The NETZSCH Group is a mid-sized, family-owned German company engaging in the manufacture of machinery and instrumentation with worldwide production, sales, and service branches.
When it comes to Thermal Analysis, Accelerating Rate Calorimetry and the determination of Thermophysical Properties, NETZSCH has it covered. Our 50 years of applications experience, broad state-of-the-art product line and comprehensive service offerings ensure that our solutions will not only meet your every requirement but also exceed your every expectation.
The primary objective of R&D and quality control in the pharmaceutical and cosmetics industries is to produce a final product that is safe to use. An important tool in achieving and maintaining a high product standard is Thermal Analysis. For example, using Thermal Analysis can help in investigating and qualifying the characteristics of potential new drugs. Furthermore, it can be used to identify different polymorphic forms in active ingredients.
Thermal Analysis also supports the detection of eutectic impurities and product degradation, and is capable of giving first information about compatibility between various components in a physical mixture when using methods such as Differential Scanning Calorimetry (DSC) or Thermogravimetric Analysis (TGA). The latter method in particular can be applied in determining the shelf life (concerning thermal stability) of a product under a given set of storage conditions.
Such challenging tasks require sophisticated analytical instrumentation. With a view to quality control, it is crucial that laboratories apply well-established, recognised methods on robust and reliable instrumentation that is suitable for operation within the given regulated areas.
The new series Nevio by NETZSCH was specifically designed for the challenges of Quality Control and R&D in the pharmacy, cosmetics and foods industry and by offering the complementary Thermal Analysis methods DSC and TGA in its portfolio. The combination of the two methods, along with the ability to couple gas analyser systems to Thermal Analysis, facilitates interpretation of detected effects.
The NETZSCH Nevio instrument line comes with Proteus Protect, an add-on to the successful Proteus software, which ensures data integrity at a high level and meets the requirements of 21 CFR Part 11 or EU Annex 11.
In regulated areas such as the pharmaceutical or medical device field, it is important to maintain accuracy and consistency of collected data and thus protect them from modification, falsification or deletion. Within the previous years, this topic has increasingly moved into the focus of various supervisory authorities. ALCOA and ALCOA+ are guidelines to achieve a high level of data quality by ensuring data integrity, also regarding electronic records. Nowadays, ALCOA/ALCOA+ are used -amongst others- by FDA and WHO.
All in all, the Nevio line of Thermal Analysis instruments offers benefits along the entire pharmaceutical value chain. The precise, robust and reliable Thermal Analysis instrumentation serves labs with the ability to characterise product ingredients and develop new compounds while providing fully documented workflows.