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Rapid Mixer Granulator (RMG) Pharma Machinery FABON Pharma
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Clean in Place (CIP) and Wash in Place (WIP)

Clean in Place (CIP) and Wash in Place (WIP)

₹280,000.00

Ensure the highest standards of hygiene and compliance with our advanced Clean-in-Place (CIP) and Wash-in-Place (WIP) systems, designed for pharmaceutical, biotech, and food processing environments. These automated cleaning solutions eliminate the need for manual disassembly, reducing downtime, operator exposure, and contamination risk.

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Clean-in-Place (CIP) and Wash-in-Place (WIP) systems are an essential part of hygiene maintenance and avoiding cross-contamination in pharmaceutical production. Both systems automatically clean interior surfaces of equipment, pipelines, vessels, and connected fittings without disassembly. Both systems, however, clean equipment; CIP generally refers to a completely automated system, while WIP might be partially manual.

Technical Specifications:

  • Construction Materials:

Tanks and Piping: Made of high-grade stainless steel (AISI 316) to provide corrosion resistance and sanitary standards compliance.

Valves and Fittings: Constructed to be resistant to cleaning agents and high temperatures, providing durability and reliability.

  • System Components:

Cleaning Solution Tanks: Usually jacketed for temperature control, with capacities of approximately 250 liters, having conical bottoms for total drainage.

Heating Elements: Electric heaters built into tanks to attain and sustain the required cleaning solution temperatures.

Dosing Pumps: Peristaltic, piston, or membrane pumps to ensure accurate dosing of cleaning chemicals.

Centrifugal Pumps: For circulation of cleaning solutions in the system, promoting turbulent flow and efficient cleaning.

Control Systems: Computerized controls with programmable logic controllers (PLCs) to control cleaning cycles, check parameters, and provide repeatability.

  • Operational Parameters:

Flow Rates and Velocities: Specially designed to produce turbulent flow, which is generally at a rate of 1.5 meters per second, for efficient removal of residues.

  • JBTC

Temperature Control: Cleaning solutions are brought to the best temperatures for improved cleaning efficiency.

Chemical Concentration: Accurate management of cleaning agent concentrations to eliminate residue effectively without harming equipment.

  • Applications:

Equipment Cleaning: Cleaners are automated to clean reactors, mixers, blenders, tanks, and piping systems to eliminate product residues and impurities.

Process Efficiency: Decreases downtime incurred by manual cleaning, thus raising overall production efficiency.

Safety and Compliance: Guarantees standardized and verified cleaning procedures, adhering to regulatory requirements and preventing cross-contamination risks.

Installation of CIP and WIP systems in pharma manufacturing not only improves product quality and safety but also maximizes operational efficiency by minimizing labor and equipment downtime.

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FAQs

What is the difference between CIP and WIP?
Clean-in-Place (CIP): A fully automated or semi-automated system that cleans internal surfaces of process equipment (e.g., tanks, pipes) without disassembly. Wash-in-Place (WIP): Typically a semi-automated or manual cleaning system that uses fixed spray devices but may require operator assistance or partial disassembly.
Where are CIP and WIP systems used in pharma manufacturing?
CIP: Bioreactors, fermenters, mixing vessels, chromatography columns, pipelines, and filling lines. WIP: Tablet coaters, fluid bed dryers, blenders, granulators, and isolators.
What are the key components of a CIP system?
CIP supply tank (for water, detergent, or acid/alkali solution) Recirculation pump Heating system (electric or steam) Control valves and flow meters Spray balls or rotating spray heads PLC/HMI control panel (often 21 CFR Part 11 compliant) Conductivity, temperature, and flow sensors
What are the typical cleaning steps in a CIP cycle?
Pre-rinse (with water to remove loose residues) Detergent wash (alkaline or acid solution) Intermediate rinse Final rinse with purified water (PW/WFI) Optional sanitization or sterilization Drying (via hot air or nitrogen purge)
What are the advantages of using CIP/WIP systems?
Reduces downtime between batches Enhances cleaning repeatability and traceability Minimizes manual cleaning and contamination risk Saves water and cleaning agents Supports compliance with GMP, FDA, and PIC/S guidelines
What utilities are required for a CIP/WIP system?
Water (PW/WFI) Steam (for heating or sterilization) Compressed air or nitrogen Drain connection Electricity (for pump and control panel)
How are CIP and WIP systems controlled?
Automated CIP systems: Use a PLC + HMI with recipe control, alarms, and data logging (often CFR Part 11 compliant) WIP systems: May be manually operated or semi-automated with local control panels
What materials are used for construction?
Wetted parts: SS 316L with internal mirror finish (Ra ≤ 0.5 µm) Piping and valves: Tri-clamp or orbital welded SS 316L Gaskets: FDA-approved EPDM, PTFE, or silicone Tanks: Jacketed or insulated as required
What validation is required for CIP/WIP systems?
DQ/IQ/OQ/PQ protocols Spray coverage testing (riboflavin test) Cleaning efficacy and residue analysis (e.g., TOC, swab testing) Cycle repeatability and data integrity checks
What types of cleaning agents are used?
Alkaline detergents (for organic residues like proteins) Acidic detergents (for mineral scale or inorganic deposits) Disinfectants or sanitizers (e.g., peracetic acid, H2O2) Must be validated and compatible with product and equipment
What are common issues with CIP/WIP systems?
Issue Cause Incomplete cleaning Poor spray coverage or low flow/pressure Residue remains Wrong detergent or insufficient cycle time Cross-contamination Lack of proper rinse validation System blockage Inadequate drain design or filter clogging
What standards must CIP/WIP systems meet?
cGMP (21 CFR Part 210/211) FDA 21 CFR Part 11 (electronic records) GAMP 5 ISPE Baseline Guide Vol 5 (Commissioning & Qualification) ASME BPE (for biopharma) EU Annex 15 (Cleaning Validation)

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