CHAPTER 6 THE ENVIRONMENT IN WHICH PHARMACEUTICAL PRODUCTS ARE MANUFACTURED – PART 1
How can you manufacture safe and effective pharmaceuticals?
1. Fortress to protect quality
Three principles of GMP consist of (1) Minimize human error, (2) Prevent contamination and quality deterioration, (3) Design a system that guarantees higher quality. Preventing contamination is very important and this should be part on the function of HVAC.
The pharmaceutical manufacturing process is fraught with the danger of contamination. However, it is impossible to manufacture pharmaceuticals in a completely closed system or in an unmanned state. Therefore, HVAC facilities serve as a fortress to protect products during manufacturing.
2. Various causes of contamination
Contamination is caused by foreign substances that should not be included in the drug product. foreign substances can also be of biological origin, such as workers’ hair and skin, or bugs.
in addition, there is also Cross contamination, which is the mixing of other products or raw materials, is also a problem in manufacturing plants that handle more than 1 product.
3. Required capability of HVAC system
HVAC system refers to the entire system that controls temperature, humidity, air cleanliness, airflow, etc. to provide an appropriate environment for people and objects inside a building.
HVAC system is required to achieve comfortable for people & achieve appropriate “cleanliness,” “temperature,” and “humidity” to protect the quality of pharmaceutical products.
4. Cleanliness level for manufacturing pharmaceutical products
The cleanliness level of a clean room is specified based on the number of particles of a standard size in a certain volume.…
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