratio in Rotating Bell Atomizer (Industrial Project for Ford Motor Company) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Drop size, velocity and charge-to-mass ratio measurements of electrosprays for automobile painting. Spray painting is controlled situation in which electrostatic spraying of earthed objects of well-defined geometries in used. Spray distance, angle, and charge levels can be adjusted for optimum coating.
Project Team: Prof. N. Chigier, Dr. R. Hitron, and Dr. T. Gemci at Carnegie Mellon University.
Budget: 200000 USD

(Jan 2001 - Jul 2004): Boiling and Cavitation Enhanced Atomization of Binary Hydrocarbon Liquids (Industrial Project for ExxonMobil Research and Engineering Co.) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Experimental study of cavitation enhanced flash-boiling atomization for crude-oil injection into a refinery catalytic cracking combustor. Flash-boiling atomization can be initiated when a pure liquid (for example crude-oil), a liquid with dissolved gas, or a liquid mixture is subjected to sufficient superheating (boiling) or pressure reduction (cavitation) that causes bubble formation. The subsequent growth of the bubbles drives the atomization process. This process may be used to enhance atomization where the conventional pressurized liquid injection cannot achieve the desired fine spray. This is especially true for injecting heavy hydrocarbons or oils subject pressure and/or propellant gas constraints. Such is the case, for instance, in the fluid catalytic cracking process which is the primary conversion process in petroleum refining.
Project Team: Prof. N. Chigier, Dr. T. Gemci, Dr. R. Hitron, and K. Yakut at Carnegie Mellon University.
Budget: 500000 USD

(Sep 2000- Dec 2001): Analysis and Optimization of Coating Atomization in a Pan Coating Device (Industrial Project for Merck & Co., Inc.) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Experimental study of the spray diagnostics of tablet coating sprays for a pharmaceutical unit process. Additives in the coating fluids cause their spray to be considerably different than their Newtonian analogs (glycerol). The polymeric binder (cellulose) used in the coating adds to the viscosity but also makes the fluids more elastic, or non-Newtonian. Choice of nozzle based on nozzle characterization with Newtonian fluids may underestimate the drop sizes and misrepresent the spray characteristics.
The spray characterizations of Newtonian fluids corresponding to the viscosity values of the non-Newtonian coating fluids (OPADRY and OPADRY II) were investigated by imaging, patternator, and drop size measurements. The influence of the pulsing of the peristaltic pump on the gross characteristics of the spray was investigated by imaging and drop size measurements. This project’s final phase involves the quantitative characterization of the two coating sprays (OPADRY and OPADRY II) and details the spray images and the ensemble drop size measurements of these two coating fluids at different operating conditions and compares them with the Newtonian fluids (glycerol solutions).
Project Team: Prof. N. Chigier, Dr. T. Gemci and Prof. L. Walker at Carnegie Mellon University.
Budget: 250000 USD

(Jan 2001 – Dec 2001): Optimization of Medical Nebulizers (Industrial Project for Sunrise Medical) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Measurement of medical nebulizers/inhalers for the optimization of inhalation therapy sprays. Phase Doppler Particle Analyzer is used for the measurement of the inhalation therapy sprays. Spray particle size distribution of delivered aerosols and the total mass of drug delivered from the inhaler/nebulizer are important determinants of pulmonary deposition and response to inhalation therapy. Optimization of inhalation therapy sprays is important because small particles (<2 micrometer) deposit mainly in the alveolar region and are probably the most apt to act systemically, whereas the particle in the size range 2–6 micrometer are be best suited to treat the central and small airways.

The Phase Doppler Particle Analyzer (PDPA) gives dynamic measurements of particle size, velocity, number density, and volume flux; is accurate and reliable in demanding environments; includes easy-to-use software for measurement, control, and data analysis; and does not disturb the measurement environment. The Phase Doppler Method is based upon the principles of light scattering interferometry. Measurements are made at a small, non-intrusive optical probe volume defined by the intersection of two laser beams. As a particle passes through the probe volume, it scatters light from the beams and creates an interference fringe pattern. A receiving lens strategically located at an off-axis collection angle projects a portion of this fringe pattern onto several detectors. Each detector produces a Doppler burst signal with a frequency proportional to the particle velocity. The phase shift between the Doppler burst signals from the different detectors is proportional to the size of the spherical particles. The Phase Doppler method requires no calibration because the particle size and velocity are dependent only on the laser wavelength and optical configuration.

Project Team: Prof. N. Chigier, Dr. T. Gemci and B. Shortall at Carnegie Mellon University and Dr. T. Corcoran at Pulmonary Medicine Department in University of Pittsburgh Medical Center (UPMC).
Budget: 100000 USD

(Sep 2000 – Dec 2000): Discharge coefficient measurements of AERx type orifices (Industrial Project for Aradigm Corporation) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Determine the discharge coefficients as a function of Reynolds number for AERx type nozzles which are used in pulmonary drug delivery systems. Discharge coefficients can be directly determined from the pressure drop across each nozzle orifice and the associated mass flow rate. For liquid jets emerging into atmospheric pressure, only the upstream liquid pressure is required to be measured. The Reynolds number varies between 20 and 200. Ten different nozzle orifices were tested to find out the best nozzle shape with the highest discharge coefficient and lowest pressure loss.
Project Team: Prof. N. Chigier and Dr. T. Gemci at Carnegie Mellon University.
Budget: 50000 USD

(Jan-Dec 2003): Measurement of Spray Nozzle Parameters and Water Droplet Properties (Government Project for Pittsburgh Research Laboratory of NIOSH, National Institute for Occupational Safety and Health) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Spray nozzle characteristics for airborne respirable dust control in mining industries. Dust scrubbing using water sprays is one of the most common techniques for airborne respirable dust control in the mining industry. Measurement of spray characteristics such as drop size and velocity using state-of-the-art laser instruments (Phase Doppler Particle Analyzer) will provide detailed information for a better understanding of wet scrubbing mechanisms such as inertial impaction, interception, and turbulent diffusion. All previous wet scrubber performance calculations were based on measurements of dust size and concentration as a function of water flow rate, water pressure, and average drop size. The real spray process undergoes dynamic changes so that it is necessary to determine spray characteristics such as drop size and velocities in both radial and axial directions.
Project Team: Prof. N. Chigier and Dr. T. Gemci at Carnegie Mellon University.
Budget: 185000 USD

(Apr-Sep 2001): Analysis of Chocolate Atomization and Spray Coating of Ice Cream Cones (Industrial Project for Nestle R&D Inc., Ohio) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Spray characterization of the chocolate coating process to prevent sogginess in ice cream cones.
Project Team: Prof. N. Chigier, Dr. T. Gemci, and K. Yakut at Carnegie Mellon University.
Budget: 75000 USD

(Feb-Dec 2002): Drop Formation from Two Impinging Micro Liquid Jets (Industrial Project for Mitsubishi Chemical Corporation, Japan) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Control and characterization of the physical drop formation mechanisms including the jet impingement of two liquid jets, mixing, and breakup of the combined mixed jet, and the consequent drop formation.
Project Team: Prof. N. Chigier, Dr. T. Gemci, and B. Shortall at Carnegie Mellon University.
Budget: 150000 USD

(2002): Spray Validation Measurements for Control Vision Instrument (Industrial Project for ExxonMobil Research & Engineering, Inc) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Validation of water spray atomization for the suppression and control of the accidentally released gaseous pollutants with water spray mist.
Project Team: Prof. N. Chigier, Dr. T. Gemci, and G. Allen at Carnegie Mellon University and W. G. Coulombe at Desert Research Institute in University of Nevada.
Budget: 200000 USD

(Aug 2002 – Jul 2003): Effect of Rheology on NanoCrystal Colloidal Dispersions (Industrial Project for Elan Drug Delivery, Inc) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Understanding the effect of the rheology of NanoCrystal colloidal dispersions in combination with various process conditions on several resultant spray characteristics.
Project Team: Prof. N. Chigier, Dr. T. Gemci, and G. Allen at Carnegie Mellon University.
Budget: 125000 USD

(Mar 2002- Feb 2003): Alcohol Atomization for Penetration through a Micro-Porous Hose (Industrial Project for ExxonMobil Upstream Research Co.) at Spray Systems Technology Center in Mechanical Engineering Department of Carnegie Mellon University, Pittsburgh, PA, USA.
Aim: Create an ultra-fine spray by atomizing liquid alcohol to penetrate through a micro-porous hose.
Project Team: Prof. N. Chigier and Dr. T. Gemci at Carnegie Mellon University.
Budget: 95000 USD

(Jun 2005 – Dec 2006): Development of Mesh Refinement and Adaptation Schemes to Streamline Mesh Development (Government Project for US Army Research Laboratory) at Mechanical Engineering Department of University of Nevada Las Vegas, Las Vegas, NV.
Aim: Many finite element meshes do not have adequate resolution to capture the localization phenomenon due to lack of a priori knowledge about their locations. The CPU time is extremely large when the fine meshes or more elements are used in order to obtain the good solutions. A key component in the analysis of complex systems is mesh generation or refinement.
Project Team: Prof. Y. Chen and Dr. T. Gemci at University of Nevada Las Vegas.
Budget: 135000 USD

(2016-2020): Experimental Verification of Post-Accident Integrated Pressurized Water Reactor (iPWR) Aerosol Behavior (Government Project for Energy Power Research Institute (EPRI) R&D Project).
Phase 1 (2016-2017), Phase 2 (2017-2018), and Phase 3 (2018-2020)
Aim: The purpose of the R&D project is to describe a set of experiments that investigate aerosol behavior under simulated Integrated Pressurized Water Reactors (iPWRs) accident conditions. The experiments will simulate a design configuration in which the containment vessel wall is cooled, and hence creates a thermal and steam gradient, which drive thermo- and diffusion-phoretic particle deposition forces in a lateral direction toward the containment vessel.
Project Team: Prof. P. Fishback, Dr. S. Talabi, and Dr. T. Gemci at Carnegie Mellon University & Pittsburgh Technical.
Budget: 1 Million USD Phase 2A and 1 Million USD Phase 2B

(2019-2020): Regulatory Support for Advanced Light Water Reactor Deployment: Advanced Boiling Water Reactor Source Term Reduction (Government Project for Department of Energy (DOE) R&D Project)
Collaborators: EPRI, GE, Carnegie Mellon University, Pittsburgh Technical
Aim: The objective of this project is to explore the development of a set of recommendations to improve the characterization of post-accident radionuclide particle source-term for advanced Boiling Water Reactors (BWR), which include the Advanced Boiling Water Reactor (ABWR), the Economic Simplified Boiling Water Reactor (ESBWR), and the recently-advertised BWR/X. The potential recommendations will include the various activities required to develop the technical basis that may support possible regulatory amendments to source terms.
Project Team: Prof. P. Fishback, Dr. S. Talabi, Dr. T. Gemci, Rohan Biwalker at Carnegie Mellon University & Pittsburgh Technical.
Budget: 300000 USD