Heating, Ventilation, and Air Conditioning in a Regulated Environment

This is a three-day course designed to provide individuals with an in depth understanding of the design, balancing, commissioning, operation and maintenance of HVAC systems in a regulated environment. The course consists of lectures and imbedded exercises. Participants will also be placed in several real life situations such as completing a compliance review of floor plans and air flow diagrams, room pressurization schemes, ductwork design, and air balance reports; conducting emergency egress analysis during a system failure; HVAC risk assessment; and change control analysis including the impact of modifications requested by the end user.

The course is designed to provide the attendee with thorough knowledge of the following topics:

• The governing regulatory agencies with direct impact on HVAC systems
• FDA and EU classified space comparison
• What constitutes Good Engineering Practice
• The major components of an HVAC system
• A high level overview of Psychrometrics
• The engineering and design process
• Latent and sensible loads
• Types of systems – application and operation
• Energy conservation measures and their impact on system performance
• Ventilation requirements
• Control set points and alarms
• Air balancing – cascading air flows and room pressurization
• Risk assessment for HVAC
• Air filtration – from bird screens to terminal HEPA filters
• Sources of air particle contamination
• Room air-change rates – ISO standards
• Room recovery period versus air change rates
• Sterility versus containment
• Humidity and temperature set points – range of control and tolerances
• Instrument calibration – critical, non-critical, and informational
• Maintenance impacts to system performance, reliability, and validation
• Partnering with the system owner to obtain funding for major repairs, upgrades or wholesale replacement
• Personnel safety and egress considerations
• The importance of as-built documentation – user and field directed changes
• The engineering turnover package (ETOP) and commissioning

Richard F. Newmiller has over 20 years of Pharmaceutical Industry experience. Presently he is a Senior Engineering Consultant supplying project management services with a unique background that includes corporate, contractor, consultant and owner perspectives.

Rich has provided Engineering, consulting, operations, and maintenance expertise as an employee for a variety of manufacturing and research organizations including Merck, SmithKline Beckman (now Glaxo SmithKline), Centocor (now Johnson & Johnson) and Wyeth (now Pfizer) where he was Senior Director, Project Engineering, Global Engineering Services.

He has executed hundreds of Pharma projects with a value in excess of $2 billion. Responsibilities included obtaining funding, contractor selection, design, engineering, start-up, commissioning, validation and assisting with establishment and product licensing. Those projects produced products that ranged from topicals, liquids, and solid dosage to injectables supporting OTC, diagnostic, biological, and pharmaceutical operations in the US, Canada, Puerto Rico, England and Holland. Rich received his B.S. in Mechanical Engineering from Drexel University, and an MBA from Temple University; he earned his Professional Engineering (PE) license in Pennsylvania.