Everything under control in laboratory and production

MCP polarimeters are suitable for incoming checks to quickly identify raw materials and for quality control

Pharmaceutical companies work throughout their supply chain in a field which is dominated by regulations and demands for high quality. Defined workflows, trained personnel and reliable instruments and plants are important cornerstones of pharma production. Anton Paar provides a comprehensive product portfolio for R&D, production and quality control.

One of the main fields of use for density measurement is quality control, as it quickly delivers an unambiguous physical parameter as the result. Density gives insight into the condition of pharma raw materials, i.e. media which are currently in the production process, as well as into the finished medicine. This makes it possible to intervene quickly and decide whether the production and the final product are within the defined specifications for continuing the process and approving the product. An added plus is the combination of density and sound velocity measurement, which delivers highly precise and reproducible results for complex three-component solutions. This makes the use of density meters unique for the characterisation and method development of complex liquids in R&D in order to determine common pharma-specific quality parameters. Density measurement is based on the oscillating U-tube principle and corresponds to the requirements of pharmacopoeia such as USP, Ph.EU, JP, MX. This enables direct comparison of results from laboratory and online measurement.

For all relevant wavelengths

The optical rotation is an essential measurement parameter in the pharma industry. It is used to determine the quality and purity of raw materials and for identifying pharma substances. Besides the purity, the first identification of the optical rotation of the used active ingredient is essential because identical molecules with other optical properties may display no or toxic attributes. Manufacturers in the pharma industry have to guarantee and ensure a consistent quality of the medicine so that it poses no danger for the end customer or patient. MCP polarimeters are the ideal instruments for quick incoming checks on raw materials, for reliably identifiying 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.

Refractive index: quickly determined

DMA Generation M density meters are ideal for use in production, predominantly in quality control

The refractive index is a quickly accessible and easy to determine parameter which enables the measurement of different samples. The measuring principle enables measurement of liquids, pastes and solids, as well as turbid, coloured and opaque samples. As the refractive index correlates with the concentration of a dissolved substance, the refractive index measurement can be used to determine the concentration. 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. Abbemat refractometers require no sample preparation and only low sample volumes, and are therefore optimal, time-saving refractometers.

Trace analysis: a clear solution

The various pharmacopoeia dictate that pharma compounds must be investigated to ensure that any heavy metals contained are within the prescribed limits. They also specify the method of sample preparation to be used. The Multiwave 3000 digestion instrument based on microwave technology allows quick and complete acid digestion of different pharma raw materials and end products. Using this digestion instrument enables high sample throughput at homogeneous temperature distribution. The sensors and automatic reports make reactions traceably documented both for the development and validation of methods and for routine operation. To guarantee a sufficient concentration of the substances for analysis and to meet different pharma needs for digestion requires special digestion techniques. The wide range of offered digestion instruments exactly meets these requirements.

Synthesis: from mg to kg

Abbemat refractometers quickly and easily determine the refractive index of batches and allow correction of ongoing production

Conventional organic synthesis, which is the basis for the development and often for the production of pharma components and substances, is a complex, time-consuming and resource-intensive procedure. Using microwave synthesis reduces costs for chemicals and synthesis time. The selected synthesis steps in the small scale can also be optimised during the development process in the multimode reactor. Transfer of the suitable reaction parameters from the small scale to the kilolab scale is now possible with the monomode reactor without adjusting the methods and technology. Microwave-assisted synthesis with the monomode reactor is particularly suitable for the manufacture of expensive and difficult to access pharma agents in small amounts.

Investigating the flow behaviour

The measurement of liquids to investigate their viscous and viscoelastic behaviour is a relevant quality parameter in the pharma industry. It is important to determine the flow properties of formulations, from infusion solutions to ointments, under controlled conditions and to optimise the formulations to ensure that products in production and the finished products have the required properties. Flow properties are dependent on ambient conditions such as temperature and outside forces and also dependent on the different substances which are dissolved in the formulation. If flow properties are outside the limits during production this can result in process steps, such as homogenizing, pumping and filling, running below the required effectiveness or cause changes to active agents. This can result in enormous costs. The size of dissolved particles in pharma compounds, such as infusion solutions, emulsions or creams, is critical in order to ensure that they are infused and transported in the blood flow without pain to the patient or that creams overcome the skin barrier. The MCR rheometers are ideal for defining the flow properties, process parameters and stabilities of the products. The MCR rheometers answer all rheological questions in the pharma sector.

X-ray: From solid to liquid

Using the Monowave 300 microwave reactor, synthesis steps can be optimised in small scale during the development process

X-ray structure analysis gives insight into the internal atomic and molecular structure of pharma active agents and formulations and provides information on the stability of these under different conditions, e.g. different temperatures and levels of humidity. The exact determination of the crystalline structure and the detection of any crystalline impurities in active agents and final medicines are both essential for guaranteeing the medicines’ properties and ensuring flawless production processes. Using the small-angle X-ray scattering (SAXS) system, SAXSess mc2, samples can be measured in both the liquid and solid state and in the final product. The SAXS method gives insight into the aggregation and denaturation behaviour of proteins and also into particle size and particle size distribution in formulations. Structural parameters have a considerable influence on the solubility, stability and shelf life of medicines. A fully automatic small-angle X-ray measurement with SAXSess mc2 makes this complex measuring method easy to use.

Analysis of solid surfaces

Small-angle X-ray scattering systems such as the SAXSess mc2 from Anton Paar give insight into the atomic and molecular structure of active agents and formulations

In the field of medicine, pharma substances should not be affected by the used materials. During dialysis, for example, no substances should diffuse out of the tubes and no substances intended for the patient should be adsorbed by the tubes. The same is required of the containers for pharma products, e.g. infusion bags, glass vials, disposable syringes, etc. The surface of all these materials must not interact with the contained media in order to prevent the impact of the medicine being changed or influenced. In the different steps of pharma production it is also important to ensure that required substances do not adsorb on filters, e.g. when filtering production solutions. The SurPASS electrokinetic analyzer for surface characterisation determines zeta potential and allows investigations into the interaction between the used material and the different components, such as pharma active agents, proteins and different excipients. The used material can then be optimised for the individual requirements.