Might someone suggest a formula to calculate the residual limit for microbial contamination in manufacturing equipment for non-steril production?
Up to now, we have applied the following formula:
R.L. (cfu/cm²) = W.S. x B.S. /* S
W.S. = purified water alert limit (70 cfu/mL) BS = batch size of next product S = contact surface area (cm²)
Do you mind that the formula is correct for the purpose? Might someone have advices to get mes over this item or some useful bibliographic reference?
Many thanks to all