Good Active Pharmaceutical Ingredient Manufacturing Practices
Since active pharmaceutical ingredient manufacturing is a delicate procedure, it is important to make sure
all heating, ventilation, and air-conditioning or simply HVAC are properly designed to ensure a safe
working environment.
How to protect persons and the products
High standards of hygiene should be exercised in all areas and tools involved in the production of the
active pharmaceutical ingredient. Some of these include; the starting materials, equipment utensils, and
packaging materials.
In order to achieve this standard of cleanliness, stringent rules should be followed while designing the
production areas.
What to consider
When designing the particular consideration should cover the following areas;
Temperature regulation of the room
Room pressure
Materials to be used for finishes
How to handle material and personnel flow
The air regulation terminal placement
Movement of equipment when the need arises
Special consideration should be put in place to ensure that the correct air change and air filtration
equipment are installed. This ensures that cleanliness is maintained at all times. Under normal
circumstances, air change rate in an active pharmaceutical ingredient factory is determined by many
factors. Eg, the particulates which are bound to be produced during the manufacturing process,
characteristics of the product being manufactured. Whether it has an odor or not and many others.
Manufacturers should ensure that practices are put in place to avoid product to human contamination and
cross-contamination. During the active pharmaceutical ingredient manufacturing, contamination through
air circulation is quite common if the right measures are not put in place. To avoid this, the manufacturers
should make sure that the rooms are well fitted with filtration and ventilation equipment.
Effective air supply filtration practices help in preventing external contaminants, while internal
contaminants should be avoided and controlled through the dilution and displacement airflow procedures.
With all said the air cleanliness and safety depend on the products being produced.
