Scott E. Mackler
Principal Consultant

Mr. Mackler has 30 years of industry experience including corporate management, project planning and basis of design development, commercialization of new products, applications for process isolation and mini-environments, construction claims arbitration, vendor/contractor identification and qualification, RFP/RFQ preparation, project financial justification, site selection services and third party design reviews. Mr. Mackler performs industrial sales and marketing due diligence on behalf of the investment banking community and facilities evaluation and assessment on behalf of real estate development firms such as Trammel Crow.

Mr. Mackler has served as General Manager for Clestra Cleanroom in the US, and is founder and principal of Cleanroom Consulting, LLC, a firm specializing in contamination control industry services including cGMP cleanroom design and controlled environment applications, troubleshooting, assessment and corrective actions for FDA validatable critical facilities, new product introductions for the contamination control marketplace, merger and acquisition advisement, outsourcing services and industrial sales & marketing consultation including customer retention strategies. Prior to Clestra, Mr. Mackler worked for Allied Signal and Union Carbide in areas related to advanced extraction and separations technology, and he holds a BSME from Rensselaer Polytechnic Institute and the MBA degree from the University of Houston.

At Cleanroom Consulting, Mr. Mackler has led the basis of design (conceptual design phase) teams for projects in the life sciences (human blood products-based therapeutics and autologous cell transplant) and is currently acting as owner representative for a spinal nerve cell therapy center as well as being actively engaged in biotechnology projects for tissue culture applications and for the manufacture of therapeutic proteins via microbial expression systems and mammalian cell culture. Mr. Mackler also authored a strategic marketing and product development plan (“stage/gate” process) for a revolutionary new enabling technology for ELISA (enzyme linked immunoassay) testing. Mr. Mackler has provided cleanroom compatibility testing and recommended actions to semiconductor inspection tool manufacturers. He has provided on-site consultation to cleanroom contractors performing work at DuPont (semiconductor wafer fab pilot project), Lucent (fiber optics cleanrooms) and at Balazs Labs (airborne molecular contamination laboratories) as well as for new nanofabrication facilities, precision cleaning and verification facilities, high bay assembly cleanrooms, and has authored Cleanroom User Requirements Specifications and Cleanroom Facility Functional Specifications for a major control systems provider. Mr. Mackler has also recently completed several cleanroom projects for Eastman Kodak Company and is a Certified Lean Six Sigma Green Belt.

Mr. Mackler also provides contamination control consultation and environmental assessment - including recommended actions – to a number of biotechnology companies, medical device injection molders, photolithographic stent manufacturers, and to the world's leading manufacturer of high tech filtration products in support of their "Clean Team" facilities initiatives. Mr. Mackler has been a member of the Licensing Executives Society and serves on the Editorial Advisory Boards of A2C2, the Journal of Contamination Control, American Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract manufacturing, as well as Pharmaceutical Formulation & Quality.

Professional Associations
o Rochester High Tech Business Council
o Rochester Engineering Society, Inc.
o Parenteral Drug Association
o ASHRAE
o International Society of Pharmaceutical Engineers
o International Society for Cell Therapy
o Semiconductor Equipment and Materials International
o Institute of Environmental Sciences and Technology
o US-Israel Biotechnology Council
o AVS Science & Technology Society
o New York Biotechnology Association

List of Publications:

Modular Design & Construction, Part I: Project Planning & Design, Part 2: Installation & Maintenance. BioPharm, September/October 1992

Clinical Production Facilities; Delivery, Design, Operating & Regulatory Considerations, with Stephen W. Fitzpatrick, Ph.D.
Pharmaceutical Technology, September 1995

Current Issues in the Design of Production Facilities for Cell & Gene Therapy. Genetic Engineering News, June 1996

Project Planning & Basis of Design for cGMP Cleanrooms, Parts 1 & 2. A2C2, The Journal of Microcontamination Detection & Control, May/June 1998

The Surprising Advantages of Modular Cleanrooms, with Patrick Boyle, CPA. A2C2, The Journal of Microcontamination Detection & Control, November 1998

The Case for Design/Build Cleanroom Facilities Delivery. A2C2, The Journal of Microcontamination Detection & Control, November 1999

Barrier Isolation Technology: Facilities Update.
Pharmaceutical Technology, February 2000

Barrier Isolation Technology Can Improve Life Sciences Cleanroom Applications. American Pharmaceutical Review, November 2002

Environmental Monitoring: A Product of your Environment, Pharmaceutical Formulation & Quality, June/July 2003

E-mail: sem @ cleanroom-consulting.com


Michael C. Rexine
Consultant

Michael Rexine has 15 years of cleanroom industry experience in all phases of advanced facility project delivery and including cost estimating, contract document preparation and scheduling; spatial, architectural, mechanical and electrical systems planning and design; equipment design, manufacturing, arrangement and installation; and project management, procurement and execution. He has prepared hundreds of cleanroom and laboratory project reviews, estimates, schedules, preliminary designs, equipment selections, and audits. Mr. Rexine has served as Business Development Manager and Sales Engineering and Estimating Manager for Clestra Cleanroom and with Laboratory Safety Services. Mr. Rexine holds a Bachelor of Science Degree in Civil Engineering from Clarkson University.

Mr. Rexine has provided cleanroom facility consulting to the semiconductor, biotech, medical device, cleanroom contracting, and controls industries primarily for design-build project delivery applications. He has prepared cleanroom facility programming documents, specifications and designs; HVAC analysis, design and selection; and contamination control, facility design, construction and operations audits. Recently, Mr. Rexine has prepared design-build cleanroom facility designs for Lucent Technologies and Semiconductor Diagnostics.




Robert J. Pellizzi
Consultant

Mr. Pellizzi has worked in the area of electronic and medical device manufacturing for 35 years in a variety of positions including manufacturing production engineer, supervisor, department manager and senior manager. Responsibilities have included project/business management, supervisory activities, process and system analysis, talent development and mentor.

During a stint as Vice President, Operations of Neuromed, Inc., a firm specializing in implantable spinal cord stimulators, Mr. Pellizzi re-wrote the manual for all FDA-regulated processes resulting in significant cost savings. Later, as a private consultant to the pharmaceutical industry, he designed and built a cleanroom manufacturing facility to produce Albuterol, a drug used to treat asthma. Most recently, Mr. Pellizzi worked for Cordis Corporation, a Johnson & Johnson company producing catheters used to diagnose and treat heart disease, performing various roles including production manager and project manager. He holds both a BS degree and an MBA from Barry University in Miami, FL.

In various positions at Cordis Corporation, Mr. Pellizzi led projects for the validation of Cleanroom and Manufacturing facility environmental control, and validation of the cleanroom cleaning process, both of which resulted in cost savings of over 23%. In addition, he developed several training programs concerning GMP’s, Workstation Practices, Self-Managed Improvement teams, and Laser Operation Training.

List of Publication/Presentations

Developing a Successful Cleanroom Cleaning and Maintenance Program, Medical Device and Diagnostic Industry, February, 1992

Federal Standard 209E: Plan for Change, Medical Device and Diagnostic Industry, February, 1993

Using Teamwork to meet GMP/ISO from Idea to Complaint File, Published in Conference Proceedings, at MDDI-East, January, 1995

TQM: What is Reality?
Cleaning the Cleanroom
Presented at the June, 1992 Medical Design & Manufacturing Conference, New York

Cleanroom & Controlled Environments: What is Needed? What is Recommended?
Self-Managed Work Groups: A Formula for Success
Presented at the May, 1994 Medical Design & Manufacturing Conference, New York

Facilitated a Meet the Industry Expert segment at the May, 1999 MDDI Conference in New York.



James F. Smith
Consultant

Cleanroom Systems (formally Clestra Cleanroom) Syracuse, NY

Critical Environments Business Unit Manager

By focusing the business unit on the OEM accounts and expanding customer relationships to the level of partnerships, the business unit yearly revenue grew substantially. Created an engineering team to review drawings and manufacturing processes, was able to achieve a reduction in product cost while increasing the productivity of the manufacturing line. Provided customer design improvement and design support to customer specifications. Proved design concepts with proto-type. Successfully introduced new environmental control products and concepts into the OEM semiconductor supplier market. Provided substantial customer support for products and for final acceptance of custom products.

Duties included -
Manage Business Unit for OEM / Mini Environments (HVAC) products and accounts, manage department personnel including performance reviews and training. Create, implement and adhere to business plan. Manage budget, P&L, cost estimating, final pricing and cost/margin. Resolve customer technical service issues. Perform sales function including researching and contacting new leads / opportunities. Present Sales Forecast and conduct market research and market analysis.

Prior Experience
As Military Specialty Equipment Technician, Chief Warrant Officer US Army, managed the operation of an environmental control maintenance & repair facility.

Education
Rochester Institute of Technology Rochester, NY
Bachelor of Science in Mechanical Engineering , May 1994
State University of New York, College of Technology at Alfred
Associate in Applied Science in Air Conditioning Engineering Technology, May 1992



Martin Ehlers
Mr. Ehlers dynamic business career in marketing and sales has had him working primarily with leading corporations in the medical device industry. Management experience in marketing, sales, planning, marketing research, and product management disciplines conveys a keen understanding of the spectrum and interface of business activities.

EDUCATION
MBA, Syracuse University
MS (ABC) Nutrition Science, University of Tennessee
MS, Animal Science, University of Tennessee BS, Biology, Tusculum College.