Cleaning Validation: Set residue limits for CIP-100 and active 2

[CVchemist]

I am working for contract manufacturing site. Some residue limits had been set using batch sizes and lowest unit doses of current and next batches. However, we don't usually know what the next batch will be. What would be a suitable approach to set the limit for active residue? Any inputs would be appreciated.

Also, how is do determine the limit for CIP-100 in this case? What's the current limit for CIP-100 in insdustry?

Thanks

 

[sundrop139]

As background, I work at a bulk chemical manufacturer that sells bulk excipients. We make over 300 products, none of which are active or sterile. We set our product residue limit at 10 ppm (w/w) in the next batch. We are audited by small and large pharmaceutical companies and none have requested a lower limit.

Second, one of our cleaning systems uses a blend of CIP-100 and CIP-Additive. We have found that these cleaning agents are EASILY rinsed as long as all product residues have been removed. On the shop floor we have a validated shake test sensitive to 1 ppm detergent in a water rinsate sample. Our detergent residue limit is 10 ppm (w/w) in the next batch for each.

 

[daviedalton]

If you don;t know what the next batch will be, you should base your limit on a worst case. Generate a matrix of cleaning limits from product manufactured to the next product in equipment. Base your limits on the tightest spec. If some combinations result in extremly low limits, you should try to avoid these changeovers. Our limits are based on toxicological opinion and 1/1000 of the therapeutic dose.

PS, CIP additive has recently been banned from use in the EU....... Check with Steris