CIP / SIP SYSTEM


The excellent clean ability of the entire equipment is one of the most important requirements a Filter and/or a Dryer needs to operate in compliance with cGMP and FDA guidelines.

To clean the equipment between individual batches or at product change over, spray balls are provided in the Filter / Dryer vessel, in the dust Filter housing and in the discharge valve. These spray balls will provide complete coverage of internal surfaces when operated at the specified fluid flow rate and pressure.

Typical CIP on Dryer vessel
To verify complete coverage of the CIP system a (optional) Riboflavin test is performed during the FAT. This test entails spraying all internal vessel, dust Filter housing and discharge valve surfaces with an aqueous Riboflavin solution.

The CIP system is then operated with water at the specified flow rate and pressure.

 

  
To pass the test all Riboflavin must have washed off all internal surfaces. Any traces of Riboflavin residue are made highly visible using ultraviolet light.

Above is described the standard solution, but the number of spray balls and the eventual use of a ring or a spray lance depends on the machine characteristics.

Molecule of Riboflavin

Circuit preparation
Check must be undertaken to ensure that the spray devices are correctly installed and that all fittings, probes, etc.
 
are fixed in place. The equipment must be clean and free from residues and films, especially oils and grease.Prior to the application of the Riboflavin solution, rinse the machine with water and allow the equipment to dry completely. In case if a Pressofiltro, remove the filtering element.
Install a suitable circuit with centrifugal pump, water tank, piping, valves and instruments. The flow and the head of the centrifugal pump have to be suitable for the machine size. If possible insert a flow meter on the pump outlet.
 
Test results

 The visual absence of Riboflavin will constitute a test success; any visually detected Riboflavin will constitute a test failure. The results of the test are fully documented on a dedicated form.
 
Instruments

The necessary instruments are:
       Ultraviolet lamp
       Manometers
       Thermometers
       Flow meter
 
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