Print this page HVAC Design for Pharmaceutical Facilities (GMP’s)
A. Bhatia, B.E.
Course Outline
Manufacturers in businesses such as pharmaceuticals rely on the performance of clean rooms to ensure crucial product standards are achieved. HVAC systems in manufacturing portions of pharmaceutical facilities are closely supervised by the FDA and failure to comply with any of the quality requirements can put the owner at both regulatory and business risk. Therefore it is important that the pharmaceutical facilities are constructed under a rigorous and well-defined quality-control system.
This 4 -hour course provides an introduction to “Good Manufacturing Practices” with focus on the HVAC system design.
This course includes a multiple-choice quiz at the end, which is designed to enhance the understanding of the course materials.
At the conclusion of this course, the student will:
- Be aware of the critical design issues related to pharmaceutical facilities;
- Understand what GMP is and why it is important for safe guarding the end user;
- Learn the current codes, standards and regulations that govern the GMP’s;
- State the requirements for proper pharmaceutical facility design including area classification, air change requirements and pressurization gradient;
- Explain the importance of product, equipment, materials and people flow in the facility;
- Describe the cleanliness requirements for sterile and non-sterile operations;
- Learn the cleanroom air classifications as defined by US FDA and European Economic Community (EEC);
- Describe HEPA filter theory, application, monitoring, testing, and repair;
- Learn the importance of pressurization and air flow pattern;
- Understand the basic air-conditioning schemes including types of air-handling systems (constant volume v/s variable volume);
- Learn about the air distribution ductwork materials, and location requirements; and
- Understand the commissioning, testing, validation and documentation requirements.
Intended Audience
This course is aimed at mechanical engineers, process engineers, HVAC engineers, process/production personnel, operation and maintenance engineers, environmentalists, H & S professionals, safety engineers, industrial hygienists and others responsible for design, purchase or upkeep of pharmaceutical facilities.
Benefit to Attendees
Attendee of this course will learn the engineering requirements deemed necessary for safe design and operation of pharmaceutical facilities.
Course Introduction
Pharmaceutical manufacturing is generally conducted in environments that are cleaner and are carefully controlled at a required temperature, humidity and pressure. The HVAC system assumes a large part of the responsibility in maintaining these clean environments. The main objectives of HVAC systems include:
- Control airborne particles, dust and micro organisms – using high efficiency particulate air (HEPA) filters.
- Maintain room pressure differential (delta P) – providing more air into the “cleaner” space than is mechanically removed from that same space.
- Maintain space moisture (Relative Humidity) – Humidity can affect the efficacy and stability of drugs and is sometimes important to effectively mould the tablets.
- Maintain space temperature - Temperature can affect production directly or indirectly by fostering the growth of microbial contaminants on workers.
The course discusses the above criteria in detail.
Course Content
This course is in the following PDF document:
HVAC Design for Pharmaceutical Facilities (GMP’s)
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Course Summary
HVAC systems in manufacturing portions of facilities are closely supervised by the FDA and must meet other global current good manufacturing practices (cGMP’s). Per US GMP, Design and Construction Features Standard (211.42), sterile area cleanrooms have the following distinct characteristics:
- Air should be of a high microbial quality.
- Air handling system is provided with a central HEPA filter bank along with mandatory terminal filters in order to extend the life of terminal filters.
- The filtration regime is generally three stages with two stages of pre-filters, 10 micron (EU 4), 3 micron (EU 8) and one central final filter 0.3 micron (EU 12) along with terminal HEPA filter.
- All sterile critical operations shall be in a laminar flow work station.
- Critical areas should have a positive pressure differential relative to adjacent LESS clean areas: a positive pressure differential of 0.05 inch of water (12.5 Pa) is acceptable.
- Supply air outlets are provided flush at the ceiling level with perforated stainless steel grilles and terminal absolute filters. Return air grilles to be provided at the floor level with a return air riser for better scavenging
- Walls, floors, and ceilings for cGMP areas are to be constructed of smooth, cleanable surfaces, impervious to sanitizing solutions and resistant to chipping, flaking, and oxidizing.
Maintaining proper pressurization gradient between adjacent spaces is important to prevent infiltration and cross-contamination. Air filtration techniques and air conditioning components shall be constantly monitored and upgraded in order to improve the finished product and reduce energy consumption. Remember, overstating quality requirements and tolerances may result in unnecessary costs. Higher air flows and pressures require more HVAC capacity. Since most engineering decisions will have an impact on HVAC systems, it is important to recognize opportunities to seek the best engineering solutions.
Every action of design, installation, operation and maintenance of HVAC services in pharmaceutical facilities is auditable and must be documented.
Quiz
Once you finish studying the above course content, you need to take a quiz to obtain the PDH credits.
DISCLAIMER: The materials contained in the online course are not intended as a representation or warranty on the part of PDH Center or any other person/organization named herein. The materials are for general information only. They are not a substitute for competent professional advice. Application of this information to a specific project should be reviewed by a registered architect and/or professional engineer/surveyor. Anyone making use of the information set forth herein does so at their own risk and assumes any and all resulting liability arising therefrom.
