3. INTRODUCTION :
1. Air maintenance system plays a major role in the quality of pharmaceutical product
manufacturing Companies.
2. The manufacturing environment or space is very critical to product quality and is premised /
dependent on the air handling system which controls the level of containment (
pressurization)and cleanliness.
3. Air maintenance system to satisfy GMP/regulatory requirements must be suitably designed,
installed, qualified/Validated, monitored and maintained by professionals.
4. The uncontrolled air handling can lead to product degradation, loss of product, and economic
issue-profit , product contamination/cross contamination.
4. OBJECTIVES:
WHYAIR HANDLING SYSTEM IN PHARMACEUTICALMANUFACTURING:
1. Needed to condition and provide the ideal GMP environment or air space cleanliness needed
for the various pharmaceutical processes and controls in manufacturing .
2. A critical factor of Quality Assurance for pharmaceutical products( Clean areas/space for
manufacturing).
3. Issue of personnel comfort, satisfaction and safety.
4. As a means of containment control ( airborne particulate)and prevent Contamination and cross
contamination.
5. Avoid product rejection.
5. APPLICATIONS:
Environment protection:
No dust discharge, no fumes discharge, no effluent discharge.
Product protection:
protect from contamination , cross contamination, prevent contamination by operatives, correct
conditions of humidity and temperature.
Personnel protection:
prevent contact with dust, prevent contact with fumes, good comfort condition.
The GMP environment is only possible with an Air Handling System.
6. WHAT IS AIR MAINTANANCE SYSTEM ?
i. Air maintenance system is regard as HVAC and refers to Systems which are mechanical
arrangements that treats outside air to produce cleaned (from dust and microbes) conditioned air (
temperature and humidity) which is circulated or re-circulated for use in controlled and critical
areas within the pharmaceutical manufacturing space OR
ii. Can be simply said to be a utility system used to provide air ventilation, heating, cooling and air
conditioning services to a building or a pharmaceutical space for drug manufacturing
The Acronym HVAC means: H= Heating, V= Ventilation; A= Air; C= Conditioning
7. HVAC COMPONENTS :
1. Ducting ( for delivery of controlled air)
2. Fan component
3. Vibration isolator (flex joint)
4. Heating and /or coiling coil
5. Filter compartment ( houses pre and post filters)
6. HEPA Filter
7. Mixed (re-circulated + outside ) air duct
8. Louvers ( Weather)
9. Damper ( fixed adjustment of volume of air)
10. Dehumidifiers
11. Flow rate controller
12. Humidity, Temperature, Pressure sensors, alarms and
audit log system
13. Dust extractors
8.
9. FUNCTIONS OF AIR HANDLING SYSTEM (HVAC)
1. Control airborne particulate , dust and micro-organisms through air filtration using HEPA
filters.
2. Maintains room pressures ( in areas that must remain cleaner that surrounding areas (+ve).
3. Reduces contamination by air flow from cleaner areas toward adjoining space through
doors, , ceiling openings ( reduces chances of contamination).
4. Maintains space moisture RH(by cooling to due point temperature and using desiccant
dehumidifiers)
Maintains space temperature ( can affect product directly or indirectly)
All to minimize and prevent contamination and cross contamination
WHAT CAN AIR HANDLING SYSTEM NOT DO
Cannot clean up contaminated surfaces, room or equipment.
Do not compensate for workers who do not follow procedures.
10. CLEAN AREA/ROOM CONSIDERATIONS
• All pharmaceutical facilities belong to one/ certain or other class of clean rooms.
• Facility classification are based on clean air supply that matches the requirement for manufacturing
process/product.
• Clean rooms classification differs for sterile and non sterile and can be classified as such:
i. Non sterile operations/controlled or non aseptic
ii. Sterile operation/critical areas/aseptic applications
Examples of clean room requirements for some product lines:
i. tablets class D (10,000)
ii. topical and oral liquids belong to class C(10,000)
iii. sterile preparations/injectable – class A or B(100)
CLEAN AREA CLASSIFICATION CONSIDERATIONS
• Clean Room Classification defined in the state of “as built”, “at rest ,” or “in-operation”
• Clean rooms are also Categorized by way of which supply air is distributed :
Generally two air configuration:
i. Unidirectional -UDAF (Laminar) LAF or RLAF) . This achieved by Vertical down displacement of room
air or by horizontal laminar flow) – defined air velocity
ii. Or Non –Unidirectional air flow
11. AIR FILTRATION AND CONTROL OF
CONTAMINANTS
• External Air contaminants are removed by filtration
• Internal contaminants are controlled by dilution and
flushing or by displacement air flow
• Airborne particulates and level of filtration are
considered critical in Air Handling system
• The filtered air entering a production room can be
derivable from
i. 100% fresh air/external air or
ii. a proportion re-circulated ( Mixed with external/fresh
air)
12. POSITIONING OF FILTERS
• The required cleanliness or purity of air can be achieved with effective cleaning of the external air or recirculated air
through correctly designed and installed filters to meet the specifications or requirements for intended activity or
manufacturing operation.
• Filter location can be in the AHU, terminal …………….????
• filters are of various types , specifications and classes
TYPES OF AIR FLTERS
1. Ultra Low Particulate Air filter( ULPA)
2. High Efficiency particulate air filter( HEPA)
3. Packed towers
4. Membrane filter cartridges
5. Hydrophobic filters
SPECIFICATIONS FOR FILTERS
Simple MERV (1-16), pre filters (10, 20, 50µ efficiency 80-90% , secondary filters(5µ: efficiency up to 99%), HEPA filters
(0.3µ: efficiency upto 99.99
CLASSES OF FILTERS
Coarse (Dp < 10µ , G1-G4, Fine ( 1.0µ <Dp <10µ : F5 –F9); HEPA( H10-H14) &ULPA(U15-U16) both of Dp < 1.0µ)
Filter efficiency testing should be linked to the standard test methods ( different test methods could give different
results for same filter)
13.
14. DOCUMENTATION REQUIREMENT FOR AIR HANDLING SYSTEM
Description of installation and functions
Specification of the requirements ( Engineering and MOC)
Operating procedures (SOP)
Instructions for performance control (switch on and off)
Maintenance instructions and Maintenance records
Training of personnel (program and records)
O& M manual (operation and maintenance manual)
Test and balance ( TAB) reports/ Commissioning
Engineering drawings ( mechanical drawings, architectural drawings)
Log records for monitoring and data
15. CONCLUSION
Air Handling System plays a critical role in the wheel of factors contributing to product
quality in pharmaceutical manufacturing by providing the specific set of room space
conditions needed to make quality product. It must be properly designed, installed ,
validated by professionals, , monitored and maintained as a part of continuous
validation/revalidation of the critical system.
16. REFERENCES:
NAFDAC GMP Guidelines for Pharmaceutical products 2016
HVAC Design for Pharmaceutical Products, A. Bhatia
WHO Technical Report Series No.937, 2006, Annex 2
GMP and Quality Assurance of TB products, Kuala Lumpur, by
Majia Hietav
HVAC ; Gamal Amer, Premier Compliance services limited
HVAC Basics; Vishal Katyar
