PQ for CIP & SIP units

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
1

how can i do PQ for CIP & SIP units ?

2

A PQ would verify your URS. Start with listing your URS/regulatory requirements and Validation Master Plan and then go from there.

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In essence:

  • Performance criteria as laid out in the URS;
  • Regulatory criteria as laid out in the URS;
  • Critical parameters (perhaps you have a preliminary assessment of risk etc.) and their specifications.

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Non-exhaustive Rambling

For the SIP system, in particular, you may have a certain number of thermocouples or RTDs that are calibrated and then you use them to generate a temperature profile of your system. You would use a trend or chart to confirm that the temperature satisfies your Fsub0 requirements etc. etc.

Place the probes on the entry point to each vessel, at key piping points and any piping terminus or patch panel etc. Placing probes at the exit point is also key. The low point flood of condensation from a SIP system can result in a cold spot and you need to find that. You would need to run say three times (etc.) at say 130^C (well in excess of the normal SIP temperature) to prove you have no cold spots.

Now you have proved that you are warm enough. The next step is to prove that nothing can survive. You would extend your analysis by using biological challenges etc. to confirm the CFU count is satisfactory. The placement of the challenge material is beyond this posting and I would leave that to a skilled process engineer.

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More Rambling

For the CIP system I would tend to go for more of a functional test in the PQ. You need to adequately challenge the cycle, drainage etc. Much of this would be in the OQ so you don’t need to repeat it.

You need to make sure you have an adequate study to prove you have engineered around dead legs, low velocity areas, slope, turbulence etc. to not have dead spots for cleaning. This would be expressed in the URS and it would have to be objectively quantified so you can measure it.

So once you have your challenge parameters you can do your three runs and you’re done.

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Get some ideas from your SIP and CIP skid supplier about all the things they normally see at their other customers.

Ranjan Acharya
New Zealand

3

Well Put acharyar.

For CIP, you could also play with wash coverage studies using a luminescent dye-tells you about deadspots, etc.

4

For Qualification and sterilzation cycle development and validation OF SIP, the almost same procedure is apply like autocave, mapping, distribution with and w/o BIs.

Regards,