How pharmaceutical producers keep an eye on particle properties

Over 360 companies with offerings specifically for the pharmaceutical industry are expected at POWTECH 2017.

When the trade fair POWTECH in Nuremberg starts on September 26, 2017, solutions for the pharmaceutical industry will once again play a prominent role. After all, the leading trade fair for mechanical process engineering, handling, and analysis of powders and bulk materials is all about grinding, mixing, dosing, agglomerating, and more – processes that are also essential in pharmaceutical manufacturing. In addition, particle measurement technology is a key segment of the POWTECH exhibition. Visitors from the pharmaceutical sector will also benefit from a particularly extensive technical program in the dedicated industry forum Pharma.Manufacturing.Excellence and the special exhibition Pharma Solids.

Particularly in solid dosage form manufacturing, the pharmaceutical industry presents special challenges for particle measurement technology. The active and excipient substances used in the formulation of solid medicines are usually available as powders or granulates and exhibit a wide range of physical properties as collective particles. Individual particle properties such as size, shape, and their distribution determine the characteristics of the collective, e.g., in terms of fineness, specific surface area, bioavailability, flow behavior, compaction ability, dosing accuracy, or dispersibility. These properties are critical quality attributes for the production of safe and therapeutically effective solid dosage forms. The particle size distribution and particle shapes must be measured regularly and reliably as critical control parameters to ensure consistent quality of intermediate and final products.

Measurement from the laboratory to the process

Dr. Torsten Hübner, Sales Director Europe at Sympatec GmbH, clarifies: “The requirements for particle measurement technology in solid dosage manufacturing mainly include the repeatable application of established measurement methods and reliable, comparable results – both in the laboratory and in the process. The measurement technology used should support all stages from development to large-volume production: manual measurements in research and development laboratories, process-related measurements in pilot or technical scale plants, up to high-frequency measurements in automated laboratory environments, and continuous real-time measurements for controlling and monitoring large-scale production facilities.”

Referring to the fulfillment of regulatory requirements derived from GMP guidelines and other approval authority regulations, Hübner adds: “In the pharmaceutical environment, compliance with all regulations is assumed. This particularly concerns instrument design in particle measurement technology, which supports safe handling of active ingredients and prevents cross-contamination during manufacturing. Reliable in-process control options to implement the Quality by Design initiative are gaining further importance. But also, the validation and qualification of measurement systems, as well as the requirements for the safety and traceability of measurement data documented in software and their authentication, must be met.”

A broad range of products for pharma

Sympatec will showcase the entire spectrum of its modular, product-specific, and – as Hübner emphasizes – “user-friendly technologies for particle size and shape analysis from laboratory to production” at POWTECH 2017. In addition, the company will present flexibly adaptable sampling and dispersing systems and introduce their new application software PAQXOS. Besides Sympatec, more than 360 exhibitors at POWTECH 2017 will specifically present products and innovations for the pharmaceutical industry. Many other booths will also feature solutions with cross-industry applicability. Overall, around 900 exhibitors are expected at POWTECH 2017 across six exhibition halls.

Expert knowledge with a focus on solids

Visitors can experience tangible pharmaceutical production technology in Hall 3A at the special exhibition “Pharma Solids.” Over 300 square meters, more than 20 device innovations from different providers will be presented, organized according to the process steps grinding, comminution, particle analysis, sieving, and weighing. Those wishing to deepen their knowledge of pharmaceutical solid production are encouraged to attend the accompanying seminar series on the topic, organized by the Pharmaceutical Process Engineering Working Group (APV) for POWTECH. The special exhibition is also followed by the Pharma.Manufacturing.Excellence forum, which offers a broad and free lecture program on pharmaceutical manufacturing.

A current list of exhibitors and further information about the POWTECH program can be found at: www.powtech.de