Swab limit for cleaning validation
Q. How do you calculate the swab limit, once it has been extracted in solution?
A. In general the swab limit for cleaning validations calculations go as follows:
Cleaning General Compounding Pharmacy Residues
Q: What can you recommend for cleaning glassware used in a compounding pharmacy?
A: For cleaning related to general compounding pharmacy residues via a washer, we would look to the same low foaming detergents used in pharmaceutical CIP systems as laid out here:
Using Concentrated Detergent Directly
Q: For ease of use, we would like to use the concentrated detergent in our lab directly, then add water. Any issues with that?
A: For Alconox Inc. manufactured detergents intended for manual / clean out of place use, we recommend making prior dilutions for usage of the detergents with known concentrations. However, an alternative would be to add a small amount of detergent concentrate (powder or liquid)….
Detergent Residue Interaction with Ketones and Solvents?
Q: We currently use Alconox to clean glassware at our facility. Do you have any studies showing potential Alconox detergent residue interaction with organic ketones and/or other organic solvents?
The short answer is that Alconox detergent, like all Alconox Inc. detergent products, are designed to be completely free-rinsing. Therefore leaving no residues to speak of. However, incomplete rinsing can of course happen. So this verification is important.
Guidelines for Triple Rinsing
Q. is there any industry guidance on triple rinsing…any literature that you know of that this is the accepted standard for manual cleaning that you could provide me?
A. To our knowledge, there are no authoritative source documents to define how many times you should rinse glassware. The logic behind a triple rinse is that, in filling and emptying a vessel three times with water, each time you are diluting by 2 orders of magnitude. In theory . . .