Control for Critical Environments: HVAC Design Concepts (T14)

Level: Advanced
ISPE CEUs: 2.0
Type: Classroom Training Course
COP: HVAC

Description

This course provides insight into the theoretical basis and practical application of environmental control for Pharmaceutical, Biotechnology, Vaccine, Medical Device and Combination Device companies.

The course builds on a solid understanding of HVAC and contamination control principles to assure control of critical environments. Participants will review global cGMP regulations, 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 students 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.

The course also focuses on common issues and problems in the operation of a facility and maintaining readiness for cGMP inspection. These 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...

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.

Course Modules

• Principles of Filtration focusing on HEPA and ULPA with MERV filters
• Advance principles of Cleanroom Design
• Principles of Automation and HVAC Control - EMS/BMS
• Understand the global cGMP for HVAC Environmental Control – focus on PIC/S and USFDA with mention of WHO
• Cross Contamination Control
• Building Automation and Environmental Monitoring
• Cleanroom Performance Assurance
• Design of Critical Facilities: Cleanroom Design, System Configurations, Oral Solids, Sterile Products and Medical Devices
• Sustainability and System Design
• Qualification and Risk Assessment
• Maintenance
• cGMP Documentation 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
• 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).

Continuing Education Units 

ISPE will provide continuing education units (ISPE CEUs) for all North American seminars and courses, including educational programming at the ISPE Annual Meeting. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Delegates attending European seminars and courses will receive a Certificate of Attendance, as ISPE CEUs are currently not offered at European events. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be sent via email within four weeks of evaluation materials. One hour of education programming equals 0.1 ISPE CEU credits.