Criteria for cleaning between two bathes of same product in bulk drug

I would like to know the cleaning acceptance criteria for batch to batch cleaning (same product). I think , for batch to batch cleaning the criteria should be some wider than 10 ppm criteria which is followed at a time of product change over.

Agreed the 10 ppm criteria may not be required between batches of the same product. In fact, there are some companies that do not even test between batches of the same product, let alone test to the 10 ppm criteria. This is commonly referred to a “campaign” manufacturing and cleaning. If you do go to campaign operations, please know there is a limit to the number of lots you can make between cleaning/testing, and to the time between the first and last batch. So that there is a # of lots AND a time of lots limit, this is due to the potential contamination from 2 sources including (1) degredants and (2) microbial or bioburden contamination.

If the product can break down into something else if left on the equipment, then cleaning is required. This is ascertained using a risk assessment, as nearly everything breaks down. If the product is left on the equipment, and promotes microbial growth, then you might have to clean and test between batches. For biologics or proteins, I would really examine if campaign cleaning is possible/likely. But for liquids/creams/ointments on the other side of the risk spectrum, campaign cleaning is probably more feasible.

To continue the discussion regarding 10 ppm limit, I would have you look up a number of other discussions on this forum regarding carryover limit. Most posts have “MACO” or “MAC” in the title, or cleaning validation. I think reading those posts will help out. But I’d be happy to discuss more with you, if those posts don’t answer all your questions.

1 Like

The carryover criteria is now based on the toxicity of the API (acceptable daily exposure) NOT 10 ppm. And there is no acceptance criteria for the same molecule.

There are many articles available on cleaning validation but nothing is clear for batch to batch cleaning criteria for same product.

I need to comment about campaign cleaning that I will define number of bathes or time period based on campaign cleaning study but my question remain same as what criteria to be followed during campaign cleaning validation study as this is same product

We have separate cleaning procedure for after maintenance or preventive maintenance so there is no problem on equipment break down. This cleaning procedure take care about oil Greece other lubricant and foreign particle traces and removed up to 10ppm levels.

Boomer chemist; We are manufacturer of active pharmaceutical ingredients which are manufactured with chemical synthesis. Also the process having multiple stages. Each stage are identified as intermediate. Its analyse and used in next stage of intermediate or in API. Toxicity data or acceptable daily exposure not available for every intermediates stages so during product I do over we use 10ppm criteria for cleaning. But I am slightly confused for cleaning criteria while batch to batch cleaning for same product. I don’t have any reference gidence for cleaning criteria during same product cleaning.

The toxicity data (ADE) applies only to the API you ship since it is based on the consumer. But in order to control the carryover of the API you will also have to control the concentration of your intermediates. You can use a molecular weight ratio (MW).

You can obtain ADE data via

The latest cleaning validation reference is chapter 3 and 5 of the Eudralex. The EMA (Europe) does have a separate reference online on setting ‘health based’ cleaning validation (CV) limits. See;

There are no guidances for batch to batch cleaning of the same product. Your CV target is based on the ADE. I presume you are asking because you are thinking of developing a CV campaign. Remember, it is your cleaning procedures which are being evaluated and the yardstick is the molecule’s carryover (based on health based limits).