Catalog of CIP stations
The design and integration of a CIP/SIP Station is a critical factor in ensuring the sterility and safety of pharmaceutical and biotechnological production. These systems automate the cleaning and sterilization of process equipment—such as bioreactors, storage tanks, and transfer lines—without the need for disassembly.
At INEX, we engineer each station by analyzing specific operational variables:
- Process Cycle Characteristics: Custom programming for rinsing, washing, and sterilization phases based on product residue.
- Detergent Compatibility: Selection of materials resistant to specific chemical cleaning agents.
- Utility Availability: Integration with on-site utilities, including technical steam and high-purity clean steam.
- Safety Protocols: Explosion-proof (ATEX) configurations where hazardous materials or solvents are present.
Key Features and Material Standards
The equipment is manufactured to meet the most stringent cGMP requirements, ensuring repeatable and documented results for every sanitation cycle.
- Superior Surface Quality: All product-contact components are made of AISI 316L stainless steel with a mirror-polished finish and a roughness of < Ra 0.40 µm to prevent bacterial adhesion.
- Robust Construction: Non-contact parts are made of AISI 304 with a high-quality finish (< Ra 0.63 µm).
- High-Grade Sealing: Utilizes EPDM and PTFE gaskets for excellent thermal and chemical resistance.
- Advanced Automation: Control systems are fully compliant with USFDA 21 CFR Part 11, providing electronic records, audit trails, and secure user access.
- Documented Validation: Every cycle produces a verifiable report of the cleaning and sterilization results, essential for regulatory audits.
Technical Specifications and Compliance
| Feature | Specification |
|---|---|
| Standards | cGMP, USFDA 21 CFR Part 11, GAMP 5 |
| Contact Materials | Stainless Steel AISI 316L (Ra < 0.40 µm) |
| Non-Contact Materials | Stainless Steel AISI 304 (Ra < 0.63 µm) |
| Seals & Gaskets | EPDM, PTFE (FDA compliant) |
| Automation | PLC-based with SCADA/HMI integration |
| Documentation Package | FAT, SAT, IQ, OQ protocols |
| Heating Method | Integrated heat exchangers (Steam or Electric) |



