Quantum receives a substantial amount of work from pharmaceutical manufacturers who cannot find a solution for the myriad problems that arise before, during and after production.
Batch testing is an ongoing process for most companies and this prescription product was stuck in the testing cycle after some small process changes were initiated. No one had an answer, so Quantum was asked to help find a solution.
The tablets were inconsistent. Not in color, but in how they went into solution for the testing itself- causing variability in analytical results. Some would dissolve easily – and some would not. This was a rare instance for the company who began focusing on the coating and excipient as possible culprits.
The real culprit was hiding in plain sight. By careful review of the recent process changes, Quantum was able to discover that one of the actual tablet presses caused the product to be pressed at a pressure ever so slightly outside the normal range, leading to the variability.
This small discovery led to improvements in the production process that saved days, and possibly weeks of re-testing.