The latest Annex 1 has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring.
Understand new definitions and expectations around EU GMP annex 1 for:
-
Cleanroom Classification Definition per EU GMP Annex 1
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. -
Which particle sizes should be measured per EU GMP Annex 1?
A significant change in Annex 1 from ISO 14644 is that in Grades A and B (ISO 5), only airborne particulates ≥ 0.5 µm need to be monitored. This is because of the low concentration of macroparticles in these areas. Annex 1 adds that we should also consider counting particles ≥ 1 µm. The requirements for Cleanroom Grades C (ISO 7) and D (ISO 8) have not changed. Airborne particulates should be measured at both ≥ 0.5 µm and ≥ 5.0 µm.
-
How Does EU GMP Annex 1 now define Cleanroom Qualification?
Defined as “the overall process to assess the level of compliance of a classified cleanroom with its intended use “cleanroom qualifications include room classification. Qualification methodologies are identified in EU GMP Annex 1 and all verification must comply with the testing methodologies in ISO 14644-3:2019.
- Understand EU GMP Annex 1 Cleanroom Qualification Verification and Requalification
-
Cleanroom Monitoring v. and overlapping with cleanroom classification and qualification
The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The key location focus of monitoring is at the manufacturing processes. The only connection with Cleanroom Qualification is that, as a secondary purpose, we also provide evidence of the performance of a cleanroom from the process point-of-view.
-
Cleanroom Monitoring Verification….
Learn more….