: Testing for temperature and relative humidity levels, which can impact both sensitive equipment and the comfort/performance of personnel. Industry Applications
: Providing different test methods to accommodate various cleanroom types, including unidirectional (laminar flow) and non-unidirectional flow designs. The Two Tiers of Testing iest-rp-cc006
: Verifies the integrity of HEPA and ULPA filters and their seals to ensure no contaminants bypass the filtration system. : Testing for temperature and relative humidity levels,
The document outlines who may perform tests (trained personnel only), how to document results (traceable logs), and what constitutes a failure requiring corrective action. The document outlines who may perform tests (trained
For sterile drug manufacturers using isolators for aseptic filling, CC006 provides the bridge between design qualification and routine re-certification—typically every 6–12 months depending on usage intensity.
The primary goal of IEST-RP-CC006 is to assist designers, manufacturers, and end-users in preparing detailed specifications for cleanroom procurement and performance verification. Key objectives include: