How Pharmaceutical Manufacturers
Keep an Eye on Particle Characteristics
Solutions for the pharmaceutical industry will once againn play a prominent role at this year's POWTECH trade fair, which opens inn Nuremberg on 26 September. After all, the leading trade fair for nprocessing, analysis, and handling of powder and bulk solids is all nabout grinding, mixing, measuring out, agglomerating, etc. - in other nwords, essential processes in the manufacture of pharmaceuticals. nParticle measurement is also an important element in the exhibitions at nPOWTECH. Visitors from the pharmaceutical sector will also benefit from an particularly extensive supporting programme in the form of the trade nforum Pharma.Manufacturing.Excellence, which was created especially for nthe sector, and the special show "Pharma Feststoffe" (Pharmaceutical nSolids).
In the area of solid product manufacture, in particular, the pharmaceutical industry sets some quite specific challenges for particlen measurement technology. The active ingredients and excipients used in the formulation of solid drugs normally come in powder or granulate form, and display a very wide range of physical properties as an assemblage of particles. Individual particle properties such as size, shape and distribution determine the properties of the whole, e.g. in terms of fineness, specific surface area, bioavailability, flow behaviour, compactability, metering accuracy and dispersibility. These properties are critical quality features for the manufacture of safe and therapeutically effective solid drug forms. Regular and reliable measurement of critical parameters such as particle size distribution and particle shape is essential, if interim and end products of uniform quality are to be guaranteed.
Measurement, from laboratory to process
Dr Torsten Hübner, Head of Sales Europe for Sympatec GmbH, explains: "The demands on particle measurement technology in the manufacture of solid products essentially involve the repeatable use of established nmeasurement methods, along with robust and thus comparable measurement results - both in the laboratory and in the process. The measurement technology to be used should also support all stages from development through to high-volume production: manual measurement in the R&D laboratory and measurement in pilot plants, through to high-frequency measurement in automated laboratory environments and continuous real-time measurement for checking and control of plants involved in high-volume production."
With reference to meeting regulatory requirements resulting from GMP guidelines and other requirements set down by the registration authorities, Hübner adds: "In the pharmaceutical world all requirements have to be met. For particle measurement technology, this relates particularly to instrument design, which helps to ensure the safe handling of materials and avoid cross-contamination during the manufacturing process. Opportunities for reliable in-process monitoring to implement the Quality by Design initiative are growing in importance.
"But it's also necessary to validate and quality-check measurement systems and requirements in terms of the safety and traceability of the measurement data documented in the software and its authentication."
Broad spectrum of products for the pharmaceutical industry
At POWTECH 2017, Sympatec will exhibit its entire range of modular, product-appropriate and, as Hübner emphasises, "user-friendly ntechnologies to analyse particle size and particle shape, from laboratory to production." Sympatec will also take flexibly adaptable sampling and dispersing systems along to Nuremberg and exhibit its new PAQXOS application software. Sympatec is one of more than 360 exhibitorsn at POWTECH 2017 that will have products and innovations on offer for the pharmaceutical industry. And at many other stands, trade visitors will also find solutions for use in a wide range of other industries. Altogether, some 900 exhibitors are expected at POWTECH 2017, in six exhibition halls.
Professional knowledge with a focus on solid materials
"Bundled pharmaceutical manufacturing technology up close" will be navailable for trade visitors to experience in hall 3A, at the special show "Pharma-Feststoffe" (Pharmaceutical Solids). In an area of more than 300 m², more than 20 device innovations from various suppliers will be on display, grouped by the different process stages: grinding, crushing, particle analysis, filtering and weighing. Visitors seeking ton learn more about the manufacture of pharmaceutical solids will benefit from the accompanying series of workshops arranged especially for POWTECH by the International Association for Pharmaceutical Technology (APV). The special show will also be accompanied by the Pharma.Manufacturing.Excellence forum, which will offer a broad range of free presentations on pharmaceutical manufacture.
Images: R. Eberhard, messekompakt.com, EBERHARD print & medien agentur gmbh