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Glatt GmbH

DÜPERTHAL Sicherheitstechnik GmbH & Co. KG

Glatt Ingenieurtechnik GmbH

Italvacuum, Srl

Traceability is a key

Back to Modcos. But what makes the continuously operated process plant from Binzen different from the rest of the world? “We have achieved a high degree of flexibility so all the necessary process steps can be organized in any sequence to produce a tablet”, says Thies. This also includes the necessary integration of measurement of quality parameters (PAT).

A big issue in continuous production is that of pharmaceutical safety. For a validated process, the pharmacist must know precisely what production stage the processed material has reached at a given position and process time. That is why Traceability must be guaranteed and documented. It is not a problem in batch systems but how will a practical solution look for a continuous process? Residence-time distribution and residence-time check are the key concepts, which the Xaver Knöpfle, Process and Systems Developer, brings to Glatt in Binzen.

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Back mixing cannot be completely ruled out back-mixing in the continuous processes, however, by knowing the residence time and its distribution, complete traceability is possible. In principle even in today’s production many steps proceed almost continuously, emphasises Thies. Here small changes in important details are new, e.g. interfaces and communication of individual process steps and regulation of quality parameters over several process steps.

The basic operations themselves do not change. Drying remains drying and granulation remains granulation. Thies refers to a unique selling point of the Modcos-System, modularity. Currently, the method of choice for continuous granulation processes in pharmaceutical development is wet granulation using a twin-screw extruder. Glatt has partnered with Thermo Fisher to offer twin screw wet granulation as an option on the Modcos system.

Other continuous granulation methods are also available such as a continuous fluid bed granulator or a single shaft flow granulator.

“With the Modcos-process application we are offering an elegant option to upgrade the existing fluidised bed systems such as GPCG 2 and 10 to continuous production and integrate them in a continuous process chain”, explains the Development Manager. To exploit the full potential, the pharmaceutical companies are concentrating on applying continuous strategies to new or redeveloped products.

Product development and production merge when a continuous process strategy is implemented. Scale-up becomes easier and the new process is also lowers costs and is less expensive. “From the total investment perspective, continuously operated process plants are somewhat more expensive to purchase in the beginning when compared to batch systems but their strength lies in routine operation which is more efficient and enables lowers cost production over time”, explains Thies.

He puts forward another cost argument by mentioning the significantly reduced space requirement in the field for continuously operated process plants than batch systems. This means a smaller clean room footprint and lower infrastructure requirement. All in all, this means reduced operating expenses.

Why Implementing PAT?

Continuous production not only means the implementation of a complete process, it also requires detailed process knowledge for control and the potential to implement Real Time Release. It does not work without implementing PAT.

Thies explains: “For construction of a Modcos system, the quality-determining process parameters and the corresponding measurement points are defined according to the process request. If required, a process parameter can also be measured at several points.” Apart from the product temperature, three important quality-determining process parameters are the homogeneity of the mixture, the particle size and its distribution as well as product moisture which can be controlled with corresponding PAT-systems.

PAT-systems on Modcos have been developed and are integrated by preferred Glatt Partners with the necessary experience of their technologies. If preferred by the customer, measuring systems of other manufacturers can be used. All measured process parameter is stored and can be assigned using Traceability for every stage of the process. During the entire development of Modcos, Glatt has been focused on partnerships.

This is not only applicable for the integration of the process analytics tools but for example also for the dosing technology and the extruder technology. The gravimetric feeder is from Coperion and the extruder technology for the wet granulation is from Thermo Fisher. For tablet-production, tablet press technology from fellow Excellence-United-Partner Fette Compacting can be used.

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