Hello people! here, a bunch of doubts! i apologize in advance.
I am collecting all the information I can, to carry out a cleaning validation on a milling machine (Jet Mill). My goal is to perform the Worst Case Rating (WCR)
In it, 24 different APIs are processed.
So far I have Ld50 data but I find it very difficult to find the ADE or PDE.
Is there a database on this?
The first big question is, should I work with ADE?
Can I save the situation by going to other criteria like ld50?
For now I have all the LD50 and the solubilities of each API, and I grouped them as follows, giving them values:
According to solubility in water: soluble 1, slightly soluble 2, Insoluble 3.
Then, by type of cleaning, which includes similarity between APIs and their form of cleaning and also, for their solubility in different solvents, namely:
- Class I water soluble substances. - Class II methanol soluble substances. - Class III acetone soluble substances. - Class IV separate class for special substances with defined solubility.
Once this is resolved, I will start to add the values obtained from the production operators through questionnaires, to determine how difficult it is to clean each one of them and give them values
My idea is to perform a matrixing and according to results, determine how many cleaning procedures must we do, and which API will be the chosen for carry out validation and its MACO or limits requirements based on ADE (hope can i use ld50).
I would like to know if my approach is correct.
Another questions is, after performing such a lot of work and validation. every time the equipment is used (assuming that the validation has already been carried out successfully), is it necessary in the usual practice to carry out some analytical verification ?, or is it sufficient for the cleaning procedure alone?
As I see the panorama, and from the previous results, I think I will have to make at least 4 different validations.
Any suggestions will be very welcome.
Any doubts about what is raised do not hesitate to ask me!