A central Taiwan pharmaceutical manufacturer brought a new aseptic dose-form line online and needed an ISO 14644-1 Class 5 qualification report to satisfy PIC/S GMP audit requirements. SYE delivered end-to-end cleanroom qualification and HVAC commissioning from DQ through OQ.
The original HVAC design undershot the recommended air change rate for aseptic processing, causing recovery tests to fail. With adjacent legacy production lines pushing up background particle counts, adjustments had to be made without impacting ongoing production.
ISO 14644-1 at-rest/operational particle counts and ISO 14644-3 HEPA integrity (DOP/PAO) testing
TAB balancing of supply/return airflow, tuning room differential pressure to +15 Pa
Smoke visualization to verify laminar flow and identify dead zones
Targeted terminal-filter reinforcement and ACH increases for rooms failing recovery tests
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