NETZSCH
Grinding And Dispersion Excellence, Delivered

Solubility—a critical measure within the medical sciences—plays a vital role in enhancing the effectiveness of drugs while allowing companies to achieve the desired pharmacological response for the particular use case. And, in order to attain the required solubility index, pharmaceutical companies are required to formulate the precise particle size of the Active Pharmaceutical Ingredients (APIs) and achieve an efficient synthesis of relevant raw materials, alongside establishing accurate measuring/testing capabilities. “Pharmaceuticals should be effective, fit for use, not contain impurities, be stable enough and easy to administer. This places high demands on the selection of the right mixing & grinding technology and relevant process parameters in combination with the different raw materials (APIs and excipients) and formulations. We provide clients with all of these essentials,” begins Sven Hoffmann, Product Manager SystemVita, NETZSCH Vakumix GmbH.

Upholding the promise of exceptional performance, NETZSCH Vakumix GmbH—a part of the family-owned NETZSCH Group—offers a vast portfolio of solutions for (dry and wet) Grinding & Dispersion, De-aeration, Analysis & Testing, and Mixing & Classification functions, all of which represent the higher order of customizability. Specialized in machine design and procedures that customers would need to create products under the highest standards (according to the standards of GMP), the company can tailor its solutions based on the clients’ suggested process parameters or machine specifications, and so forth; the comprehensive portfolio of solutions enables clients to process of APIs from the smallest to the large production scales. Hoffmann adds, “With the smallest device, the processing of smallest samples with less than 1 ml is possible. The results from those investigations can be qualitatively transferred to any production scale. That means, with NETZSCH, our customers can start in the earliest stage of research and development, and NETZSCH specialists support the process from R&D to the real production.”

Hoffmann’s words are validated by NETZSCH Vakumix’s , which develops formulations with minimal sample amounts of less than 1 ml, all the while processing up to 40 samples at the same time. With universal applications spanning Liposomes, Suspensions, and Emulsion, transcends the limitations of the traditional planetary mill, both in terms of volume of production and particle size of APIs. Alongside the the company also offers rotor/stator homogenizer, vacuum mixing equipment, high-pressure homogenizer, agitator bead mill, and especially the combination of different technologies as SystemVita. Through these diversified solutions, the company assists clients in invalidating the right process for relevant APIs in the early development phase to ensure that the production does not encounter hindrances further down the line.

Such guidance plays a pivotal role in the early development stages/screening procedures when API availability is scarce. Of course, this support is also available at a larger scale; for example, when moving from technical batches to the production scale.

The company’s ability to deliver such a diverse range of services can be attributed to its leadership and in-house specialists that have honed expert knowledge on the clients’ discrete requirements, be it related to pharmaceutical applications, food and beverages, or mining. To that end, Hoffmann says, “What is very unique to the NETZSCH Group is that we have different specialists in the market that are experienced in grinding, mixing, and homogenization as well.” These specialists possess the necessary expertise on both the process and the equipment involved, which helps in the development and manufacturing of custom design solutions in tests across cleanroom laboratories. To grant the required corroboration to its customized solutions, the company’s specialists provide several process validation certificates such as FAT (factory acceptance test), IQ (installation qualification), and OQ (operational qualification).

Pharmaceuticals should be effective, fit for use, not contain impurities, be stable enough and easy to administer. This places high demands on the characterization and production of raw materials (APIs and excipients) and formulations

Highlighting one of the many capabilities offered to clients, Hoffmann says, “Thermal Analysis techniques, especially Differential Scanning Calorimetry (DSC) and Thermogravimetric Analysis (TGA) are widely used to investigate drugs by determining their physicochemical properties, studying polymorphism phenomena and the compatibility between APIs and excipients, or by detecting their thermal stability and – in combination with gas analyzing systems – identifying residual solvents. Rotational rheometers are very close to the final application of pharmaceuticals and help producers, for example, develop dermatological creams with optimal spreading or find the right flowing properties of nasal sprays, which are then produced on our technologies, like rotor/stator homogenizer or agitator bead mills.” The aforementioned use case exemplifies the myriad of consolidated capabilities provided to clients by the NETZSCH team through collaborations. This workforce, spanning 36 countries, works closely with clients to provide after-sales service, consultations, training, and the like, and thus, delivering on its promise of delivering uncompromised, performance-driven solutions.

Observing NETZSCH’s success trail and exemplary range of turnkey solutions, it is safe to say that the company has carved a niche in the industry, in addition to the effective characterization and production of raw materials while helping clients precisely deduce the appropriate formulation for specific pharmaceutical products. The results achieved through its products remain unparallel to date, and hence, validate the company’s position as the go-to partner for clients who provides the most sought-after assistance in finding the right process for their pharmaceutical product.