Pharmaceutical-Grade CIP Systems
These systems effectively remove residues and contaminants without the need for disassembly.
Applicable Sectors
Product quality and end-user safety
Regulatory compliance (cGMP, FDA, EMA)
Operational efficiency and validated repeatability
Performance Advantages
Validated Cleaning Performance
Precision sizing, flow rates (1.8 – 2.2m/s), and pressure control ensure complete residue removal while maintaining efficient cycle times
Regulatory Ready
Meets global standards: FDA cGMP, 21 CFR Part 11, ASME BPE, UL, and CRN. Full validation documentation and audit support is available
Optimised Utility Use
Automated cycles reduce water, chemical, and energy consumption while maintaining cleaning integrity
Operational Uptime
Efficient turnaround times between production runs, with repeatable, programmable cleaning logic
Key Features
- Skid-mounted or modular design
- PLC-based automated control
- Recipe-driven cleaning cycles
- Integrated conductivity and temperature monitoring
- Hygienic instrumentation and process valves
Typical Cleaning Phases
Pre-Rinse
Ambient °C WFI/PW for 5 – 10 minutes or until clear
Caustic Wash 2-3%
2% NaOH at 70 – 80°C for a period of time depending on site requirements.
Inter-Rinse
WFI/PW to conductivity setpoint
Acid Rinse (optional)
1% H₃PO₄ at 50 – 70°C for 2 – 10 min
Final Rinse
WFI/PW to spec, conductivity-based
Drain & Dry
Time or pressure-based sequencing
Compliance & Validation
Compliance & Validation
- cGMP & FDA 21 CFR Part 211/Part 11
- EU Annex 1 Aseptic Manufacturing Requirements
- ASME BPE Hygienic Design Standards
- ISA-88 Batch Control Architecture
- Full IQ/OQ Documentation Support
- Biological and chemical residue verification (TOC, conductivity, swab/rinse recovery protocols)
