{ENGLISH} CHAPTER 6 THE ENVIRONMENT IN WHICH PHARMACEUTICAL PRODUCTS ARE MANUFACTURED – PART 2

CHAPTER 6 THE ENVIRONMENT IN WHICH PHARMACEUTICAL PRODUCTS ARE MANUFACTURED – PART 2

6. Establish appropriate cleanliness levels

Pharmaceutical products should be manufactured in an environment with an appropriate level of cleanliness depending on the nature of the process. For example, processes in which products are exposed to the environment, such as the filling process, can be conducted in a cleaner environment to reduce the risk of contamination by impurities.

Therefore, when constructing a pharmaceutical manufacturing plant, the entire plant should first be zoned in consideration of the manufacturing processes. To achieve a high level of cleanliness, it is also important to lay out the plant so that areas of high cleanliness are surrounded by areas of low cleanliness.

Figure-1 Clean class and gowning

Grade AA (Critical area), Grade A (ISO 5) and Grade B (ISO 7) are conventional laminar booth. Areas where sterilized products are exposed to the environment are prevented from contamination by Grade A cleanliness levels, and their surroundings are considered Grade B.

Class F is CNC which means Controlled and unclassified, usually applied to secondary packaging rooms and QC areas, while class G unclassified is usually applied to offices, warehouses, canteens, machine rooms, etc.

Grade AA, A & B is a conventional laminar booth, but EU GMP Annex-1 introduces Barrier technologies. The design of the RABS or isolator shall take into account all critical factors associated with these technologies, including the quality of the air inside and the surrounding area, the materials and component transfer, the decontamination, disinfection or sterilization processes and the risk factors associated with the manufacturing operations and materials, and the operations conducted within the critical zone.…