HVAC for Pharmaceutical Facilities

Milan, 6-8 October 2008

Intermediate Level
ISPE CEUs*: 2.0
Type: Classroom Training Course

Instructor: Gordon Farquharson, Bovis Lend Lease Pharmaceutical (UK)

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 utilised 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.

Classroom Objectives

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 utilised 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

Take Back to Your Job

Walk away with detailed descriptions on HVAC system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers, and filters
Overview of critical parameters for products and processes that can be affected by HVAC
Basic concepts of controlling these parameters using properly designed HVAC control systems

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 utilised in pharmaceutical operations; and engineering professionals and other consultants who work with the pharmaceutical industry
This Training Course is of particular interest to existing and future members of the ISPE HVAC Community of Practice (COP)

Important Course Notes

Attendees will be provided with updates to course materials if GMPs or technology related to meeting GMPs change within twelve months of attending the course (e-mail address required). Participants should be familiar with basic pharmaceutical product forms and GMPs.


Training Programme General Information Venue and Area Information Sponsorship Opportunities Registration Information Download Brochure Current as of 28 May	HVAC for Pharmaceutical Facilities Milan, 6-8 October 2008 Intermediate Level ISPE CEUs: 2.0 Type: Classroom Training Course Instructor:* Gordon Farquharson, Bovis Lend Lease Pharmaceutical (UK) 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 utilised 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. Classroom Objectives 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 utilised 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 Take Back to Your Job Walk away with detailed descriptions on HVAC system fundamentals, including a discussion of primary system components such as fans, coils, humidifiers, and filters Overview of critical parameters for products and processes that can be affected by HVAC Basic concepts of controlling these parameters using properly designed HVAC control systems 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 utilised in pharmaceutical operations; and engineering professionals and other consultants who work with the pharmaceutical industry This Training Course is of particular interest to existing and future members of the ISPE HVAC Community of Practice (COP) Important Course Notes Attendees will be provided with updates to course materials if GMPs or technology related to meeting GMPs change within twelve months of attending the course (e-mail address required). Participants should be familiar with basic pharmaceutical product forms and GMPs.