The way forward for
Pharma 4.0, Brexit, FDA regulation and more: Major topics were on the ticket for the ISPE Europe Annual Conference. The growing trend toward containment was another topic providing intense discussion among the specialists in Dublin. Dr. Martin Schöler, Head of Engineering at Fette Compacting, showed how a novel measuring procedure enables cost-effective containment.
The use of highly active ingredients in pharmaceutical production has been growing for years. Manufacturing plant must satisfy ever-tightening requirements for the protection of operating personnel, products and the environment to meet the challenges of this development. At the same time, containment systems must be as cost-effective as possible for the manufacturer.
Dr. Martin Schöler, Head of Engineering at Fette Compacting, presented a solution to the Europe Annual Conference of the International Society for Pharmaceutical Engineering (ISPE) in Dublin: The retention performance of a containment plant is determined by Fette Compacting through a risk-based method before shipping to the pharmaceutical company. It is based on a reproducible measurement methodology whose criteria satisfy the ISPE guidelines for containment. The method from Fette Compacting adds additional requirements, customized to the specific requirements of tableting, to those of this standard.
Better containment planning
"The method helps pharmaceutical manufacturers to plan investments in containment systems, reliably and with foresight," explained Schöler in Dublin. "The containment performance of the entire plant, including its processing and safety equipment, is first tested under laboratory conditions. Only then is it assembled at the manufacturer's site under production conditions. The problem is that no empirical data has previously been available about the relationship between the retention performance as determined in the laboratory and the values measured later in practice by the pharmaceutical manufacturer. We want to change that, and we want to make the data for the best possible operative protection available freely." In his presentation, Schöler first set the values determined in the laboratory for a specific containment plant into relation with the practical data from pharmaceutical production. Schöler explained that, "the comparison allows us to draw meaningful conclusions about which criteria in the dimensioning of a containment plant for tablet presses play a significant role, and how it might be possible to avoid the costs entailed by incorrectly dimensioned systems."
Seven steps of measurement
The exposure data obtained are at the heart of the Containment Guards system developed by Fette Compacting. A seven-step measuring process here determines the final exposure of the overall plant. This means that an appropriate containment solution can be found, and the retention performance accurately predicted, even before the operator's subsequent risk assessment.
As far as the user is concerned, Containment Guard meets two crucial criteria: maximum safety and optimum efficiency. It also offers comprehensive service, training and consultation services, precisely matched to the needs of production under containment conditions. With this approach, Fette Compacting is setting new quality standards in pharmaceutical production