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Limits for solvents in API

Dear all,

in my factory the solvents are used commonly in the process for load of washes or other stage, the difficulty is establish the limit when the equipment is dirty of solvents and will be used in other product, may i use the visually clean criterion for use again the equipment in production?

what is your recommendation?

thanks for your comments

Dear Oscar

Visually clean criteria is always discouraged `coz “clean is not clean”, u better go for cleaning validation of equipment for solvents, impureties and other primery and secondary degradents, u need to validate suitable cleaning procedure, if u r talking abt organic solvents then see USP 30 for residual organic solvents test that is recommended to be checked in final raw material.

Shahid Ali
QA Manager
Addis Pharmaceutical Factory SC, Ethiopia

Thanks Shahid,

I´m going to check your reference, for establish a quantitative limit because as you told me the visually criterion is not trusty.

however this criterion may be is the first for assurance the cleaning of equipment