Airborne Particle Counting for Pharmaceutical Facilities: Update 2008, EU GMP Annex 1
Morgan Polen - VP of Applications Technology, Lighthouse Worldwide Solutions
On February 14th, 2008, The European Commission updated Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, Annex 1: Manufacture of Sterile Medicinal Products.
This update comes into operation on March 1st, 2009.
(With the provisions on capping of freeze – dried vials implemented by March 1st, 2010)
Cleanroom and Clean Air Device Classification:
The formal cleanroom testing for classification should be done per the EN ISO 14644-1 standard.
Another key point stated in this update is that classification should be clearly differentiated from the operational process of environmental monitoring.
The maximum permitted airborne particle concentration is given in table 1.
Table 1: Updated limits in particle counts per Grade.
|
Maximum permitted number of particles per m3 equal to or greater than the tabulated size |
At rest |
In operation |
Grade |
0.5μm |
5.0μm |
0.5μm |
5.0μm |
A |
3,520 |
20 |
3,520 |
20 |
B |
3,520 |
29 |
352,000 |
2,900 |
C |
352,000 |
2,900 |
3,520,000 |
29,000 |
D |
3,520,000 |
29,000 |
Not defined |
Not defined |
Comparison Annex 1, to ISO 14644-1
To note the Particle Classifications are NOT Exactly per ISO 14644-1, but the amount of difference is listed in Table 2 for Grades C and D (note areas in BOLD)
Table 2
For cleanroom certification testing of Grade A zones, a minimum sample volume of 1m3 should be taken per sample location.
It should be noted that this follows the sampling guidelines of EN ISO 14644-1. For Grade A, the airborne particle classification is *ISO 4.8 and is dictated by the limit for particles ≥5.0μm, which is 20 particles per cubic meter.
*(EN ISO 14644-1 allows intermediate classifications with the minimum increment of 0.1)
For Grade B (at rest) the airborne particle classification is ISO 5 for both particle sizes and in operation, the airborne particle classification is ISO 7 for both particle sizes.
For Grade C at rest, the airborne particle classification is ISO 7 and in operation the airborne particle classification is ISO 8.
For Grade D (at rest) the airborne particle classification is ISO 8 and it is not defined for in operation. Click here to download the article.
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