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
Who Should Attend
This course is specifically designed for non-engineers such as Regulatory, Quality, Validation, R&D, Clinical, Manufacturing, Maintenance and Management personnel who are functioning as inspectors, auditors, investigators, operators, and end-users as well as those in project team or project management roles.
This three-day program will provide you with the training needed to enhance your understanding of HVAC systems in terms of design, construction, commissioning and maintenance to ensure compliance with Good Engineering Practice, International Standards Organization (ISO) criteria, Food and Drug Administration (FDA) Regulations and Guidance, European Union (EU) Directives, European Drug Regulating Authorities Lexicon (EudraLex) Guides, and International Conference on Harmonization (ICH) Guidelines.
Upon completion of this course, each participant will have a comprehensive overview and understanding of HVAC systems and how they are designed, installed, commissioned, and maintained in a regulated environment. The course content will enable the participant to understand the system design, ask more informed questions, and challenge the findings when communicating in a group setting on a broad variety of HVAC issues. In addition, the regulatory agencies with a direct impact on the design and operation of classified and non-classified environments will be presented.