Blog Post

Why HVAC System in Pharmaceuticals Industry?

Heating, Ventilation and Air-Conditioning (HVAC) play an important role in ensuring the manufacture of quality pharmaceutical products. The most crucial parameter to consider is the Environmental Control. The Factors contributing to the quality of Products are Equipment Premises, Validated Processes, and Environment packing materials.
HVAC systems have an impact on product quality. It provides comfortable working conditions for operators. The impact on premises and prevention of contamination and cross-contamination to be considered at the design stage. Temperature, relative humidity control where appropriate Supplement to basic Good Manufacturing Practice (GMP)
The Manufacturing environment is critical for product quality, that depend on the

1. Lights
2. Temperature
3. Humidity
4. Air Movement
5. Microbial Contamination
6. Particulate Contamination
7. Uncontrolled Environment

Some environmental factors have a direct influence on a product:

1. Light, for light sensitive products (photo-degradation)
2. Temperature, for temperature sensitive products (many injectable, vaccines)
3. Humidity, often for capsules and always for effervescent tablets
4. Air movement, affecting contamination and cross-contamination
5. Microbial contamination can lead to the destruction of the product and to grave accidents in the case of injectable or sterile products
6. Particulate contamination is critical in injectable forms
7. What is Contamination?

Contamination is any product or substance other than the product manufactured, it may be foreign entities, particulate matter, microorganism, and endotoxins (degraded microorganisms).

• Products or substances other than the product manufactured (e.g. products resulting from air pollution)
• Foreign products, such as metal parts from equipment, paint chips, etc.
• Particulate matter, especially dangerous in injectable.
• Micro-organisms-a particular problem for sterile products.
• Endotoxins: Even if killed by thermal treatment, micro-organisms are degraded to endotoxins and can cause damage.

Cross Contaminations is a particular case of contamination. It originates from

1. Poorly designed or operated air handling system and dust extraction system
2. Inadequate procedure for personnel and equipment.
3. Insufficiently cleaned equipment.

Cross contamination can lead to sensitization or allergic reactions. In the case of highly potent drugs, it can lead to grave accidents.

There are different ways to prevent or reduce the effect of cross-contamination

1. Personnel procedures:Clean clothing, and for clean rooms (C, B, A) non-linting clothing, to be washed in special laundries; Personal hygiene on entering a pharmaceutical area.
2. Adequate premises:Minimisation of possibility of accumulation of dust; Premises with good ventilation and dedusting system.
3. Closed production systems:Closed systems, in which product is transferred from one piece of equipment to another one, without being exposed to the atmosphere.
4. Validated cleaning procedures:Manual cleaning procedures may not be reproducible.
5. Level of Protection concept 2:A good hygiene, or Level of Protection concept, specifying requirements for environmental conditions; entry procedures for personnel and material is fundamental for keeping cross-contamination under control.
6. Maintaining the correct air pressure differential between rooms helps prevent cross-contamination.
7. The module on HVAC deals precisely with the last of these ways, namely a good air handling system.

Control of contaminants

• External contaminants removed through effective filtration. Internal contaminants controlled through dilution and flushing, or displacement airflow. Airborne particulates and level of filtration considered critical
• Materials and products should be protected from contamination and cross-contamination during all stages of manufacture.
• Airborne contaminants should be controlled through effective ventilation.
• External contaminants should be removed by effective filtration of the supply air
• Internal contaminants should be controlled by dilution and flushing of contaminants in the room, or by displacement airflow.
• Airborne particulates and the degree of filtration should be considered critical parameters with reference to the level of product protection required.

Level of protection and air cleanliness determined according to:

• Product to be manufactured
• Process to be used
• Product susceptibility to degradation

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