Pharmaceuticals and biotechnology

Measurement Solutions for the Pharmaceutical Industry

The pharmaceutical and biotechnology industries are important components of a healthy and secure society. They transform raw materials into drugs and vaccines that treat and prevent illnesses in both humans and animals. These industries also convert microorganisms, nucleic acids, and other genetic materials into innovative products for medical care, agriculture, industrial processes, and environmental products, such as enzymes that break down solids during wastewater treatment.

A major concern of the pharmaceutical and biotechnology industry is contamination. Tainted batches are very expensive in terms of lost products and possibly regulatory fines. Manufacturing facilities also lose time when they have to stop production, sanitize the process, and restart. One of the best ways to prevent contamination is to use measurement products that meet or exceed standards for hygiene and cleanability.

Product consistency is also a top priority.

Instrumentation in the Pharmaceuticals and Biotechnology Industry

By monitoring pharmaceutical and biotechnology processes, measuring instruments help ensure quality and safety. Common applications include:

• Temperature sensors and switches in manufacturing and storage facilities, cell growth units, bioreactors, and cleaning processes.
• Pressure sensors, switches, and transmitters in filters, SIP steam boilers, and compressors and hydraulic systems.
• Level indicators and optoelectronic/float switches in mixing vessels, fermenters, storage tanks, and capsule filling machines.
• Compression force transducers and load cells in tablet pressing machines, mixers, materials dispensers, and filling/packaging equipment.

Hygienic Instruments for the Pharmaceuticals and Biotechnology Industry

Any industry that manufactures products intended for human consumption is required to follow rigorous standards and mandates. Noncompliance can result in fines and forced shutdowns. If consumers’ health and safety are endangered, the cost becomes even higher.

Measuring instruments help ensure the highest levels of safety and compliance in sanitary processes. The instruments themselves, especially components in direct contact with the product, must also be hygienic; otherwise, they risk contaminating the media.

Hygienic process connections and other features

WIKA’s gauges, sensors, and switches for the pharmaceutical and biotechnology industries feature the following hygienic designs:

• Corrosion-resistant materials that can withstand the chemicals and high temperatures used in CIP (clean in place) and SIP (sanitize in place) processes.
• No dead spaces or cavities where bacteria can settle and grow.
• Diaphragm seals to isolate the pressure sensor from the media.
• All-welded construction to avoid elastomers that can degrade with time and permit leaks.
• Redundancies and continuous monitoring to warn of possible problems.

An especially innovative product is WIKA’s in-line process transmitter. Its hygienic design features a thick-walled yet flexible sensor tube strong enough to withstands extreme pressure surges, such as ones produced by steam-induced hammers. And since the sensor tube is “dry” and becomes part of the process pipeline, there’s no fill fluid that could leak or no dead spaces to harbor bacteria.

Safety Standards and GMP Guidelines

WIKA has a comprehensive line of pressure, temperature, level, and force instruments for sanitary applications. These products are made following good manufacturing practice (GMP) guidelines and comply with the following regulations and safety standards:

• FDA (Food and Drug Administration)
• ASME BPE (American Society of Mechanical Engineers Bioprocessing Equipment)
• EHEDG (European Hygienic Engineering & Design Group)
• 3-A SSI (3-A Sanitary Standards) · ATEX Directive 2014/34/EU

Mounting is a key part of sanitary instruments. We offer the leading hygienic fittings for the pharmaceutical and biotechnology industry:

• Clamp and tri-clamp DIN 32676, ISO 2852, ASME BPE
• Aseptic connections DIN 11864
• NEUMOBioConnect^® and BioControl^® CS bolt-down process connections
• VARIVENT® flush flange connection

For toxic, bioactive, or very sensitive substances, we have special instrumentation options for integrating measuring instruments without using elastomers.

WIKA also has an extensive program for proof of conformity within the scope of Hazard Analysis Critical Control Points (HACCP), an internationally recognized method for identifying and managing food safety risks. In addition, our calibration equipment and calibration services make sure your measuring instruments are accurate and well maintained.

WIKA USA is your trusted partner for high-quality, reliable hygienic measurement solutions. Click on the Products tab for a list of our pharmaceuticals and biotechnology instrumentation, then contact us for more information and expert advice.

Unique measurement technology for pharmaceutical production

WIKA has worked with licensing and EPC companies for more than 30 years on major projects all over the world. We partner with you from the planning stages through to completion, and we provide post-project support. In addition to supplying high-quality process measurement instruments for temperature, pressure, level and flow applications, we can also work with you to develop solutions that meet your exact requirements.

WIKA also offers on-site expertise and technical support services to help ensure the success of your project. For more information, contact us at 1-888-945-2872 or [email protected].

WIKA USA, part of your pharmaceuticals and biotechnology business

Our success and reputation are built on three factors: a wide and innovative product range, comprehensive services, and a global presence with employees committed to your success. Make WIKA USA part of your pharmaceuticals and biotechnology business.

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.