Ensure control of critical environments within your facility and maintain GMP inspection readiness through improvements to your air, HVAC, and contamination controls. Topics include control system alarm management, common system construction deficiencies, GMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
What You Will Learn
- Implement global GMPs for HVAC and Environmental Control
- Control and monitor HVAC system-critical parameters
- Utilize pharmaceutical cleanroom air classifications
- Improve product protection through efficient HVAC operation
- Select HVAC system designs appropriate for each production phase
Resources and Activities
- Pre-Course Work Materials
- Interactive Exercises
- Learning Assessments
- ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning
Online Live Course Modules
- GMPs for Environmental Control and HVAC
- Control of Contaminants and Cross-Contamination in Critical Environments
- The Design to Qualification Process (The Design Continuum)
- Cleanroom Design Considerations
- Cleanroom Design Techniques
- Applying Risk Management Tools to HVAC
- Typical Systems
- Documentation, Maintenance and Inspection
- Other References
- Final Exam, Exercises
Who Should Attend
- Project engineers, HVAC technicians and mechanics, HVAC control designers and commissioning personnel
- Government agency inspectors, quality assurance specialists, validation engineers, and manufacturing managers
- Professionals needing a thorough understanding of HVAC systems utilized in pharmaceutical operations
- Engineering professionals and other consultants who work with the pharmaceutical industry
Online Live Course Additional Details
This virtual course focuses on common issues and problems in the operation of a facility and maintaining readiness for GMP inspection. Topics include control system alarm management, common system construction deficiencies, GMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.
Participants will review global GMP regulations, including an update of ISO14644-1 & 2 reflecting 2015 changes, as well as common interpretations of those regulations and how they may apply to their facilities. The class will explore critical issues at each stage of the product lifecycle, from R&D to Manufacturing, such as: controlling cross-contamination between products, determining the correct classification of spaces, proper control of storage temperature and humidity, setting acceptance criteria for HVAC systems and using risk assessment to set environmental criteria. Workshops that include templates will be provided to help participants immediately apply what they have learned.
The course also examines the challenges and some accepted HVAC solutions for a variety of facility types, including Laboratories, Bulk Pharmaceutical Chemicals (BPC), Bulk Biologics, Vaccines, Oral Dosage Forms (solid and liquid), Sterile fill/finish, Medical Devices and Combination Devices.
Since HVAC systems can account for as much as two-thirds of the energy usage in pharmaceutical facilities, system design and critical parameter selection for efficiency will be explored for all facility types. Workshops are provided on the sustainability impact of choices made during design to provide participants with ready examples of efficiency evaluation to use in their own facilities. On completion of facility-specific systems, the requirements for verification or commissioning and qualification are explored with emphasis on distinguishing between critical and noncritical equipment and parameters.
Note: The course focuses on leveraging a solid understanding of the properties of air, HVAC and contamination control principles to assure control of critical environments.
Communities of Practice
This training course is of particular interest to existing and future members of the ISPE HVAC Community of Practice.