Cleaning Validation and Heavy Metals

We are currently developing a CV protocol for a Gelatin Melting tank. We are going to use TOC and microbial recovery for show that our cleaning procedure works. However there is a difference of opinion regarding whether we should be testing for heavy metals etc. So far I have not come across any documentation that tests for heavy metals when you are using a 304 or 316 stainless steel manufacturing tank. Please adivse.

Dear RJM,

For a gelatin mixing tank, you are not allowed to use SS304 since it is a direct product contact equipment. No need to test heavy metals for SS316 equipment. Since this equipment can be used only for gelatin melting, no need to go for validation of the cleaning procedure. however, if you are using different colorants in your formulations, then you need to prove the absence of the colors after cleaning

VEERRAJU