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How do you maintain lot integrity in a continuous manufacturing process?

Jeffrey Reynolds

As continuous manufacturing (CM) becomes more prevalent, the question of lot integrity will become more important.  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.  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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  • One of the important aspects of lot control is to ensure that you understand what lots of raw materials have been used to produce a specific assigned lot of product.

    If you change from one raw material stream to a new batch of raw material, this will take a specific period of time to purge the original starting material from the system. This time would be used to assign SM lots to product lots.

    As long as you can attribute lots of starting material used to assigned lots of product in any CM system, then you should be in a good place to justify your position to any regulator.

    Obviously the batch record will also contain all relevant critical to quality processing parameters, which should be assigned to an individual product lot.

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  • One of the important aspects of lot control is to ensure that you understand what lots of raw materials have been used to produce a specific assigned lot of product.

    If you change from one raw material stream to a new batch of raw material, this will take a specific period of time to purge the original starting material from the system. This time would be used to assign SM lots to product lots.

    As long as you can attribute lots of starting material used to assigned lots of product in any CM system, then you should be in a good place to justify your position to any regulator.

    Obviously the batch record will also contain all relevant critical to quality processing parameters, which should be assigned to an individual product lot.

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