Both personnel working at the active pharmaceutical ingredient plants, and the products being
manufactured, and the materials used in the production must be highly protected. Protection involves;
Hiring highly qualified personnel and taking them through orientation training to increase their
Making sure that equipment and the production premises are effective and up to the set standards
Labeling all materials, and containers correctly
Having in place suitable transportation and storage facilities
Keeping well-updated records
Enforcement methods of protection
Manufacturers must install efficient air filters to help put contamination and cross contamination at bay.
Air filters installed are dependent on ambient and return air quality. There are different protection levels
for divergent filters. It is the active pharmaceutical ingredient manufacturer’s duty to exercise measures
that will help counter contamination through the unfiltered air.
Cross contamination happens when dust or components of one product get in touch with another. With
the correct pressure cascade and air movement procedures followed, this can be avoided. The correct
pressure cascades should be used when manufacturing products with a high potent rating. In general, it is
important to ensure the right pressure cascades are installed according to the product being manufactured.
Different active pharmaceutical ingredient products have got different pressure cascade specifications.
There is a need to put in place special attention to the structural aspect of buildings. Active
pharmaceutical ingredient factories must be able to house different pressure cascade designs.
Consideration must also be put on the general set up of the building so as to bring down ingression and
egression of air.
Since the manufacturing process of APIs can cause more harm than good if special procedures are not put
in place to protect it. Measures must be put in place to control the emission of dust and vapor into the