-
Product concentration, homogeneity and reproducibility
Hi,
We are looking at pilot scale to produce ointment with only 3 key substances.
What can we do to ensure product concentration, homogeneity and reproducibility? (within a batch and between batches)
Is it norm to just assume homogeneity if we use electric mixer & 3roll mill? Or we still need to get analytical tools (e.g. hegman gauge etc.) or send it to lab for expensive concentration and reproducibility tests?
What does the industry do out there? -
3 Replies
-
Typically, you set specifications that can help determine if your product meets your quality standards.
To ensure the product concentration you just need to make sure the right amount of the ingredients are put in the batch. Have a batch sheet that is filled out by a compounder listing exactly how much of the substance was added.
For homogeneity, you can use color checks, physical evaluation, microscopic evaluation. This is the job for a quality control group. You don’t really have to have each batch chemically analyzed.
Most companies set their own specifications and have an in-house QC group do the testing.
-
Thank you Perry
-
If you are using a 3-roll mill, you will need to invest in a Hegman Gauge or some other method (microscopy, usually) to determine the particle size of what you are grinding. Otherwise, how will you know that you are finished grinding, or that you have the gap set correctly?
If you do not know when you are finished, you run the risk of wasting time and money running the mill for longer than needed, among other problems.
Log in to reply.