Euro GTP Guidance - Euro GTPs

Maximum permitted number of particles per m 3 equal to or greater
than the tabulated size
At rest In operation
Grade 0.5 �m 5 �m 0.5 �m 5 �m
A 3520 20 3520 20
B 3520 29 352000 2900
C 352000 2900 3520000 29000
D 3520000 29000 Not defined* Not defined*
*When the limit of number of particles is not defined, each tissue establishment should do it
according to a risk assessment study.
6. The ‘at-rest’ state is the condition where the installation is installed and operating,
complete with processing equipment but with no operating personnel present. The ‘in
operation’ state is the condition where the installation is functioning in the defined operating
mode with the specified number of personnel working. 16
7. The ‘at rest’ requirements should be respected in all cases. The ‘in operation’
requirements are only applicable to sterile operations.
8. For classification purposes in Grade A zones, a minimum sample volume of 1m 3 should be
taken per sample location. For classification purposes EN/ISO 14644-1 17 methodology
defines both the minimum number of sample locations and the sample size based on the class
limit of the largest considered particle size and the method of evaluation of the data
collected.
9. Portable particle counters with a short length of sample tubing should be used for
classification purposes because of the relatively higher rate of precipitation of particles
≥5.0ìm in remote sampling systems with long lengths of tubing. Isokinetic sample heads
should be used in unidirectional airflow systems.
10. ‘In operation’ classification may be demonstrated during normal operations, simulated
operations or during media fills as worst-case simulation is required for this. EN ISO 14644-
2 provides information on testing to demonstrate continued compliance with the assigned
cleanliness classifications.
16 EU Good Manufacturing Practices Guidelines
17 Cleanrooms and associated controlled environments ‐‐ Part 1: Classification of air cleanliness
16