HVAC cGMP Regulations Training Course

This classroom course focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. Topics include control system alarm management, common system construction deficiencies, cGMP documentation, maintaining an "inspection ready" state, frequency of testing and balancing, airflow visualization, air change rate reduction and more.

Participants will review global cGMP 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.

Immediately apply the course learning objectives with the complimentary copy of the ISPE Good Practice Guide: Heating, Ventilation, and Air Conditioning.

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

Take Back to Your Job

• Develop and understand global cGMPs for HVAC and Environmental Control
• Discuss HVAC system-critical parameters that must be controlled and monitored
• Distinguish among pharmaceutical cleanroom air classifications and explain how they are applied
• Be able to explain the role of HVAC in protecting products
• Examine HVAC system designs utilized for bulk, oral solid dosage, sterile, biopharmaceutical, and packaging and warehousing operations
• Understand the basics of process laboratory HVAC
• Describe HEPA filter theory, application, monitoring, testing, and repair
• Cite HVAC documentation and maintenance requirements

Attendance Suggested For

• 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

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE HVAC Community of Practice (COP).