The transition from development to series production is a decisive and crucial step for pharmaceutical manufacturers. During scale-up at a major pharmaceutical manufacturer, work stoppages were looming due to product sticking. An on-site visit by consultants from Fette Compacting produced a workable solution in just a few days.
New product development usually begins on a separate development machine. This was also the path taken, for example, by one pharmaceutical manufacturer who first developed a new tablet on Fette Compacting's 102i tablet press, which is designed especially for galenics under near-production conditions. It turned out that the product began sticking after around 5,000 tablets. The production run had to be interrupted periodically for cleaning with a cloth and alcohol. While this limitation was still acceptable within the scope of the development phase, in series production, it would have led to substantial delays and resulted in additional cost increases due to unnecessary product loss.
From 5,000 to 500,000 tablets
Given the targeted number of 500,000 tablets per batch on the 2090i production machine from Fette Compacting, this cycle would have meant around 100 cleaning stops. To solve the problem, the customer contacted the Performance Consulting Team at Fette Compacting. Kai Schaumburg, OEE and Application Consultant, visited the manufacturing plant and scrutinized the processes and machine settings. It quickly became apparent that there was no problem with the machine parameters, but the wide range of mechanical setting options offered by Fette Compacting's tablet presses had not been fully utilized. When the machine began warming up - a normal effect during production - after around 5,000 tablets, the product started to stick between the top edge of the die table and the Fill-O-Matic.
It was possible to solve the problem quickly by readjusting the Fill-O-Matic table assembly and the product scraper. The result: uninterrupted operation for the entire batch of 500,000 tablets and substantially less product loss. "When we are consulted early on, we can adjust many mechanical settings on the development machine. Then it is easier to transfer them to the production machine. Therein also lies one advantage of our tablet presses: their capacity to make the transition from development to production virtually seamless," says consultant Kai Schaumburg about the outcome of the project.
Proper interaction is crucial
The challenges that can arise during scale-up are diverse: tablet breakage, poor bonding, product loss or strong dust development. "We help solve problems at an early stage or, ideally, avoid them entirely in advance. This is a matter of optimizing the proper tools, the ideal alloy or the suitable type of machine for the tablet shape" according to Britta von Selchow, Head of Training & Consulting at Fette Compacting. To this end, for example, Fette Compacting offers test runs both at the customer's location as well as at the Customer Center in Schwarzenbek. This ensures that the correct machine parameters and settings are established for validation of the new tablet.