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Cleanroom standards, measurements and classifications.

A wide range of different standards are used to specify the performance level that your clean facility should meet. Unfortunately it is not easy to compare one standard with another as they will often have different conditions applied to their methods of management, e.g. there will be differences between the number and position of samples to be taken, the pressure requirements between rooms, the relevance of certain size particles, the air change rates to be applied, etc.

The most common standards are US Fed 209E, BS 5295, EU GMP (Good Manufacturing Practice), or BS EN ISO 14644-1 (1999).

The tables below give an outline guide to the approximate comparisons between these standards but you cannot necessarily assume that meeting one standard also meets another. We are able to guide you further when you have a particular project to consider and design your installation to the appropriate cleanroom standard.


CONTROLLED ENVIRONMENTS TO BS 5295:1989
BS Class Maximum particle size/m3
(Equal or above stated size)
Max. area per sampling position (m2) Minimum pressure difference (+) (Pa) Approx. EU GMP equiv. at 0.5um size Approx. Fed Std 209E equiv. at 0.5um size Approx. ISO 14644-1 equivalent
  0.3μm 0.5μm 0.5μm 10μm 25μm   Between classified area & unclassified area Between classified area & adjacent area of lower classification      
C 100 35 <1 NS NS 10 15 10   1 3
D 1000 350 <1 NS NS 10 15 10   10 4
E 10000 3500 <1 NS NS 10 15 10 A 100 5
F NS 3500 <1 NS NS 25 15 10 B 100 5
G 100000 35000 200 <1 NS 25 15 10   1000 6
H NS 35000 200 <1 NS 25 15 10   1000 6
J NS 350000 2000 450 <1 25 15 10 C 10000 7
K NS 3500 K 20000 4500 500 50 15 10 D 100000 8
L NS NS 200000 45000 5000 50 10 10     9
M NS NS NS 450000 50000 50 10 NA      


CONTROLLED ENVIRONMENTS TO U.S. FEDERAL STANDARD 209E
FS Classification Maximum particle size/3 (Equal or above stated size) Approx. BS 5295:1989 equivalent Approx. EU GMP equivalent grade English
Sl English 0.1μm 0.2μm 0.3μm 0.5μm 5.0μm      
M 1.5 1 1240 265 106 35.3 NA C   3
M 2.5 10 12400 2650 1060 353 NA D   4
M 3.5 100 NA 26500 10600 3530 NA F(E) B(A) 5
M 4.5 1000 NA NA NA 35300 247 H(G)   6
M 5.5 10000 NA NA NA 353000 2470 J C 7
M 6.5 100000 NA NA NA 353000 24700 K D 8
MANUFACTURE OF STERILE PRODUCTS
ANNEXE 1 TO THE EU GUIDE TO GOOD MANUFACTURING PRACTICE (EC) 1997
EU GMP Classification At rest In operation Approx. Fed Std 209E equivalent Approx. BS 5295:1989 equivalent Approx. ISO 14644-1 equivalent
  Maximum permitted number of particles/m3
(equal to or above stated size)
Sl English    
  0.5μm 5.0μm 0.5μm 5.0μm        
A 3500 0 3500 0 M 3.5 100 F(E) 5
B 3500 0 350000 2000 M 3.5 100 F(E) 5
C 350000 2000 3500000 20000 M 5.5 10000 J 7
D 3500000 20000 NS NS M 6.5 100000 K 8


CONTROLLED ENVIRONMENTS TO BS EN ISO 14644-1 (1999)
ISO Class Max. No. of particle/m3 (Equal or above stated size)           Approx. equivalent BS 5295 Approx. equivalent FS 209E Approx. equivalent EU GMP
  0.1μm 0.2μm 0.3μm 0.5μm 1.0μm 5.0μm      
1 10 2              
2 100 24 10 4          
3 1000 237 102 35 8   C 1 M1 5  
4 10000 2370 1020 352 83   D 10 M2 5  
5 10000 23700 10200 3520 832 29 E/F 100 M3 5 A/B
6 1000000 237000 102000 35200 8320 293 G/H 1000 M4 5  
7       352000 83200 29300 J 10000 M5 5 C
8       3520000 832000 293000 K 100000 M6 5 D
9       35200000 8320000 2930000 L    




 
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  Clean Room Installation Services Ltd
9 The Metro Centre, Ronsons Way, St. Albans, Hertfordshire, AL4 9QT
Freephone: 0800 0186665      Tel: 01727 840594      Email: cleanrooms@stodec.co.uk


Clean Room Installation Services Limited specialise in Clean Room Construction, Cleanroom Installation, Clean Room Building, Cleanroom Design, Clean air enclosures, environmentally controlled enclosures, particle free atmospheres, temperature controlled environments, humidity controlled environments, Clean air environments also Cold rooms, Filtered environments, Air conditioned rooms, Sterile environments, Sterile rooms, Filtered rooms, we design and install Clean Rooms to BS 5295 standards, Class 100 rooms, Class 1000 rooms, Class 10000 rooms, Class 100000 rooms, Class C Rooms, Class D rooms, Class E rooms, Class F rooms, Class G rooms, Class H rooms, Class J rooms, Class K rooms, Class L rooms, Class M rooms, Clean Rooms to ISO standards, Clean Rooms to US Federal Standard 209E, including hardwall, softwall, walls can be PVC, plastic faced, vinyled, aluminium, stainless steel and can be fire rated or non fire rated. Our Clean Room designs include floors, ceilings, electrics, lighting, plumbing, ducting, all associated plant, transfer hatches, step over benches, interlocks, workstations, laminar flow cabinets, ducting, refrigeration and filtration, for the Pharmaceutical, Medical, Medical Device Manufacture, Packaging, Precision Engineering, Biotechnology, Veterinary, Plastics Moulding, Chemical, Food Processing, Research, Optical, and Aerospace industries, also for Universities and Facilities management companies,  which demand clean, air filtered and particle free environments. Supply of cleanroom furniture, clean room products, clean room equipment, clean room storage, such as shelving, storage bins, cabinets, trolleys, shoe racks, filters, hepa filters, benches, fan filter units, cupboards, seating, dispensers, lockers, vacuum and extraction systems, are also available.