Engineering Batch
A full-scale trial batch run to confirm the process on the receiving site's equipment before validation batches, usually not intended for commercial sale.
Why it is worth the cost
It surfaces the differences that documents hide: impeller geometry, jacket heat transfer, filter area per litre, lyophiliser shelf loading. Finding those in an engineering batch costs one batch; finding them in PPQ costs three.
Disposition
Engineering batches are held under quarantine, fully tested and used as supporting data. They are released for sale only where the regulatory position explicitly allows it.
Related terms
Where this applies
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