Reply To: Particle count requirement for Clean Rooms

Improved Response: EUGMP Annex 1 (as well as WHO) defines Clean Rooms into Grade A, Grade B, Grade C and Grade D and requirements of clean room grades for typical operations. Also defines particulate (non-viable) and microbial (viable) count requirements

Typical Operation          Grade      ISO Class (rest)  ISO Class (Operation)   Particle Count(>0.5u/m3)  Microbial Count (CFU/m3)   

Aseptic Filling                Grade A       ISO Class 5           ISO Class 5                           3,520 / 3,520                          <1  / < 1

Background                    Grade B       ISO Class 5           ISO Class 7                           3,520 / 352,000                     <1 / <10

Solution Prep                  Grade C       ISO Class 7          ISO Class 8                           352,000/3,520,000                <100 / <200

Staging etc                      Grade D       ISO 8                     Not defined                           3,520,0000                              <200

USFDA requirements are also similar