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Advantages of continuous manufacturing for the whole process

06/11/2018

June 11th, 2018, Paderborn/Frankfurt – Achema 2018: With a complete, virtually realized multi-level production line, Lödige Process Technology will be demonstrating at Achema the characteristic strengths of continuous systems which may also find the interest of oral solid drug manufacturers.

Cost-effective manufacture of large product volumes was hitherto seen as the key argument in favour of continuous manufacturing processes. But there are a number of other advantages that weigh considerably in the pharmaceutical industry and make their use interesting for smaller throughputs. For example, these processes promise consistent product quality, enable smaller machines and involve less cleaning.
As a specialized vendor of machines for mixing, granulating and drying solids, Lödige has been implementing continuous solutions for many industries since the 1950s. Since that time the company has consistently enhanced its pharma-specific portfolio. Today, Lödige can realize the complete tablet production process – from the raw materials to the tablet-capable granulate.

Two basic manufacturing processes

Two basic manufacturing processes are available for the purpose:
1. In direct compressing the necessary components are fed into the process by container, big bag or small components via sack chutes. They are then transported by use of loss in weight feeders according to the specific composition, in the first step a continuous mixer creates a homogeneous mixture. The mixed product was either transported by gravity use or with pneumatic transport systems to the tablet press. Depending on the properties of the product, further machines may come into play between the mixer and tablet press, e.g. roller compactor.

2. In continuous wet granulation the first two steps are identical to direct compressing. However, following the mixing stage the product must be moistened and granulated. The granulate is then dried in a continuous fluid bed processor before it is pressed into tablets in a tablet press.

 

In both manufacturing processes different measuring points (PAT) are installed at all process stages in order to ensure that the quality of the product can be monitored and documented at each point in the process.
Beyond the pure mechanical components, control software plays a major role in continuous production. During operation it reconciles all measured parameters with the specified values, in order to intervene and make the necessary readjustments in the event of deviations. Furthermore, it ensures that in the case of non-conformance with specifications the system stops and does not restart until the fault has been corrected.
In addition to regulating the manufacturing process itself, the control unit must guarantee seamless tracking of the manufactured tablets. Huge data volumes must be processed and stored for the purpose.

Continuous machines and systems with pharma-specific design
All continuous machines and systems can be supplied in the pharmaceutical industry upon fulfilment of the relevant GMP requirements. Machine and clean room areas must be structurally separate (black/white separation), and an integral cleaning function and fast access for easy inspection should be part of the complete line design too.

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