The HandiLaz® Mini II handheld particle counter offers a powerful and nimble solution for pre-certification steps, identifying potential contamination hotspots, and troubleshooting high particle areas.
Particle Measuring Systems has designed a particle monitoring process for powder filling that satisfies current regulatory standards and eliminates a particle counter purge cycle.
Part 2 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The definition for Cleanroom Qualification is “The overall process to assess the level of compliance of a classified cleanroom with its intended use.” That is, classification is a part of qualification. Qualification methodologies […]
Part 1 of 3 part blog on : Cleanroom Classification – Qualification – Monitoring Per EU GMP Annex 1, rev 12 draft The latest Annex 1 draft has some new definitions and guidance regarding Cleanroom Classification, Qualification, and Monitoring. Cleanroom Classification Annex 1 provides essentially the same cleanroom classification definition as ISO 14644-1: 2015 which […]