113- ISO 14644-1: Classifi cation of air cleanliness
- ISO 14644-2: Specifi cations for testing and monitoring to prove continued com-
pliance with ISO 14644-1 - ISO 14644-3: Test methods
- ISO 14644-4: Design, construction, and start-up
- ISO 14644-5: Operation
- ISO 14644-6: Vocabulary
- ISO 14644-7: Separative devices (clean air hoods, glove boxes, isolators, and
mini-environments) - ISO 14644-8: Classifi cation of airborne molecular contamination
There are two classes of clean room suggested for cellular production: classes
1000 and 10,000. However, clean room class 10,000 is very expensive with high
initial investment and maintenance fees; therefore, most GMP facilities for cellular
production are clean room class 1000. Specifi cations of the two kinds of clean room
are listed in Table 6.3.
In addition to a clean room, GMP facility equipment for production procedures
should also be considered. Because of limited funds, it is necessary to prioritize the
specifi c needs of the facility. All equipment should be divided into three groups:
- Essential: tissue culture cannot be performed reliably without this equipment.
- Benefi cial: culture would be performed better, more effi ciently, quicker, or with
less labor. - Useful: items that would improve working conditions, reduce fatigue, enable
more sophisticated analyses to be made, or make the working environment more
attractive.
Based on the budget, required equipment should be prioritized when purchasing
instruments. However, there are three issues that should be considered before pur-
chasing equipment for GMP facilities:
Table 6.3 Specifi cations and test results of two classes of clean room facility based on ISO 14644
standards
Cleanroom classes specifi cationsISO class 6 (class 1000) ISO class 7 (class 10,000)
Standard limit Test result Standard limit Test result
Air change per hour ≥110 115 ≥50 60
Particle count
0.5 μm 35,200 12,849 352,000 169,969
5 μm 293 424 a 2930 1977
Temperature ( ̊C) 22 ± 3 21.5 22 ± 3 21
Noise (dB) ≤65 59 ≤65 60
Air pressure (Pa) ≥37.5 38 ≥12.5 15
Humidity (%) 30 ± 15 26 30 ± 15 22
Microbial count (CFU/m^3 ) <5 3 <50 22
a Non-compliance with the specifi ed ISO class. The tests were performed at-operation by clean-
room supplier
6 Production of Clinical-Grade Mesenchymal Stem Cells