The new granulation suite went live this month after three qualification batches and a full media fill of the adjoining compression area. Capacity for solid oral dosage forms rises by roughly forty per cent.
What changed
High-shear granulation and fluid bed drying now sit inside a single controlled corridor, which shortens material movement and reduces the number of open-product transfers. Environmental monitoring points were added at each transfer step.
What did not change
Release remains the responsibility of the quality unit, against the same documented specifications. No batch leaves the site without a completed review of the batch manufacturing record, in-process data and finished product testing.