Design of a Sterile Facility in Pharmaceuticals

Learn how to design the sterile facility in pharmaceuticals including walls, floors, ceilings, doors, drains and lightings. Ankur Choudhary | GMP | Quality Assurance | Sterile Be the first to comment!

Efficiency and the maintenance of the sterile area directly depend upon the design of the sterile facility. Good design can save the area maintenance cost and quality of the area.

Following things should be considered while constricting the clean rooms.Walls: Walls of facility should be constructed by smooth material, steel or epoxy coated materials may be used. All exposed area should be smooth to avoid the shedding of particles and the microorganisms.

Related: Personnel Monitoring in Sterile Area

Floors: Floors should not have pores, non-slippery, non-absorbing, resistant to disinfectants and should be cleaned easily. Generally 3.5 mm thick epoxy is used on floor in pharmaceuticals. Corners on the floor should be covered with coving to prevent the accumulation of dust. Floor should be hard enough to bear the heavy loads of equipments and machineries.

Ceiling: False ceiling helps to minimize the contamination by covering the utility pipelines, ducts and electrical wirings but false ceiling should not have any cracks or space that can cause contamination.

Doors: Doors should not have unclean able areas and should be easy to clean. Doors should be open to higher pressure area to protect the area from the entrance of the contamination. Sliding doors cannot be used because of having unclean able areas. Doors should have automatic self closing system.

Drains: There should not be any sink or drain in class A and class B areas because it may cause microbial contamination. If it is necessary to have a sink in class A and class B areas then it should be easily cleanable and should be drain outside the area.

Lightings: Adequate lighting should be there for proper working in the area. Light intensity should be between 600-1000 LUX. Color of light should give comfort to personnel for working. Light panels should be closed properly to prevent the contamination.