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Alternative concept

Continuous manufacturing of pharmaceutical products
Alternative concept

Alternative concept
Hosokawa offers different products like the UPZ Ultraplex fine impact mill, the Modulomix continuous modular mixer and the Pharmapaktor for continuous pharmaceutical production
Although the pharmaceutical industry is very innovative in terms of product development, it is quite conservative when it comes to production philosophy. The prevailing philosophy has been around for a long time and is well understood, accepted and validated. Nevertheless, due to the increasing necessity to reduce costs, the pharmaceutical industry has started looking into alternative manufacturing concepts.

Continuous manufacturing of pharmaceutical products

Alternative concept
Although the pharmaceutical industry is very innovative in terms of product development, it is quite conservative when it comes to production philosophy. The prevailing philosophy has been around for a long time and is well understood, accepted and validated. Nevertheless, due to the increasing necessity to reduce costs, the pharmaceutical industry has started looking into alternative manufacturing concepts.
Encouraged by experience in many other process industries, continuous manufacturing is now being explored by industry and academia. The idea of continuous operation – based on known input and understood process parameters – enables the output to be predicted, which is key in life sciences. Regulatory authorities like the FDA therefore favour continuous process development.
The benefits sought in continuous manufacturing are:
  • Compactness (smaller equipment footprint requiring less infrastructure)
  • Reduction in capital expenditure
  • Reduction in operational cost
  • Reduction in inventories
  • Avoidance of scale-up effects
In order to implement continuous production technologies in the pharmaceutical industry, a profound understanding of all attributes is essential. Cooperation between research scientists and engineers in industry working on QbD (Quality by Design) or PAT (Process Analytical Technology) is ongoing.
In most cases, the production of the ingredients like APIs and excipients is separated from the formulation of final products like tablets. Due to the nature of the technologies and Hosokawa’s experience, the company concentrates initially on the secondary process, mainly tableting. The Hosokawa Group can provide integrated processes including milling, mixing and compaction of the powders before the tablets are pressed.
A typical process for direct compression consists of a number of subprocesses which can be combined as modules. First of all, the powders must be milled or micronised to the specified fineness. Various milling technologies are available like impact mills or jet mills, either with or without an integrated classifier. Milling technology is continuous by definition and can hence be integrated in the production line. Sensors to detect particle size distribution (PSD) automatically can also be integrated.
Continuous mixing
In the next stage, the APIs are mixed with excipients. An intensive mixing process is required, especially since the APIs normally have very poor flow properties, though without causing attrition effects. The Hosokawa Modulomix is a versatile unit which is designed for minimum product holdup, to minimise the losses at the start and end of the production run and enable a fast response to process variations.
By tuning the process parameters, the technology is also capable of mixing lubricants like magnesium stearate gently into the formulated mixture. The product is now ready to go into the tablet press.
The homogeneity of the mixture can be measured at the mixer outlet using NIR technology, including facilities for on- and off-spec material.
If the product properties so require (poor flowability), or if the products tend to segregate, a compaction step can be added between the two mixing processes. A range of roller compactors with a proven track record are included in the Hosokawa portfolio. After compaction, the oversize material is crushed or milled.
Feeding is vital
In a continuous product line, feeding the material in the various processing systems is vital. An array of volumetric or gravimetric feeders can be used. Various levels of containment can also be offered for these processes in case of highly active products or hazardous handling.
Hall 4A, Booth 233
www.cpp-net.com search: cpp0116hosokawa

Bert Dekens
Bert Dekens
Application Manager Pharma,
Hosokawa Micron
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