HVAC for Pharmaceutical Facilities

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Training

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

Description

This course will provide a detailed description of HVAC system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers, and filters. Participants will receive an overview of critical parameters for products and processes that can be affected by HVAC, and explore the basic concepts of controlling these parameters using properly designed HVAC control systems. Participants will discuss what HVAC can and cannot do to maintain good manufacturing practices (GMPs) as they are addressed for facilities designed to manufacture bulk pharmaceutical chemicals (BPC), oral solid dosage (OSD) products, sterile products, and bulk biopharmaceuticals. HVAC systems for production laboratories and warehouse facilities utilized for the storage of product, raw materials, and components are also covered.

On completion of facility-specific systems, the requirements for commissioning and qualification are explored with emphasis on distinguishing between critical and noncritical parameters. Other course topics include HVAC controls, monitoring of critical parameters, and system construction. Dust collection systems and laboratory fume hoods are not covered, as these systems are addressed by other sources. The course concludes with suggestions for system maintenance.

Attendees will be provided with updates to course materials if GMPs or technology related to meeting GMPs change within 12 months of attending the course (e-mail address required).

Participants should be familiar with basic pharmaceutical product forms and GMPs.

Course Modules

• HVAC Basics
• Air Filters
• HVAC Controls
• Air Balance
• Cleanroom Basics
• LAB HVAC
• HVAC GMPs
• API HVAC
• Oral Solids
• Sterile Products & Medical Devices
• HVAC requirements for GMP
• Design to Qualify, Economics
• Qualification and Risk
• IQ - OQ - PQ
• Wrap Up
• Air Filter References
• GMP References
• Design References
• Qualification References
• Other References
• Final Exam, Exercises

Take Back to Your Job

• Define basic HVAC system concepts
• Discuss HVAC system-critical parameters that must be controlled and monitored
• Distinguish among pharmaceutical cleanroom air classifications and explain how they are applied
• Explain the role of HVAC in protecting products
• Examine typical 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 maintenance requirements

Attendance Suggested For

• Project engineers, HVAC technicians and mechanics, HVAC control designers, commissioning personnel, government agency inspectors, quality assurance specialists, 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.