Qualification of CIP systems

CIP or Clean-in-place systemCIP system provides reproducible cleaning results and reduces the risk of cross-contaminationQualification of CIP systems demonstrates the proper functioning of equipment.  

Qualification of CIP systems is documented evidence that a standard cleaning cycle will provide the level of cleanliness of equipment suitable for the safe manufacturing of the subsequent products.   

It is ensured by spray-balls (static, rotating, and vertically moving), allowing to clean all the interior surfaces of the equipment (including hard-to-reach areas) and a properly designed system of tubes and automatic controls. 

During validation hard to clean areas, which surfaces are colored with a specific indicator must be determined. The performance efficiency of spray balls is defined visually under visible and UV light. Critical parameters of the cleaning process are temperature, fluid pressure (flow rate) and cleaning time, as well as detergent concentration and the number of cleaning cycles. 

In the pharmaceutical and biotechnology industry, CIP processes precede sterilization processes. 

Qualification of CIP systemsstages: 

  • DQ - Design qualification; 

  • IQ Installation qualification; 

  • OQ Operation qualification; 

  • PQ Performance qualification. 

Qualification of CIP systems, key points: 

  • Reviewing User Requirements Specifications for the acquired equipment (new equipment); 

  • Assessing equipment for its compliance with GMP; 

  • Checking the compliance of equipment appearance and labeling; 

  • Checking the completeness and relevance of the documentation received from a supplier; 

  • Checking equipment configuration and its proper installation; 

  • Ensuring that materials used for equipment have valid certificates; 

  • Obtaining documented evidence that the equipment operates properly and emergency, interlock and alarm systems perform efficiently; 

  • Monitoring the efficiency of control systems; 

  • Conducting qualification of sterilization systems, cleaning systems, and washing systems; 

  • Checking reliability and reproducibility of critical process parameters of the CIP process; 

  • Checking equipment performance under worst-case conditions; 

  • Verifying performance characteristics of the equipment to be qualified; 

  • Performing specific tests according to GMP guidelines. 

Upon CIP system qualification, you will receive: 

Qualification protocol is a document describing qualification activities to be performed for testing as well as defining specific parameters to be assessed, acceptance criteria of each of these parameters, assessment criteria, methods of measurement and measuring instruments, including information about their precision, verification and calibration. 

Qualification report is a document in which the results of completed qualification activities, initial information about the qualification object, analysis of obtained data, proposals for conducting requalification, and conclusions are assembled. 

All documents provided comply with the requirements of national and international GMP, GDP, and GSP standards. 

Determination of the performance of CIP systems and critical parameters of the cleaning process.

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