High-tech in the Pharmaceutical Industry

How the inventor of antiseptics moves into the future with the most modern measuring and analysis technology

Preventing diseases before they occur – this is the mission that Schülke&Mayr, a pharmaceutical company in Norderstedt, Germany, has been dedicated to since 1889. Founded after the cholera epidemic in that year, the producer of the world’s first antiseptic has since expanded to 12 locations worldwide. In the interest of sustainability and in the course of standardizing laboratory equipment, the company replaced instruments like rheometers, density meters, and refractometers with these products from Anton Paar. With these instruments, the tradition-steeped pharma company will continue to grow and assert itself on the global market.

Diseases have been a burden for mankind for thousands of years. Billions are invested not only in fighting them, but also in prevention. Antiseptics and other pharmaceuticals are key elements of this fight. For more than 125 years, Schülke&Mayr has been involved. The company based in Hamburg launched Lysol, the world’s first disinfectant, in 1892. The innovation was driven by the dreadful impact of a cholera epidemic three years earlier. Today the company still produces antiseptics, but also cosmetics, body care, washing lotions, and special additives.

Continuous development and high product quality are at the core of the corporate philosophy. To launch future-proof products Schülke&Mayr has been relying on Anton Paar measuring instruments in all fields, from research and development to production and quality control, since July 2015. Two different rheometers are in use as well as combinations of density meters with refractometers. They measure viscosity, density, refractive index, stability, and the structure of samples of various consistencies. The Anton Paar Pharma Qualification Package supports the fast and compliant use of all these instruments.

Convenient laboratory routines: consistent methods, ease of use

Due to its product portfolio, Schülke&Mayr analyzes samples from low to high viscosities like solutions, gels, creams, and suspensions, sometimes even 24/7. In the production sector 20 employees work with the MCR 102 rheometer six days a week in three shifts. In quality control ten employees work on it in two shifts, 15 hours a day on working days. They also operate the density/refraction combinations. “All our instruments from Anton Paar are easy to use for our laboratory staff,” says Stefan Jordan from the department for process technology and safety at Schülke&Mayr. The company also plans to equip the production sector and research and development department with a DMA 4500 M density meter and an Abbemat 300 refractometer in 2017.

“We approached Anton Paar because we were not satisfied with the service provided by our previous rheometer provider. We were looking for a reliable partner which solves problems, supports us with good advice, and has short reaction times,” Stefan Jordan continues. Part of this partnership was, among other things, a workshop for the rheometer software RheoCompass™ for approximately 15 participants, who had an intensive learning experience. “The workshop and support made the change to a new software interface very easy,” Stefan Jordan says. Method transfer and development were very straightforward as well. “Especially for the rheometer, Anton Paar designed the methods together with our research department. Our research staff attended seminars at Anton Paar and now they can teach our employees in process technology.”

The highest qualification standards

“We compared Anton Paar’s qualification package to those from other manufacturers and consider it to be extremely comprehensive,” says Stefan Jordan. “It covers all the steps that are required by norms and regulations. It is very precise and also passes the FDA inspection easily.” Even the Korean pharmaceutical authority – known for being rigorous –, which recently conducted an audit at Schülke&Mayr, was satisfied with the documents. That is a big advantage according to Stefan Jordan. “The Korean pharmaceutical authority is regarded to be the most important one in Asia. Those who meet their requirements can place their products in almost the entire Asian market.” Except for Asia, where they are waiting for authorization, Schülke&Mayr sells their products worldwide.

However, there is more to pharma qualification than instruments and methods meeting the regulations. The documentation of measuring results also has to meet high standards. “For all our Anton Paar instruments – rheometers, density meters, and refractometers – qualification is consistent and equally clear,” Stefan Jordan explains. The documents are state-of-the-art. For example, they already contain a risk analysis. Another factor that positively influenced the decision in favor of Anton Paar was the traceability matrices. They are used for the final check of whether all documents are available and signed correctly or whether there are any deviations.

Use in research

The MCR 302 rheometer is also used in the field of R&D. Apart from viscosity determination and stability analyses also structure determination is done. “We observe how the structure of samples changes over time in order to gain as much information as possible from the sample, which enables quicker developments afterwards,” says André Lemke, project manager of antisepsis development in the area of R&D at Schülke&Mayr. “In this way we can be much quicker in arriving at statements about the changes of the samples and their influence on other parameters such as stability.”

The research and development department makes full use of the possibilities MCR 302 offers, as Lemke describes: “Low-viscosity Newtonian fluids are mostly measured using the cylinder. When we measure emulsions, for example, we use the cone-plate geometry and choose the size depending on the viscosity of the emulsion. Because we also measure dispersions, we have parallel-plate geometries as well. Further, clarifying the structure of hydrogels or alcoholic gels is part of our work, for example based on yield points. In this way we learn as much as possible about our products and quickly recognize potential for improvement.”

In recent years Schülke&Mayr has taken various steps to improve sustainability. Apart from saving energy they focused on an environmentally-friendly production of the pharmaceuticals. The acquisition of the new laboratory instruments is also a sustainable investment. Because of the compatibility of the instruments in all three labs – R&D, production, and quality control – methods and results can be smoothly transferred and used from one stage to another throughout the entire development process of a product. The qualification documents and the qualification service contribute to a quick and compliant use of the new instruments and, due to re-qualifications, these documents accompany the instruments throughout their working life. Hence, Schülke&Mayr has laid a future-proof foundation – a solid basis for the next 125 years of company history.

For more information on the documentation required for compliance, Anton Paar is happy to help.

Picture 1: A gel-like sample is applied to the plate of the MCR 102 rheometer.

Picture 2: Easy handling of the DMA 4500 M density meter combined with the Abbemat 300 refractometer simplifies lab routines.

Picture 3: In July 2015 Schülke&Mayr switched to lab equipment from Anton Paar. Since then, three rheometers (two MCR 102s, one MCR 302) and two density/refraction combinations, of which more are about to follow, have been in use.

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