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   EUGGMP Recommended Microbiological Limits   EUGGMP Recommended Microbiological Limits

Microbiological monitoring is also required to demonstrate the microbiological cleanliness of the cleanroom during production. The recommended limits are given in table 7.

Recommended limits for microbial contamination

Grade
AirSample cfu/m3
Settle Plates
(diam. 90 mm)
cfu/4 hours (b)
Contact Plates
(diam. 55 mm),cfu/plate
Glove Print
5 fingerscfu/glove
A
< 1
< 1
< 1
< 1
B
10
5
5
5
C
100
50
25
-
D
200
100
50
-

Notes
(a)   These are average values.

(b) Individual settle plates may be exposed for less than 4 hours.

(c) Appropriate alert and action limits should be set for the results of particulate and microbiological monitoring. If these limits are exceeded, operating procedures should prescribe corrective action.

The air classification required for a cleanroom that contains an isolator depends on the design of the isolator, and its application. The room that it is in should be controlled, and for aseptic processing be at least grade D.

Blow/fill/seal equipment used for aseptic production, which is fitted with an effective grade A air shower, may be installed in at least a grade C environment, provided that grade A/B clothing is used. The environment should comply with the viable and non-viable limits 'at rest', and the viable limit only when in 'operation'. Blow/fill/seal equipment used for the production of products for terminal sterilisation should be installed in at least a grade D environment.