Cleaning and sterilisation

CIP & SIP: design, construction, automation & validation

In today's pharmaceutical operations, Cleaning-in-Place (CIP) and Sterilization-in-place (SIP) play a key role in the avoidance of cross-contamination and guaranteeing the sterility of drug processing equipment. These systems can only be designed with great technical skill and knowhow of the process critical parameters.

Agidens CIP and SIP systems are designed to automate critical cleaning and sterilization processes in a controlled and documented way providing the following functionalities:
  • Leak testing
  • Pre and final rinses
  • Chemical washes
  • Blow down and air drying
  • Vacuum
  • Sterilization
  • Concentration and temperature/pressure controls
  • Sterility monitoring

Agidens Scope for Cleaning in Place and Sterilization in Place:

  • Concept study
  • BOD (Basis Of Design)
  • Detailed engineering
  • Risk Analysis
  • Mechanical and electrical construction
  • Automation (PLC & SCADA/HMI)
  • Commissioning & Qualification
  • CE Certification
  • Cleaning validation & Process validation

Why Agidens for CIP and SIP?

  • As a specialist in cleaning and sterilization of  pharmaceutical processes our engineers understand the criticalities in your cleaning and disinfections processes and the strict regulation (GMP guidelines and 21 CFR part 11) which apply.
  • The combination of our process knowhow, our automation skills and cGMP compliance expertise makes us unique as a supplier to the Life Sciences industry.
  • Agidens performs A-Z deliveries of CIP/SIP systems up to process validation of the complete installation.
  • Agidens has established a specific pharma methodology A’GAMP containing general documentation and testing procedures in compliance with ASTM E2500 ensuring a flexible and thorough verification of the assigned requirements.

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