Pharmaceutical Applications

Pharmaceutical Cleanroom Design has various design guidelines and standards that need to be considered before finalising options like which cleanroom system to use and what other components are required.

pharmaceutical cleanroom system

MSS Pharmaceutical Application Cleanroom

The fundamental issue is the concentration of airborne particles in the cleanroom. Particles can be affected by every component that has contact with the cleanroom, from the mechanical and electrical components down to the type of paper that may be used and including everything in between: walls, floors, ceilings, how the structure integrates with other components, and so on.

The new ISO standard defines a cleanroom as:

«a room in which the concentration of airborne particles is controlled, and which is constructed and used in a manner to minimise the introduction, generation, and retention of particles inside the room, and in which other relevant parameters, e.g. temperature, humidity, and pressure, are controlled as necessary».

Cleanroom are classified using ISO standards (although older standards are frequently referenced and should be known). These standards are based on the maximum number of airborne particles greater than or equal to 0.5µm in diameter that may be present in a cubic metre of room air.

The cleanroom and controlled environment classification chart below details the ISO standard 14644-1 alongside the commonly referenced Federal Standard 209E.

Cleanroom Classification		Concentration (particles/metre³) > or = Size Shown
FS 209E	ISO 14644-1	0.1 µm	0.2 µm	0.3 µm	0.5 µm	1.0 µm	5.0 µm
N/A	1	10	2
N/A	2	100	24	10	4
1	3	1,000	237	102	35	8
10	4	10,000	2,370	1,020	352	83
100	5	100,000	23,700	10,200	3,520	832	29
1,000	6	1,000,000	237,000	102,000	35,200	8,320	293
10,000	7				352,000	83,200	2,930
100,000	8				3,520,000	832,000	29,300
N/A	9				35,200,000	8,320,000	293,000

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