Flocon Industries’ Clean-in-Place(CIP)/ Sterilize-in-Place(SIP) System is a bespoke solution designed to sanitise equipment/systems efficiently to maintain process integrity. Our Clean-in-Place (CIP) function delivers automated, consistent, and effective surface cleaning of process vessels, pipelines, filters, and associated equipment, whereas the Sterilize-in-Place(SIP) function provides controlled thermal sterilisation using pure steam to eliminate microbial contamination and maintain aseptic conditions. By integrating advanced automation, recipe management, electronic batch records, and data integrity features, Flocon’s CIP & SIP solutions significantly reduce manual intervention, minimize downtime, improve operational efficiency, and ensure consistent cleaning and sterilization performance. Our systems are designed to maintain product quality, support regulatory compliance, and enable efficient manufacturing operations across critical process applications. Our custom solutions are designed in compliance with cGMP, FDA, and 21 CFR Part 11 requirements, ensuring reliable, repeatable, and fully validated cleaning and sterilization of process equipment without the need for dismantling.
Designed and manufactured in accordance with cGMP and ASME BPE hygienic design principles.
Chemical dosing system with controlled detergent concentration.
Fully automated operation with PLC-based control and HMI touchscreen interface.
Multi-tank configuration available for detergent, purified water, WFI, and recovery systems.
Recipe-driven cleaning and sterilization cycles with configurable process parameters.
Steam sterilization with automatic temperature control and validated holding periods.
Automatic control of temperature, flow rate, pressure, conductivity, and cycle time.
Integrated instrumentation including temperature transmitters, pressure gauges/transmitters, flow meters, conductivity sensors, and level sensors.
Integrated CIP and SIP functionality for cleaning and steam sterilization of process equipment and piping.
Data logging, batch reporting, alarm history, and audit trail capabilities (optional 21 CFR Part 11 compliance).
Constructed using SS 316L for all product-contact parts with hygienic surface finish.
Compact skid-mounted construction for ease of installation and maintenance.
Sanitary piping with orbital welding and hygienic fittings to eliminate dead legs.
Validation documentation support including DQ, IQ, OQ, FAT, SAT, and material certificates (as required).
Designed for compatibility with pharmaceutical process vessels, reactors, mixers, storage tanks, transfer lines, and filling systems.
| For CIP Systems | |
|---|---|
| Critical Parameters | Range / Requirements |
| Water Quality | RO / PW / WFI |
| Conductivity | As Per Cleaning Requirement |
| Temperature | Ambient to 90°C |
| Detergent | Caustic or Specialized Detergents |
| pH | 11 – 13 for Detergent Cleaning |
| Pressure | 2 – 5 Bar |
| CIP Cycles | As per Client Requirements |
| For SIP Systems | |
|---|---|
| Critical Parameters | Range / Requirements |
| Steam Quality | Pure Steam |
| Conductivity | < 1.3 µS/cm |
| Temperature | 120°C – 130°C |
| Pressure | 1 – 3 Bar |
| SIP Cycles | As per Client Requirements |
| Steam Nature | Dry and Pyrogen-free |
| Auto Temp Control | Validated |
Supplies purified process water (Reverse Osmosis, Purified Water, or Water for Injection) as the base for cleaning/
Stores measured quantities of wash water and chemical formulations at regulated temperatures for the cleaning process.
Provides a consistent flow rate and hydraulic pressure to cleanse and scrub internal equipment/
Supplies cleaning formulations through sanitary piping and valves to sanitise specific equipment/
It is the target unit where the cleaning formulation is sprayed with pressure to wash and sanitise the interior walls and internal contact surfaces.
Executes automated cleaning sequence phases (pre-rinse, chemical wash, intermediate flush, and final high-purity rinse) to wash away any contaminant residue or cleaning formulation.
Denotes the pre-cleaned, airtight processing unit or system piping that requires thermal sanitisation from bio-contamination.
Configures valve settings, sets safety pressure seals and ensures ventilation of the system to exhaust air during thermal operations.
Blows dry, pyrogen-free saturated pure steam onto the target system's internal surfaces and piping to push out air and heat the equipment's internal surfaces.
Increases the system temperature to the set sanitising point (typically 120°C to 130°C), while also accounting for condensate drainage to eliminate cold spots.
Maintains the system-set sanitising temperature and saturated steam for a standard exposure time to ensure thorough microbial decontamination.
Securely reduces input temperature and introduces sterile air or nitrogen pressure to prevent vacuum implosion during condensation while maintaining sterile conditions.
Years of advisory, purification expertise and client trust for storage and distribution systems
Positive passing rate of US FDA, WHO, and EU GMP ( Annex 1) compiance audits
Complete DQ/IQ/OQ validation package along with supporting documentation followed by protocol execution support.
Designed to meet current USP/BP/EU pharmacopoeia standards and WHO / cGMP requirements.
Find answers to common questions about our industrial and manufacturing services, processes, and support. If you need more details, our team is always ready to help.
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CIP (Clean-in-Place) and SIP (Sterilize-in-Place) are complementary processes used in pharmaceutical manufacturing. CIP removes product residues, organic matter, and contaminants from equipment and piping without dismantling, typically using validated cycles of water, detergents, chemicals, temperature, and flow. SIP follows cleaning and uses saturated clean steam, typically around 121°C, to destroy viable microorganisms and achieve sterilization. CIP focuses on cleanliness, while SIP focuses on microbial sterility. CIP systems require control of flow, temperature, chemical concentration, and contact time; SIP requires validated temperature, pressure, steam quality, exposure time, and condensate removal. Both require documented validation and routine monitoring.
Key CIP system components are based on the specific process and cleaning cycle requirement, but mainly include the following:
A validated CIP/SIP system must demonstrate consistent cleaning and sterilization performance throughout its lifecycle:
In practice, CIP/SIP validation confirms temperature, time, flow, pressure, chemical concentration, coverage, microbial control, and residue removal against predefined acceptance criteria.
Selection depends on
The device should provide validated, repeatable coverage of all product-contact surfaces, including hard-to-reach areas.
CIP cleaning efficacy depends on four key parameters: Temperature, Action, Concentration, and Time. Higher temperature generally improves soil dissolution and chemical reaction, within material and product limits. Correct chemical concentration ensures effective removal of organic, inorganic, and microbial residues; excessive concentration may damage equipment. Adequate flow rate provides mechanical action, helping remove deposits from surfaces and piping. Sufficient contact time allows the cleaning chemistry to work effectively. These parameters are interdependent: if one is reduced, others may need adjustment. A validated CIP cycle establishes appropriate ranges and acceptance criteria to consistently achieve required cleaning performance.
Cleaning validation is documented evidence that a cleaning process consistently removes product residues, cleaning agents, microorganisms, and other contaminants to predefined, scientifically justified acceptance limits.
For a GMP audit, demonstrate CIP effectiveness through:
Share your equipment queries, raw water parameters or loop requirements. Our engineering team will review your requirements and get in touch within 48 hours to clarify your queries and provide you with our best purity solutions.
