Any advice on the FDA's requirements for bioburden limits or their determination in non-sterile raw materials for parenteral manufacture?

Have seen the figure of 900 cfu's per gram as an upper limit --not sure if this is the USP number or whwere it came from or if it's essential to come up with an in-house number based on historical data.

Thanks,
jim achmoody

You are correct in your last suggestion - Bioburden levels are specific to particular products and processes.

Thanks for the reply
jim