2008 Summer Meeting
Complying with USP <797>: Hoods, Isolators, and Cleanrooms
Track: Hot Topic
Program Code:121-L03
Date: 10 June 2008
Time: Tuesday, June 10, 2008
Location:Ballroom 6C - Level 6MEETING PLANNING ASSOCIATE:
| Mr. Kastango received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences (1983) and a MBA from the University of Phoenix (2001). Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. Mr. Kastango is the founder and President of the consulting company, Clinical IQ, LLC based in Florham Park, New Jersey, started in 1999.
Mr. Kastango is a Fellow of the American Society of Health-System Pharmacists. Mr. Kastango has over 150 invited professional presentations on a variety of quality systems and pharmacy practice topics in the United States, Japan, China, Australia, New Zealand, Holland, Ireland and the Czech Republic. He is a member of the 2005-2010 USP Council of Experts, Sterile Compounding Committee. |
MODERATOR:
| Mr. Kastango received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences (1983) and a MBA from the University of Phoenix (2001). Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. Mr. Kastango is the founder and President of the consulting company, Clinical IQ, LLC based in Florham Park, New Jersey, started in 1999.
Mr. Kastango is a Fellow of the American Society of Health-System Pharmacists. Mr. Kastango has over 150 invited professional presentations on a variety of quality systems and pharmacy practice topics in the United States, Japan, China, Australia, New Zealand, Holland, Ireland and the Czech Republic. He is a member of the 2005-2010 USP Council of Experts, Sterile Compounding Committee. |
PRESENTER(S):
| Mr. Kastango received his Bachelor of Science in Pharmacy degree from the Massachusetts College of Pharmacy and Allied Health Sciences (1983) and a MBA from the University of Phoenix (2001). Since 1980, he has practiced pharmacy in a number of practice settings (including hospitals, community, and home care) in a number of different of roles, including the Corporate Vice President of Pharmacy Services for Coram Healthcare Corporation. Mr. Kastango is the founder and President of the consulting company, Clinical IQ, LLC based in Florham Park, New Jersey, started in 1999.
Mr. Kastango is a Fellow of the American Society of Health-System Pharmacists. Mr. Kastango has over 150 invited professional presentations on a variety of quality systems and pharmacy practice topics in the United States, Japan, China, Australia, New Zealand, Holland, Ireland and the Czech Republic. He is a member of the 2005-2010 USP Council of Experts, Sterile Compounding Committee. |
| Organization: President,
Controlled Environment Consulting
Presentation:
Mr. Wagner has been involved with certification and design of controlled environments since 1979. He is a recognized expert in the field of Quality Assurance for controlled environments as used in regulated industries. He serves on the NSF joint committee responsible for NSF standard 49 (Class II Biological Safety Cabinets), the Institute of Environmental Sciences and Technology working groups responsible for HEPA filters, laminar flow equipment, and cleanrooms, and the CETA working groups for the applications guides for certification of engineering controls used in sterile compounding.
Mr. Wagner serves on the 2005-2010 USP expert committee for sterile compounding. He has twice served as president of the Controlled Environment Testing association.
Mr. Wagner is the primary instructor for the Eagleson Institute’s “Advanced Certification” class as well as multiple cleanroom certification classes. |
| Mr. Kilgore is co-founder and President of The CPI Group. He brings to each challenge more than 30 years of experience focused exclusively in the design and construction of health care facilities. He has extensive experience as a healthcare architect, design specialist consultant, and as the owner’s representative. His primary responsibilities are for programming, feasibility studies, master planning, facility design, functional planning, equipment planning and project development. |
Description:
Standards and regulations give guidance for accomplishing a necessary task but still leave enough room flexibility to accommodate different operations. This presentation will share experiences from early attempts to design and build USP <797> compliant sterile compounding facilities.
Learning Objectives:
- Explain the meaning behind the facility requirements in USP Chapter <797>.
- Develop strategies for compliance based on both positive and negative experiences of past projects.
- Explain how to communicate effectively with the project architects and engineers.
Mr. Eric Kastango, MBA, RPh, President/CEO, Clinical IQ, LLC