Medicine | Pharmacy | Chemistry


Good Active Pharmaceutical Ingredient Manufacturing Practices

Posted November 1, 2016 by Matt in Uncategorized

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.

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