Industries: Pharma / BiotechMedical Device

Heating, Ventilation, and Air Conditioning (HVAC) in a Regulated Environment

Course Director: Richard Newmiller

Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3

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.

Course Agenda

First Day

Introductions & Agenda Review 9:00am – 9:30am

Major Components of HVAC Systems 9:30am – 10:30am

  • Cooling, heating, humidification, and filtration
  • Air delivery and balancing
  • Dynamic and static controls
  • Exercise

Governing Regulatory Agencies 10:45am – 12:30pm

  • FDA regulations and guidelines
  • EU community of practice directives
  • ACGIH, ASHRAE, ASTM, ICH, CDC, NIH, SMACNA, WHO, and others
  • Exercise

Lunch 12:30pm – 1:30pm

Good Engineering Practice 1:30pm – 2:30pm

  • Policy statement, core concepts, project engineering, and management
  • Common practices, operations, and maintenance
  • Design conditions – 0.4% to 5.0% frequency factors
  • Energy conservation measures

Project Management 2:30pm – 3:30pm

  • Scope of work defined
  • Engineering and design – drawing and specification revisions
  • Contractor shop drawings
  • Change management – field conditions, end user modifications
  • Exercise

Psychrometric Overview 3:45pm – 4:30pm

  • Dry bulb, wet bulb, and grains of moisture
  • Latent and sensible loads
  • Heat transfer – people, equipment, and the building envelope
  • Exercise

Recap, Questions and Answers 4:30pm - 5:00pm

Second Day

Air Filtration 9:00am – 10:30am

  • Pretreatment, intermediate, and HEPA (mid-stream and terminal) filters
  • Filtration arrangements and system leakage
  • Sources of air particle contamination
  • Exercise

ISO Standards and Others 10:45am – 11:30am

  • FDA and EU classified space comparisons
  • In-use and at rest conditions
  • Room recovery period
  • Ventilation requirements
  • Exercise

Types of Systems 11:30am – 12:30pm

  • Supply air conditioning options
  • Recirculating air systems
  • Low humidity demands
  • Exhaust air – contaminate elimination/diffusion
  • Exercise

Lunch 12:30pm – 1:30pm

Air Balancing 1:30pm – 2:45pm

  • Site conditions during execution
  • Cascading air flows and room pressurizations
  • More art than science
  • The final report evaluation is critical
  • Exercise

Commissioning and Validation 2:45pm – 3:30pm

  • Documented plan with controls - observations, exceptions, and variances
  • The importance of as-built documentation - ETOP
  • Is the initial start-up commissioning?
  • FAT versus SAT - highly compressed schedules
  • Exercise

Safety Consideration 3:45pm – 4:30pm

  • Protection of people, product, and environment
  • System redundancy
  • Egress in emergency situations
  • Exercise

Recap, Questions and Answers 4:30pm – 5:00pm

Third Day

Risk Assessment 9:00am – 9:30am

  • Team approach with SMEs
  • Identification, probability, and impact
  • Detectability and reduction options
  • Exercise

Monitoring System Performance 9:30am – 10:30am

  • Control set points – range and tolerances
  • Alarms – alert, action, failure
  • Temperature, humidity, air flow, pressurization, particle counts, CFUs
  • Exercise

Instrumentation Calibration 10:45pm - 12:30pm

  • Identification of critical, non-critical, and informational instruments
  • Program set up and impact to operations
  • Required actions for out-of-spec conditions

Lunch 12:30pm – 1:30pm

Maintenance Operations 1:30pm – 2:30pm

  • Preventative, predictive, and emergency maintenance
  • Impact to performance, reliability, and validation
  • Exercise

Obtaining Funds for Repairs, Replacement, or Upgrades 2:30pm – 3:30pm

  • Documenting the current conditions versus requirements
  • Solution options and funding proposal
  • Generics facility case study

Recap, Questions and Answers 3:45pm – 4:15pm

Course Evaluation 4:15pm – 4:30pm

Learning Objectives

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.

Testimonials

"The Course Director was extremely knowledgeable with HVAC in any and all aspects. Overall a great course and definitely learned a lot." Mike K., Manager Quality Assurance – Dr. Reddy's Labs
"First off, the course director was excellent! Extremely knowledgeable, conveyed topics clearly and concisely, and most of all had a great sense of humor. I really enjoyed attending." Mike A., Manufacturing Engineer, Sanovas
"Good presentation, engagement of group, clear delivery. Sufficient time for presentation of materials. Helped my understanding of HVAC." Lindani M., Internal Auditor – Mead Johnson Nutrition
"This course was exactly what I needed during the process of designing our facility. The Course Director is very knowledgeable and has a lot of experience, he was able to answer all of my questions." Andrew R., President, Cannahort Agricultures