CHEMICAL ANALYSES – WITH EXPERTISE
It's all to do with the chemical composition
Controlling quality by means of chemical analyses is a fundamental and integral element of the pharmaceutical industry. Inorganic element analysis examines samples for trace impurities and the proportions of elements in certain substances. Every investigation is proceeded by developing a method specifically tailored to the product. This demands a high level of expertise and extensive specialist knowledge of the different elements, sample types and disintegration techniques.
Many pharmaceutical companies engage external service providers to carry out their quality assurance. External service providers must, without fail, adhere to the international regulations applicable to manufacturers of medicines. Companies must have their products analyzed by laboratories which have been issued with the relevant GMP certificate by Swissmedic, the Swiss agency responsible for authorizing and monitoring therapeutic products. The accredited analysis service provider will carry out the complex pharmaceutical analysis investigations quickly and reliably. Chemists with many years' experience of the industry and working within a state-of-the-art laboratory infrastructure can provide pharmaceutical companies with the support they need – day by day, project by project.more ...
Routine analytics – Product safety – Product approval
Before receiving approval, every pharmaceutical product must be subjected to the closest examination to ensure that the manufacturing process conforms to the regulatory requirements. Wide-ranging and professionally conducted analysis procedures are required to provide quality assurance of the active pharmaceutical ingredients. Overview analyses and element screening of liquid and solid samples are examples of daily routine activity. The element content determined by these analyses is compared with the specified limits. Further analysis procedures will provide information about the active ingredient content of each product, or may identify any catalyst residues from earlier intermediate synthesis stages.
Rapid, flexible and comprehensive analysis procedures facilitate the high-quality, inexpensive processing of samples. In order to be able to analyze elements with low determination limits in a particular substance submitted for analysis, and also to ensure product safety, the laboratory uses the very latest equipment. It has the necessary certification, the accreditations and the essential knowledge in the field of trace element analysis.
DEVELOPMENT AND VALIDATION OF METHODOLOGIES
Ensuring robust analyses
Every sample is different; every product unique. This also applies to the methodology on which any analysis is based. When developing a methodology, the sample elements to be investigated and their specified limits must be taken into account in addition to the requirements laid down by the authorities. Specialists approach their task in a well-rehearsed and precise manner so as to develop a specific validation methodology for each product, thus ensuring that the data quality is soundly based.
ICH Q3D, the recently implemented medicines directive on limit values for elemental impurities in pharmaceutical industry products, now presents manufacturers of pharmaceutical products with a number of challenges. Companies must equip their laboratories in line with the new requirements in order to demonstrate to the authorities that the elemental impurities in their products are below the required limits. In addition, they have the option of submitting their samples to external analysis service providers, whose appropriately equipped laboratories will ensure that the relevant data is ascertained rapidly and in the correct manner. Suisse TP offers ongoing support to manufacturers of medicines in implementing the new requirements, so that nothing will stand in the way of future product approval.
Moving forward with product developments
Behind every product lies a complex development process. Numerous measurements are taken and many individual decisions made; each product is reviewed again and again. Specialist analysis service providers such as Suisse TP ensure that pharmaceutical companies can keep pace with a constantly changing market. The rapid working practices and the flexible, targeted processes employed by a skilled team ensure short throughput times and speedy approvals. Every sample is examined thoroughly so that subsequent work stages can be planned and carried out without delay.
The analysis support provided to each project is based on a combination of many years' experience and soundly-based procedures. This guarantees constant progress and reliable analyses.
Optimizing products, calculating shelf life
The numerical simulation of product characteristics and of the processes involved in producing pharmaceutical packaging is an efficient way of reducing the time spent on costly testing and can even replace testing entirely. By calculating the shelf life of products (e.g. inhalers) or by optimizing forming or sealing processes, the development process can be speeded up and safety increased when the product is introduced to the market. Predicting moisture absorption (LOD, water kinetics) can significantly reduce the cost of stability testing.
Development is supported by physical and chemical analysis methods which can be used, for example, to describe material properties or to validate numerical simulations.
Patrik Bachmann is a qualified chemist. He completed his apprenticeship as a chemical laboratory technician at Alusuisse in Neuhausen am Rheinfall. He went on to study chemistry, specializing in analytical chemistry at the Zurich University of Applied Sciences in Winterthur. Between 2001 and 2006, he managed several development projects to do with the development of functional aluminum surfaces at Alcan and Novelis. From 2007, he worked in the field of chemical analytics, concentrating on the inorganic element analytics of pharmaceutical samples, and was engaged on analyses of a wide range of materials. Since 2011, Patrik Bachmann has been the team leader and specialist responsible for chemical analytics at Suisse TP.