Cleaning Validation: Set residue limits for CIP-100 and active
Cleaning Validation: Set residue limits for CIP-100 and active
(OP)
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
Also, how is do determine the limit for CIP-100 in this case? What's the current limit for CIP-100 in insdustry?
Thanks





RE: Cleaning Validation: Set residue limits for CIP-100 and active
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.
RE: Cleaning Validation: Set residue limits for CIP-100 and active
PS, CIP additive has recently been banned from use in the EU....... Check with Steris