[b]This is from ISPE website[/B]
C[COLOR="#000000"]IP/COP Validation Test Procedure
by Jon R. Voss
In the hopes that sharing a test procedure from our library of ValPro™ procedures will get others to do the same, I submit the following procedure for your use. Let us know what you think!
The objective of this test is to verify that the sprayballs/wands/bars associated with the system are capable of delivering cleaning solutions to all exposed product contact surface areas. Often spray ball coverage testing is performed as part of the final vessel factory acceptance test. Coverage testing may be performed on-site using the actual equipment that will be used to clean the vessel.
Note: Care must be taken when working around cleaning systems. Solutions containing chemicals at high concentrations and temperatures are used in the normal operation of the system. Good practice is to have the system operator available at all times while this testing is being performed.
- For vessels with sprayballs/wands/bars that have already been tested (for example as part of FAT), audit the test documentation and verify that the following information is available and has been recorded for each sprayball/wand/bar:1.1 Vessel Identification
1.2 Sprayball/Wand/Bar Identification
1.3 Date of Test
1.4 Test Method (Riboflavin, Salt, Other)
1.5 Feed Solution Pressure or Flow Rate
1.7 Conclusion (Pass/Fail)
- For vessels with sprayballs/wands/bars that have not had coverage testing performed, perform the following tests for each spray ball/wand/bar:
2.1 Prepare the vessel/equipment item to be tested per normal operational cleaning procedures.
2.2 Prepare a solution of dilute riboflavin in a spray bottle per approved procedures (0.2 gm/L).
2.3 Spray the product contact surfaces of the vessel/equipment item with the riboflavin solution being sure to coat all exposed areas - especially those that may be ‘masked’ by vessel appurtenances.2.4 Initiate a cleaning cycle using (if possible) the minimum pressures/flow rates to simulate worst case conditions.
2.5 At the completion of the cleaning cycle, inspect the vessel product contact surfaces using an ultraviolet light. Look for traces of fluorescence - indications that the spray ball coverage failed to contact the surface in that location.
2.6 Document the locations of any fluorescence observed.
- For vessels with sprayballs/wands/bars that have already been tested, the test reports indicate successful sprayball coverage and contain the following information:
Date of Test, Test Method (Riboflavin, Salt, Other)
Feed solution pressure or flow rate• Results• Conclusion (Pass/Fail)
2. For vessels with sprayballs/wands/bars that are tested directly as part of this test, there will be 100% coverage as indicated by the observance of no fluorescence.
Note: If fluorescence is observed and can not be corrected by modification of the spray ball or cleaning cycle, the system will most likely have to have a manual cleaning step performed in order to effectively clean the area that is not covered by the sprayball/wand/bar.
Acceptance Criteria Met?
Yes ____ No ____ Initials/Date:____ /____
If No, explain in comments:
Reviewed By:_______________________ Date: __________[/color]