Aseptic applications safely under control
The integrity of your processes is crucial to the quality of your products in the pharmaceutical, biotechnology and cosmetics industries. Our valve solutions ensure that your media are controlled safely and precisely – for reproducible processes, reliable system operation and the highest possible product quality.
In the pharmaceutical, biotechnology and cosmetics industries, process integrity and process control are top priority. We support you in creating processes that combine hygienic and aseptic requirements, statutory requirements and operational efficiency.
Our valve designs and plant components are designed to meet the most stringent requirements for aseptic applications, sterility and cleanability. They enable precise control and regulation of critical process media, contribute to safe and compliant plant operation, and form the basis for consistently stable processes and assured product quality in a highly sensitive environment.
In the upstream process, micro-organisms or cells are cultivated to produce high-quality active substances, enzymes, proteins or vitamins. Precise control of temperature, pH value, oxygen and nutrient supply, as well as aseptic or hygienic process management, are crucial to ensuring stable processes and optimal yields – as a basis for the subsequent downstream process.
Aseptic applications have stringent requirements for valves – from their chemical resistance and easy-to-clean surfaces to compliance with regulatory requirements. Stainless steel diaphragm and diaphragm globe valves meet these requirements and ensure safe and hygienic switching between operating states.
Small volumetric flows of nutrient media and oxygen are precisely controlled using suitable control valves, reliably ensuring accuracy, reproducibility and product quality – as demonstrated by the BioStar aseptic diaphragm globe valve GEMÜ 567.
The growing demand for sustainable and personalized products, as well as technological innovations, are driving development in the pharmaceutical industry. Biological medicinal products and customized therapies require controlled bioreaction. Digital technologies, automation systems and AI-supported process optimization will make bioreactions more efficient, controllable, scalable and flexible. This allows production costs to be reduced while maintaining high product quality in order to remain competitive in the long term.
Production involving living cells or micro-organisms is subject to special requirements: High media costs, long production times and sensitive media can lead to considerable costs in the event of contamination. Flow- and dead space-optimized multi-port valve blocks made from suitable materials help to reduce process fluctuations. Intelligent valves with feedback function provide indications of deviations and thus support compliance with sterility, efficiency and stable product quality.
Production involving living cells or microorganisms is associated with special requirements: high media costs, long production times, and sensitive media can lead to considerable costs in the event of contamination. Dead space and flow-optimized reusable valve blocks made of suitable materials help to reduce process fluctuations. Intelligent valves with feedback functions provide information about deviations and thus support the maintenance of sterility, efficiency, and stable product quality.
In the pharmaceutical industry, small chemical molecule chains are produced synthetically, whereas in the biotechnology industry, cell structures are larger and the molecule chains are longer and more sensitive. When conveying media by pumping it between containers, these molecules must withstand high shear forces. By analysing fluid dynamics and adjusting the internal geometry in M-blocks, shear forces can be reduced and molecules protected.
Formulation and filling are the final and crucial steps in the biotechnological and pharmaceutical production of active substances. During the formulation phase, the purified active substance is combined with suitable auxiliary materials, buffers and stabilisers to ensure optimum stability, effectiveness and service life of the medium. This is followed by aseptic filling under strictly controlled GMP conditions, during which the sterile product is transferred to vials, syringes or bags and sealed. This process guarantees sterility, dosing accuracy and product reliability.
When filling liquid or viscous cosmetic and pharmaceutical products, aseptic or hygienic conditions, high switching cycles and a high output volume are crucial. Filling needle and filling pipe systems ensure precise, splash-free and drip-free filling, even with demanding media. The use of modern plug diaphragm (PD) technology enables fast switching operations and ensures hermetic separation between the actuator and the medium – for maximum process reliability and product purity.
The requirements relating to linear filling are increasing, particularly for high value or sensitive products where filling accuracy and reproducibility are key. Modern filling systems enable fast and low-loss filling of containers, while the CIP- and SIP-compatible plant design ensures consistently hygienic or aseptic process control. This ensures contamination-free, efficient and reproducible filling that meets the highest quality standards in pharmaceutical and cosmetics production.
Sterilization is an integral part of pharmaceutical and biotechnological production and provides microbiological protection for products, media and plants. It is used in upstream (media, reactors) and downstream processes, from purification and filtration to aseptic formulation and filling, to ensure product safety, sterility and aseptic process control throughout. With increasing product complexity, stricter regulatory requirements and personalized medicine, the requirements placed on sterilization processes are constantly rising. The key challenge remains ensuring an optimal balance between sterility, product protection and sustainability.
In pharmaceutical and biotechnological production, sealed and temperature-resistant containers, such as ampoules or vials, are sterilized by cascading hot water over them. Short batch times, high circulation rates, high cascade density and fast heating times ensure uniform sterilization, guarantee reliable product quality and enable an efficient process sequence.
Integrity testing of sterile filters in accordance with FDA and GMP guidelines ensures that filters are fully functional before and after each production cycle and that the sterility of the product is guaranteed at all times. Methods such as bubble point tests, diffusion tests and water intrusion tests reliably check the filters for leaks and performance.
Compact stainless steel multi-port valve blocks combine filters, valves, fittings and connections in a single module, reducing space requirements and weld seams. They minimize internal volume, thereby increasing product output and process efficiency. At the same time, they enable simple and secure implementation of PUPSIT integrity tests directly in the production process. This efficiently ensures product quality and aseptic process reliability.
Auxiliary and supply processes – such as sterilization of media and plants, temperature control, CIP/SIP systems and media and gas supply – require reliable, customized valve designs to support the main process efficiently and safely.
The sterility of tools and components is essential for safe production processes in the pharmaceutical and biotechnology industries. Steam sterilization ensures aseptic conditions, whereby valves must meet requirements for steam, temperature and pressure resistance as well as a long service life, depending on the area of application, in order to ensure continuous process reliability and product protection.
In batch processes, temperature control directly influences product quality and process stability. Depending on the manufacturing method, container temperature control can be implemented directly or indirectly. Modern valve designs and control systems ensure reliable temperature control, support supply and auxiliary processes, and contribute to consistent product quality and safe process conditions.
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