The DMF in CTD format consists of 7 sections. In this video we will talk about section 3.2.S.6, which is about the container closure system, that is, the packaging material which is used to store the API which was produced.
This is a very simple section of the DMF, but it's connected to the next and last DMF section which is very important, related to the API stability.
Here we will find out what is the primary packaging material, that is, the one in direct contact with the API, and also what is the secondary packaging material, which will be around the primary one to offer more protection.
For example, the primary packaging may be a transparent polythene bag, while the secondary packaging may be a black polythene bag inside a cardboard drum.
For each of these materials, a description and the quality control specification must be provided.
Since the primary packaging will be in direct contact with the API, it needs to be a certified food-grade material.
In case the API is a liquid, a discussion must be included about the possibility of impurities leaching from this packaging material to the API, which could impact its quality.
We say that the packaging material has an impact in the API stability because it may help the manufacturer avoid the API degradation, depending on the conditions to which it is vulnerable. Can the API be degraded by humidity? Or can exposure to light cause its degradation?
For a photosensitive API, a secondary packaging material made of aluminum may be considered, since it protects the API from light and can help prevent the formation of degradation impurities. This is what we call a functional secondary packaging - since it has the specific funcion of photoprotection.
And this is all for the container closure system section. Its big impact is on the next section, which will be the topic of our next video - section 3.2.S.7 - stability of the API.
Stay tuned!
Music: www.bensound.com