Pharmaceuticals and biotechnology

Measurement technology for the pharmaceutical industry

In view of the high demands on the quality and product safety from pharmaceutical production, sterile process engineering plays a significant part in the cost-effectiveness and safety of the production processes, in both upstream and downstream areas. Even in the further course of the process chain, up to cleaning and sterilisation, contamination-free processing is a crucial quality factor. From measuring instruments, this demands a combination of the most up-to-date hygienic design and, at the same time, a high measurement accuracy.

Are WIKA measuring instruments GMP-compliant?

Measuring instruments from WIKA are manufactured in line with the GMP guidelines (good manufacturing practice). They meet the stringent requirements of, e.g.:

• FDA (Food and Drug Administration)
• EHEDG (European Hygienic Engineering & Design Group)
• 3-A Sanitary Standards, Inc.
• ASME BPE (Bioprocessing Equipment)
• ATEX (directive 94/9/EC)

For conformity verification with certification through the FDA and national authorities, we have a comprehensive programme of certificates available. For the ongoing testing of the measuring instruments in the context of quality management, a wide range of calibration equipment and calibration services are available.

Which process connections are available for integration into pharmaceutical process plants?

WIKA supplies a wide range of industry-standard and manufacturer-specific process connections in hygienic design, for example:

• Clamp connections, TRI-CLAMP^®, DIN 32676, ISO 2852, ASME BPE
• Aseptic connections DIN 11864
• NEUMO BioConnect^®, BioControl^® and elastomer-free ConnectS^®, BioControl^® CS
• VARIVENT^®

Which instrumentation options are available to integrate measuring instruments into plants?

For toxic, bioactive substances or very sensitive substances, special instrumentation options are available in order to integrate the measuring instruments into the plants without elastomers.

Unique measurement technology for pharmaceutical production

WIKA has been active in the contractor business for more than 25 years. Together with international engineering companies we realise large projects all over the world, being more than simply a reliable supplier of high-quality process instrumentation and measurement technology: We develop – together with you – products and solutions made custom-fit to your requirements.

During all phases of the project WIKA remains your competent partner: Starting with planning in the basic and detail engineering, through realisation and implementation of the project, all the way to the after-sales support.

The factors of high-level performance

WIKA’s high level of performance is based essentially on three factors: A wide and innovative product range, comprehensive and competent service and reliable global presence. We are happy to assist in your success.

How do WIKA measuring instruments contribute to safety and efficiency in the pharmaceutical and biotechnology industries?

WIKA measuring instruments offer precise and reliable measurements that are crucial for processes in pharmaceuticals and biotechnology. Whether it is to monitor the pressure in a bioreactor, control the temperature during fermentation or ensure sterility and hygiene – WIKA’s high-quality instruments ensure accurate monitoring and control, resulting in improved products and drugs.

What makes the chemical-pharmaceutical industry different from pharmaceutical biotechnology?

In the production of pharmaceuticals, a distinction is made between two main process principles:

• The chemical synthesis based on chemical reactions to produce active ingredients. It enables the production of pharmaceutical active ingredients with relatively low molecular weight in large quantities and in a short time. In addition, various chemical modifications can be used to increase the activity of the produced substances. In addition to the actual raw materials, solvents and other flammable substances are frequently used as well, which requires fire and explosion safety of the plants and thus also of the measurement technology. In many cases, there are corrosive liquids involved, too, requiring the use of special materials.

WIKA offers an extensive range of measurement technology for the chemical industry.

• Biotechnological processes are based on the ability of microorganisms and cells to produce pharmaceutical substances. The cells are grown in bioreactors. Living organisms or their products are used to modify living or non-living matter in order to produce active ingredients.

WIKA offers an extensive range of measurement technology for biotechnological processes.

What role do molecular biology and chemistry play in drug development?

Molecular biology explores the molecular mechanisms and interactions within cells, including DNA, RNA and proteins, leading to the discovery of new therapeutic approaches. Chemistry is the basis for the formulation, synthesis and analysis of these potential drugs.

How do bioprocessing and bioreactors contribute to biotechnology?

Fermentation is a process where microorganisms are used to produce valuable products or convert substances. In bioreactors, biological reactions occur under controlled conditions, often with a mixture of cells, nutrients and other necessary substances.

Why are sterility and hygiene crucial in pharmaceutical production?

Sterility and hygiene ensure the safety of drugs, vaccines and other products. Strict hygiene prevents contamination by unwanted microorganisms, while sterility ensures that products such as drugs are free from any harmful germs.

In the complex world of biotechnological production processes, sterility and hygiene play a decisive role. A bioreactor is a central component in the upstream process of modern pharmaceutical production processes, in which microorganisms and cells are cultivated under controlled conditions in order to produce active ingredients and drugs.

The pharmaceutical products must meet the highest quality standards to ensure consumer health and safety. Even the smallest contaminations can have serious consequences and impair the effectiveness of the drug.

The microorganisms need optimal conditions in order to grow, to divide and to produce the desired products. Any contamination by foreign organisms can affect the entire production process and lead to significant losses.

The pharmaceutical processes require a high level of cleanliness. Any contamination by bacteria, viruses or other microorganisms can impair the quality of the end product, possibly leading to serious health risks for the patient.

Therefore, compliance with stringent sterility and hygiene standards is crucial. This includes, among other things, the implementation of control measures to prevent contamination. Strict compliance with these standards is essential to produce high-quality, safe and effective drugs.

Our WIKA measuring instruments can help to minimise risks.