Im confused about the limit for cleaning validation, such as how to calculate the criteria of chemical residua/rinse water/microbiology.
Thank in advance.
I’m no expert in cleaning validation but my company use Ecolabs for all their cleaning validation queries.
There website is
Hope this helps
Thanks for you help, but I need some free information.
The Limit Determination (Chemical Residue) can be based on 3 criteria, (1) 10 ppm criteria: proposed by most of the regulatory agencies that the 10 ppm of previous product is allowed to go into the subsequently manufactured drug product. To set limit on that basis, all you need to do is just follow the formula: 10 X batch size of next product. (it will be smallest batch size if your facility is a multi product)
b Therapeutic Criteria:[/b] a science based approach based on therapeutic data of drug formulation. It is well suited for fromulation facility where therapeutic profile of the drug products are well known. The formula:
TD X BS X SF X Swab Area / LDD X SESA
where TD=Smallest Therapeutic Dose of Previous Product Active
BS=Batch SIze of Next product
SF= Safety Factor (for Oral formulation it is generally of 1/1000
swab Area= Area of Swabbing
LDD= Largest Daily dose of next product
SESA= Shared Equipment Surface Area (product contact)
if your facuility is multiproduct, then all worst case will be considered from all products.
b Toxicological Criterion:[/b] mainly applicable in API or Intermediate facility or where the therapeutic data of products are not available. This based on the LD50 value of each product. Hope it will not be required by you. if so plz reply me I’ll give it to you.