Classification, Qualification and Monitoring According to EU GMP Annex 1 Rev 12
The latest Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring.
Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015, which is a “method of assessing the level of cleanliness against a regulatory specification for a cleanroom or clean zone.”1 Annex 1 also defers to ISO 14644-1:2015 definitions for the various cleanroom standards and specifications. In Annex 1, Revision 12, nothing has changed regarding the association between pharmaceutical grades and the ISO classes:
- Grade A and B cleanrooms must comply with the ISO 5 requirements in at-rest occupancy state.
- Grade C cleanrooms must comply with ISO 7.
- Grade D cleanrooms must comply with ISO 8.
To classify a cleanroom, the total number of particles is measured for both at-rest and in-operation states. Annex 1 and ISO 14644 also align regarding classification. Annex 1 follows the ISO 14644 table with one adjustment: Grade A and B surrounding locations should consider all critical processing zones with a documented risk assessment. This is not the same Cleanroom Risk Assessment (RA) as a Cleanroom Monitoring RA, which is for studying processes. The purpose of the RA for cleanroom classification is to ensure that all critical zones with processes are covered.