Control for Critical Environments: HVAC Design Concepts (T14)

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Training

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

Date	Location	Country	Instructor(s)
26-28 August 2013	Durham, North Carolina	USA	Norman Goldschmidt
9-11 September 2013	Burlingame, California	USA	Norman Goldschmidt
9-11 December 2013	Tampa, Florida	USA	Norman Goldschmidt

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.

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

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.

Last Update: 17 May 2013