Blog

Engineering & compliance journal.

Field notes from the Mediclue desk on cleanroom validation, sterilization protocols and controlled-environment design.

FEATURED · VALIDATION

Understanding ISO 14644 Cleanroom Validation Standards

A practitioner's breakdown of particulate classification, recovery testing, and continuous monitoring obligations under ISO 14644-1:2015.

Why ethylene oxide remains indispensable for heat-sensitive instrument loads, and how to design exhaust and aeration loops that meet WHO compliance.

Unidirectional vs. turbulent airflow strategies for OSD, sterile fill-finish, and biologics suites — engineered for EU GMP Annex 1 (2022) compliance.