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核心組成部分

Validation & Testing Module

● Online TOC analyzer (pharmaceutical): Rinse water TOC ≤500 ppb

● ATP bioluminescence detection (food): Surface microbial residue <50 RLU

● Sampling ports: For third-party validation (e.g., swab tests)

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Overview

Online TOC Analyzer (Pharmaceutical Grade)

Utilizes UV-persulfate oxidation method for real-time monitoring of rinse water total organic carbon. Data automatically uploads to LIMS systems, compliant with FDA 21 CFR Part 11 and EU GMP Annex 11 requirements.


ATP Bioluminescence Detection (Food Grade)
Detection sensitivity ≤10 RLU (Relative Light Units), providing microbial residue feedback on equipment surfaces within 15 seconds. Supports QR code linking to cleaning records, meeting HACCP and ISO 22000 certification requirements.


Physical Testing Interface
Sanitary sampling valves for swab testing and particle counter access. Third-party validation reports (e.g., FDA audit trails) enable seamless ERP integration, ensuring data integrity and traceability.

 


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