HVAC Cleanroom Design Concepts for Pharmaceutical Compounding

The Unites States Pharmacopeia is actively revising the standards governing pharmaceutical compounding facilities and will be introducing a new standard focused on hazardous compounding (USP 800) in July 2018. The introduction of this new standard will be accompanied by revisions to the existing USP 797 and USP 795 standards.

Topics covered in this lecture and discussion-based course include, but are not limited to, the following:

• USP 800 (Hazardous) requirements
• Existing and proposed USP 797 (Sterile) requirements
• USP 795 (Non-Sterile) requirements
• Solutions to handling the humidity issues that are very common in these rooms
• Common design and maintenance issues

We will have an interactive discussion about these subjects which will allow attendees to discuss their specific challenges.

Registrants are encouraged to email any specific topics that they would like to see addressed to Tammy Mandell: tmandell@cerhb.ufl.edu.

INSTRUCTOR BIOGRAPHY:

David Bess is the owner and principal of Advanced Systems Engineering, Inc. in Clearwater, Florida, and is in charge of all aspects of engineering and administration. David has extensive experience in providing mechanical engineering services for multiple industry sectors: LEED projects, State and Local Governments, Healthcare, Pharmaceuticals/Industrial, and Commercial. With over 24 years of experience in the industry, David is an expert in all aspects of Mechanical engineering and has a passion for working with complex mechanical systems. David is currently licensed in 15 states throughout the US and is a member of ASHRAE, ISPE, BioFlorida, and ASPE.