Ready to Start a Post? We’ve Got You Covered!
Starting a new discussion is a great way to share ideas, ask questions, and connect with others in the Continuous Manufacturing Knowledge Center. To make it even easier, we’ve created this example post to guide you. Use it to help structure your thoughts, showcase what you’re working on, and invite input from the community.
No question is too small—this space is built for learning, sharing, and collaboration at every stage. You bring valuable insight, and we’re excited to hear what you have to say!
Example of a Model Discussion Post:
| Clarity: A concise, straightforward title or ask |
How do you maintain lot integrity in a continuous manufacturing process? |
| Relevance: Related to pharmaceutical continuous manufacturing |
As continuous manufacturing (CM) becomes more prevalent, the question of lot integrity will become more important. |
| Contextual: Provides necessary background, references or images |
The company where I work presently has been dealing with this question for at least as many years as I have been here and cannot seem to come to a consensus of an acceptable path forward. In previous lives at companies that had implemented CM, there was an "assumed" amount of carryover based on theoretical calculations of purge volume from transfer tank to filling head. This may not have been a full CM process in that bulk was still being manufactured by individual compounded batches. However, even in a truly full CM process, the addition of new raw materials constitutes a new lot. |
| Open: Invites input, perspective, experience and feedback from other members |
How does one identify this lot as distinct from the previous? And at what point does the new "batch" of materials constitute a new finished product lot at the filler/finished package? |
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