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Frequent Reprocessing of Bulk
Hello Guys,
I just started my work in this manufacturing plant and I have observed that the RnD Dept frequently reprocess bulk. Reasons includes: curdy appearance, low and high viscosity, gritty feel and undispersed raw materials.
Based on my observations the problem lies on the manufacturing process, like time and temp or the manner of mixing.
Almost all products (new and existing) undergoes reprocessing and based on my analysis its almost 30% of produced bulk undergoes reprocessing.
what do you think is the main problem? is it the formula or the process?
I have never encountered frequent reprocessing on my previous jobs.
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7 Replies
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And what are the products we are talking about here????
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emulsions like lotion and sunscreens.
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There must be SOP for every product and it must be ensured that it is employed while charging the batches. It is indeed very strange to hear such a high percentage of batch reprocessing, has anyone tried pilot scales to make sure if they get it right before scaling up.
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we have a mfg procedure, it the sop you are talking different?
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I suggest you check that a) the formulas can be reproduced consistently in the lab, and b) the manufacturing procedures are actually being followed on the plant; in my view, problem is most likely to lie in one or both of those areas
the best way to check b) would be to supervise the manufacture of a batch, in person, from start to finish
also, it seems a bit strange that R&D would get involved in this rather than quality; reminds me of a certain British manufacturer who made their entire QC department redundant ‘because batches were taking too long to pass’
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I think it depends on the company. Where I worked this would have been a Product Development issue & not an QC issue. QC only ran tests on incoming and outgoing raw materials and batches.
I agree with the advice to make multiple batches in the lab to determine whether it is a formulation issue or a manufacturing issue.
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thanks to you both @Perry and @ Bill Toge, when we say multiple ran, is 5 x 1kg lab batch trial enough?
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