— Validation Support
Cleanroom Validation
A sterile process is only as reliable as the environment around it. 10AR provides independent cleanroom classification and qualification to ISO 14644, bridging facility design and GMP so your controlled environments are both compliant and genuinely in control.
ISO 14644 — Classification & Qualification
ISO 14644-1 classifies air cleanliness by particle concentration; 14644-2 defines the monitoring plan; 14644-3 covers the test methods. 10AR supports classification and IQ/OQ/PQ, airborne particle counting, airflow visualization (smoke studies), recovery testing, and containment-leak assessment — at rest and in operation.
Alignment with EU GMP Annex 1
ISO classes must be translated into GMP Grades A–D and the continuous-monitoring expectations of the revised Annex 1. 10AR maps classification to grade, defines at-rest versus in-operation states, and designs monitoring that meets the regulation’s intent.
Monitoring & Requalification
Ongoing environmental monitoring, requalification intervals, trending, and remediation — so classification is not a one-time certificate but a maintained state of control.
