The CIP/SIP Process Module enables automatic cleaning and sterilization of equipment and pipelines without disassembly. By precisely controlling cleaning agent concentration, temperature, flow rate, and sterilization media (pure steam/overheated water), it ensures compliance with GMP, FDA, and EHEDG hygiene standards, eliminating cross-contamination risks and guaranteeing batch-to-batch production safety.
● Multi-stage programs:
-Pre-rinse → alkaline wash → acid wash → final rinse (conductivity ≤5 μS/cm)
-Customizable sequence switching
● Critical parameter monitoring:
-Temperature accuracy: ±1°C (pharma)/±2°C (food)
-Turbulent flow (Reynolds number >4,000) for full coverage (dead-leg residue ≤0.1%)
-Concentration control: Online conductivity/acid-alkali meters + dosing pumps (±0.1% accuracy)
● Pure steam sterilization (SIP):
-Temperature-pressure-time validation (e.g., 121°C/30min, F0 ≥15) with cold spot monitoring (ΔT ≤1°C)
-Biological indicator testing (Geobacillus stearothermophilus), SAL ≤10⁻⁶
-Overheated water sterilization: 121–135°C cycles for steam-free food/beverage plants
● Smart dosing: Closed-loop control of NaOH (1–4%) and HNO3 (0.5–2%) concentrations
● Recycling: Reuse filtered solutions (pharma) or neutralize discharge (food), reducing costs by 30%
● 21 CFR Part 11-compliant electronic records
-Automated cleaning/sterilization reports with temperature curves, flow rates, and target time
● Audit trails
-Logs for parameter adjustments, operator privilege changes, and system alarms
-In-place cleaning of bioreactors, fermenters, and fluid preparation systems
-CIP cleaning of storage/mixing tanks, SIP sterilization of sterile filling line
-Reduces cleaning time by 40% (turbulent flow design), 100% sterilization pass rate
-≥99.5% spray coverage (3D nozzle scanning verified)
-Meets EU GMP Annex 15, FDA cleaning validation guidelines, and EHEDG certification
-Full IQ/OQ/PQ validation package with challenge test protocols
-Heat recovery (steam condensate reuse) cuts energy use by 25%
-≥70% cleaning agent reuse, 50% wastewater reduction
-Cleaning efficacy simulation
-Residue analysis method development (HPLC, microbial limits)
-Shared spare parts inventory for rapid replacement of spray balls/seals
-Compliance audit assistance
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