Anton Paar - Measuring and Analysis Instruments for the Pharmaceutical Industry

Anton Paar produces high-quality measuring and analysis instruments for industrial and research applications. Its product portfolio includes density and concentration meters for both laboratory and process, viscometers, rheometers, polarimeters and refractometers, as well as instruments for X-ray structure analysis, microwave synthesis and microwave decomposition.

Evaluation of optically active substances

MCP polarimeters measure the optical rotation of substances. They are the ideal instruments for quick incoming checks on raw materials, for reliably identifying correct substances during production and in the final product as part of quality control. The Propol online polarimeter enables real-time monitoring of the correct production and formation of an active ingredient in the correct chirality.

Concentration and refractive index measurement

Refractometers measure the refractive index, which correlates with the concentration of a dissolved substance. For quality control laboratories in particular, it is important to have reproducible results available simply and quickly for the approval of batches or correction of the ongoing production.

Density measurement for quality control

Density measurement gives insight into the condition of pharmaceutical raw materials, as well as into the finished medicine. Anton Paar offers a broad range of density meters: three-digit accuracy for quick, portable measurements on-site up to highly accurate six-digit accuracy for fully automated measurements in the lab. An added plus is the combination of density and sound velocity measurement in one instrument, which delivers highly precise and reproducible results for complex three-component solutions. Density measurement is based on the oscillating U-tube principle and corresponds to the requirements of pharmacopoeia such as USP, Ph.EU, JP and MX.

Determining the viscosity of formulations

Viscosity determination is used to define the optimal flow behavior and appropriate stability range for liquid formulations and excipients. The Lovis 2000 M viscometer determines the dynamic, kinematic, relative and intrinsic viscosity of liquids. It can determine, for example, a protein's ability to crystallise and denaturise. Lovis 2000 M is ideal for QC on valuable active agents as it requires only 0.1mm of sample.

Synthesis: from mg to kg

Using microwave synthesis reduces costs for chemicals and synthesis time compared to using conventional organic synthesis. With Monowave 300, Multiwave PRO, and Masterwave BTR Anton Paar provides a versatile family for microwave synthesis applications, serving applications from the smallest quantities up to the liter scale. Transfer of methods from R&D to kilolab scale is easily possible due to accurate measurement of the reaction temperature.

Investigating the flow behaviour and composition

The measurement of liquids to investigate their viscous and viscoelastic behaviour is important in order to determine the flow properties of formulations under controlled conditions and to optimise formulations to ensure that products have the required properties. The MCR rheometers are ideal for defining the flow properties, process parameters and stabilities of the products.

Qualification and validation of instruments

For defined instruments Anton Paar offers an instrument-specific qualification and validation package to meet the strict pharmaceutical regulations. This package covers all steps to perform a complete instrument qualification: DQ, IQ, OQ, PQ, Risk Analysis, 21 CFR Part 11 checklist, Deviation List, Traceability Matrix and SOP. Certified Anton Paar representatives assist in the whole qualification and validation process if required.

Monitoring products directly in the production process

The analysis of process-sensitive parameters provides insight into the real-life conditions of products in the pipeline. Controlling the production process at every stage contributes to optimising the production and output, which subsequently results in efficient use of raw materials, excipients and APIs as well as environmental resources. Anton Paar provides process instrumentation for density and concentration measurements, viscosity determination and a unique solution for determining optical rotation.

Surface analysis with zeta potential

Anton Paar's SurPASS determines the solid surface zeta potential. The instrument is used to investigate materials such as polymers, glass or metal surfaces of medical drip tubes, hemodialysis membranes, or containers for drugs. SurPASS helps to determine whether components, such as APIs, additives and proteins, adsorb on the material's surface.

Microwave-assisted sample preparation

Trace element impurities influence shelf life, stability, and safe use of the final product. Regulations require pharmaceutical manufacturers to determine impurities at (ultra-) trace levels (i.e. USP <232>, <233>). Anton Paar's microwave-assisted sample preparation instruments provide complete digestion for the analysis of impurities (i.e. heavy metals) in APIs, formulation agents, and solvents, regardless of their formulation or chemical structure.

Investigations into structural behaviour

Small-angle X-ray scattering allows the non-destructive investigation of the structural behaviour of materials, such as active pharmaceutical ingredients, proteins, emulsions and dispersions, in the nanometre range from 0.12nm to 200nm. Anton Paar's SAXSpace system is used to investigate pharmaceuticals in the solid and liquid state. These structural parameters can influence the thermal stability, solubility, dissolution times and the compactness, which can influence the shelf life of pharmaceuticals during storage and transport.