Die to Die should be used to validate the CIP process

What Die should be used to validate the CIP process of Manufacturing tank.
is same die may be used to check the cracks in same tanks.

Awaiting for ur valuable reply…

A common test for complete CIP coverage that is performed in the industries where sanitation is critical, such as the Pharmaceutical industry, is the Riboflavin test. To perform the test, a solution of Riboflavin is mixed with water and sprayed on the surfaces to be checked. Clean water is pumped through the spray devices, simulating the flow and pressure conditions of a CIP cycle, for a set period of time (normally in several intervals or bursts). After the allowing the vessel to drain, the surfaces under investigation are checked with a blacklight. Any surfaces that are shadowed, or did not have sufficient flow or velocity to remove the riboflavin solution, will become visible and fluoresce under a black light source. This is a stringent test, often performed by the vessel manufacturer. To assure repeatable results, the test is performed twice.

[b]This is from ISPE website[/B]

C[COLOR="#000000"]IP/COP Validation Test Procedure

by Jon R. Voss
September 1999

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!

Coverage Test-CIP/COP

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.

  1. 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

1.6 Results

1.7 Conclusion (Pass/Fail)

  1. 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.

Acceptance Criteria:

  1. For vessels with sprayballs/wands/bars that have already been tested, the test reports indicate successful sprayball coverage and contain the following information:

Vessel Identification
Sprayball/Wand/Bar Identification
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]

Could you please ell me What is the Guideline for that ?

ISPE no?