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HVAC Design For Pharmaceutical Facilities (GMP'S) - A PDH Online Course For Engineers, Architects and Surveyors

HVAC systems in pharmaceutical manufacturing facilities must meet strict quality standards established by the FDA and GMP regulations. These systems aim to control airborne particles, maintain proper room pressures and airflows between clean and dirty areas, and regulate temperature and humidity. The course discusses HVAC design considerations for pharmaceutical facilities, including air filtration requirements, maintaining positive pressure differentials between rooms, constructing cleanrooms with smooth cleanable surfaces, and documenting engineering decisions for auditing purposes. Proper HVAC design, installation, and maintenance are crucial for producing safe and effective pharmaceutical products.

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114 views4 pages

HVAC Design For Pharmaceutical Facilities (GMP'S) - A PDH Online Course For Engineers, Architects and Surveyors

HVAC systems in pharmaceutical manufacturing facilities must meet strict quality standards established by the FDA and GMP regulations. These systems aim to control airborne particles, maintain proper room pressures and airflows between clean and dirty areas, and regulate temperature and humidity. The course discusses HVAC design considerations for pharmaceutical facilities, including air filtration requirements, maintaining positive pressure differentials between rooms, constructing cleanrooms with smooth cleanable surfaces, and documenting engineering decisions for auditing purposes. Proper HVAC design, installation, and maintenance are crucial for producing safe and effective pharmaceutical products.

Uploaded by

خبراء التصنيع الدوائي-اليمن
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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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.

Learning Objective
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:

1. Control airborne particles, dust and micro.comanisms – using high


efficiency particulate air (HEPA) filters.
2. Maintain room pressure differential (delta P) – providing more air into the
“cleaner” space than is mechanically removed from that same space.
3. Maintain space moisture (Relative Humidity) – Humidity can affect the
efficacy and stability of drugs and is sometimes important to effectively
mould the tablets.
4. 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)


Please click on the above underlined hypertext to view, download or print the
document for your study. Because of the large file size, we recommend that
you first save the file to your computer by right clicking the mouse and
choosing "Save Target As ...", and then open the file in Adobe Acrobat Reader.
If you still experience any difficulty in downloading or opening this file, you may
need to close some applications or reboot your computer to free up some
memory.

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:

1. Air should be of a high microbial quality.


2. 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.
3. 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.
4. All sterile critical operations shall be in a laminar flow work station.
5. 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.
6. 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
7. 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.comanization 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.

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