18 October 2016
In Ireland, a Heparin manufacturer had a process with so many variables that it was difficult to control the final product. To them it was so uncontrollable that the entire process would be complete and delivered before anyone noticed an issue with the product being shipped.
In fact, the very worst person that could have noticed, noticed… the customer.
Only 30% of the shipped product was re-workable by this point and this equated to lost costs of approximately £300,000 and days of staff time spent trying to fix a preventable problem.
The staff members working in the processing department bore the brunt of the responsibility and, to be honest, they received most of the blame for not having a tool in place to notice appearance and quality change at the many various stages of this complicated manufacturing process.
Luckily the USP and EP identified a method of detection and HunterLab, a vintage and old favourite colour measurement company, manufactured the perfect solution to the problem…