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Protecting the provider, the patient and the environment

Henry (Hank) Rahe
Technical Advisor

Education

• B.S.I.M., 1966, Purdue University
  
• M.S.E., 1971, Purdue University

Work Experience

• Containment Technologies Group, lnc. (1994-Present)
• Eli lilly and Company (1966-1993)

Mr. Rahe has over thirty years of experience in the pharmaceutical industry, as well as four years in academia. Experience includes both management and technical assignments. Areas of experience include primary (bulk) manufacturing, solid dosage, parenteral, capsules, cosmetics, injection molding, and engineering support. He has supported new product launch teams from a facility prospective and possesses a good working knowledge of good manufacturing practices (cGMP).

He has worked for extended periods of time In Puerto Rico, England, France, Germany, and Italy.

Mr. Rahe is a recognized expert in the area of containment of potent compounds and advanced aseptic processing. He has extensive experience in the application of barrier / isolation technology in all facets of pharmaceutical operations.

Professional Organizations

• International Society of Pharmaceutical Engineers
  Board of Directors - President
• CleanRooms
  Editorial Advisory Board
• Parenteral Drug Association
  Member

Detail Of Work Experience

Containment Technologies Group, Inc. (1994 - Present)
Technical Advisor - Developed the MIC (Mobile Isolation Chamber) for providing Class I00 conditions for Pharmacy manipulation of sterile products

Eli lilly and Company (1966 -1993)

• Manager Environmental Engineering - responsible for development of containment technology for potent compounds and advanced aseptic processing
• Senior Engineering Consultant - responsible for US., Canada, Puerto Rico, and Europe new facility design and start-up
• Manager U.S, Capsule Operations - responsible for operations and engineering development - heavy customer service involvement
• Manager Performance Improvement Engineering - U.S. multi-plant staff responsible for efficiency improvement for non-production operations
• Manager U.S. Production Operations Elizabeth Arden - responsible for operations and engineering
• Consultant European Operations Pharmaceutical and Cosmetics - responsible for improvement of quality and efficiency within multiple plant site operations

Technical Experience

• Developed and implemented the containment evaluation technique to define and prioritize containment issues within a process or facility. This has led to cost effective, customer oriented solutions to major containment problems.
• Developed and published a hierarchy of containment technologies that defines the level of effectiveness, as well as cost implications of the application of the technology
• Developed and implemented a mobile microenvironment system for process of pharmaceuticals in cGMP quality facilities
• Developed a unit operations approach to containment for dry dosage pharmaceutical operations
• Developed and proposed through a number of societies and working groups the basic definitions for the components of microenvironments
• Implemented process scheduling techniques for facility producing over six hundred products
• Utilizing queuing theory, designed and installed packaging line
• Utilizing line balancing techniques, eliminated bottlenecks from packaging lines

• Chemical pilot plant, developed concept and supported implementation of dispensing, reactor charging, reactor unloading, dryer loading and unloading, and final packaging
• Dispensing of dry solid potent compounds, aseptic and non-aseptic materials
• Sampling of potent materials from incoming material and process material for laboratory testing
• Laboratory testing of potent compounds from sample preparation to actual testing of equipment
• Developed sterility testing suite design which does not require half suit transfers and utilizes transport system allowing movement of product and materials through the unit
• Dry dosage form facilities, including dispensing, granulation, drying, sizing, compression, capsule filling, and packaging
• Development facilities for dry dosage forms, oil unit operations
• Cephalosporin development facility
• Chemical large scale manufacturing, including reactor charging, dryer unloading, size reduction and final packaging
• Bio-technology facility, including product separation, freeze drying, sampling, and final packaging

Publications And Presentations

• "Barrier / Isolation Technology Applications for Solid Dosage", NIIGATA Engineering Conference, Tokyo, Japan, October 1996
• "Barrier/lsolation Technology Applications for Pharmaceutical Product Development" America Association of Pharmaceutical Scientist - Annual meeting, Seattle, WA - October 1996
• Round Table Discussion Leader for Barrier / Isolation Technoloqy In the Pharmacy Environment, American Society of Health Care Pharmacist - Home Health Division 1996 Annual Meeting, Orlando, FL, July 1996
• "Barrier / Isolation Technology for Advanced Aseptic Processing" Invited Speaker by Dr. Kenneth Avis, Pharma Tech Conference, San Juan, Puerto Rico, June 1996
• ISPE /FDA Conference, Canberra, Australia, May 1996
• "The Mobile Isolation Chamber: A Cleanroom Alternative" CleanRooms East, Boston, MA, April 1996
• "Barrier / Isolation Technology for Containment and Advanced Aseptic Processing" Midwest Chapter Meeting with the FDA, St. Louis, MO, February 1996
• "Barrier / Isolation Technology" ASHRAE Meeting Presentation, Atlanta, GA, February 1996
• "Advanced Barrier / Isolation Technoloqy", article CleanRooms Magazine, Volume 10 Number 1, January 1996
• Advanced Barrier / Isolation Conference, ISPE Co-Chairmen, Rockville, MD, December, 1995
• "Defining Air Quality Requirements: A Cost / Value Approach" article CleanRoom Magazine, Volume 9 Number 11, November 1995
• Barrier / Isolation Technology, ISPE Presentation, Raleigh, NC, October 1995
• "Class I00 Conditions", Indiana Society of Hospital Pharmacist NewsLetter, July/ August 1995
• Containment of Potent Compounds, ISPE Presentation, East Rutherford, NJ June,1995
• CleanRooms East 95', Presentation, Baltimore, MD, April, 1995
• PDA SPRING MEETING, Discussion Leader "Handling Potent Aseptic Products" San Francisco, CA, March 1995
• "Mobile Manufacturing Systems, Pharmaceutical Engineering Response to the New Health Care lndudusty" article Pharmaceutical Engineering, May/June 1994; coauthored with Ann L. Szatmary
• "Microenvironments in the Pharmaceutical Industry" presented at CleanRooms East '94, Philadelphia, PA, March 1994
• "Environmental Management" course leader at the International Society of Pharmaceutical Engineers Annual Meeting, Panama City, FL, November 1993
• "Potent Compound Management" course leader at International Society of Pharmaceutical Engineers Philadelphia Seminars, Philadelphia, PA, September 1993
• "Is A Small Solution the Cure-All to Pharmacy Contamination" article CleanRooms Magazine, Volume 7 Number 8
• "Development and Management of Containment Technology" presented at Bitcon '93 Conference, Minneapolis, MN, August 1993
• "Potent Compounds - A Challenge for the '90s" article ISPEAK (newsletter for International Society of Pharmaceutical Engineers), June 1993
• "Barrier Technology with Relation to Potent Compounds" presented at The Institute of Environmental Science Annual Meeting, Las Vegas, NV, May 1993
• "Development of a Center of Competence for Containment Technology" presented at CleanRooms East '93, Boston, MA, March 1993
• "Bulk Pharmaceutical Operations - A Case for Change" presented at the International Society of Pharmaceutical Engineers Seminar on Containment Technology in Primary and Secondary Pharmaceutical Manufacturing, Amsterdam, Netherlands, March 1993
• "Containment of Potent Compounds" course leader International Society of Pharmaceutical Engineers Tampa Seminars, Tampa, FL December 1992
• "Containment - A Different Focus for Bio-Tech" presented at BioPharm Conference 1992, San Francisco, CA, June 1992.
• "Potent Compound Workshop" symposium for Pharmaceutical Manufacturers Association, Bulk Pharmaceutical Committee Spring Technical Symposium, San Juan, Puerto Rico, April 1992
• "Potent Compounds Are Cominq - Are You Ready?" presented at CleanRooms East '92, Atlantic City, NJ, April 1992
• "Containment Technology Supports and Reinforces Good Manufacturing Practices" presented at International Society of Pharmaceutical Engineers FDA Conference, Washington, DC, March 1992

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