Manufacturing area in pharmaceuticals must be contamination free and all personnel working in area should take care about the hygienic conditions to protect the product being manufactured.
The quality and safety of pharmaceutical products should be a key concern to any manufacturer in order to take care of clients consuming the product as well as maintaining their brand name in the market. Therefore to prevent microbial contamination in pharmaceutical products, there are some key measures or considerations that a manufacturer needs to take care of.
Manufacturers need to consider the building requirements such as windows which should be sealed properly to prevent microbial contamination or dust from being collected. The interior surfaces such as walls, floors or ceilings should not have cracks to prevent microbial contamination from getting in and also it allows cleaning to be easy and effective. The light points, as well as ventilation, should also be good to enable the cleaning of all areas well.
The sinks used in the production areas should be of stainless steel to prevent rusting that may contaminate the pharmaceutical product that is being manufactured. Utensils used and transfer lines in manufacturing should be made up of stainless steel only.
Another key consideration is facility design. This is done to ensure the flow of production is done effectively and run smoothly. For instance, to ensure the room is clean, air filtration and air change rates should be set. Also in the critical areas, the flow of air should be in one direction with sufficient velocity in order to prevent the particles from closing the area. The temperature, as well as humidity, should be regulated.
In case of any contaminants are being generated in the area, there should be an efficiently working HVAC system to remove and prevent the contaminants from spreading to other areas. Finally, ventilation dampers and other services should be positioned for maintenance purpose in a place away from the production area for easy access.
Personnel should also be considered in the prevention of microbial contamination in pharmaceuticals. Every person working in the production area should maintain high-level hygiene. Also, the people handling the production should be trained on the importance of hygiene and should wear protective clothing such as hair cover, overshoes, overgarments and beard cover which are appropriate during the operations to prevent contamination. They must avoid direct contact with the product or any part of the equipment that may have contact with the product. Finally, access to the area where production is taking place should be controlled and only trained people should be allowed.
Utilities used in the production of pharmaceuticals such as water and steam should be carefully selected. For instance, high quality purified water having controlled microbial load should be used for pharmaceutical manufacturing. Cleaning and rinsing of the equipment must be done by purified water.
For cleaning and disinfection, cleaning agents should be of suitable grade to minimize any health risks. The area should also be cleaned and disinfected regularly. The equipment for cleaning should not have direct contact with the pharmaceutical product. The cleaning practice should be validated to ensure that the cleaning process is effective to control microbial contamination.
Everyone working in pharmaceutical manufacturing should take care of preventing contamination. Visitors, as well as the personnel of other departments, should also be trained for working in the classified manufacturing area. The equipment carried out from the out site could be a source of microbial contamination, therefore, those should be cleaned and disinfected.
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