Flexible and versatile, precisely integrated
We develop reliable Single-Uuse solutions for biotechnological and pharmaceutical processes – quick to integrate, regulatory compliant and ideal for scalable production
The versatile way to increase flexibility and agility in plants while simultaneously minimizing risks is the implementation of Single-use technologies. The focus is on flexible, efficient solutions that companies can quickly and safely integrate into existing processes. In addition to cost efficiency, the quality of materials, the scalability of systems and compliance with regulatory requirements are particularly important.
Together with our customers, we develop customized solutions that are tailored to the requirements of modern production environments. We support you with technological expertise, reliable components and close communication to ensure that your processes remain safe, economical and future-proof.
Single-Use technologies are particularly suitable for overcoming time-to-market challenges, efficiently manufacturing small production volumes and preventing cross contamination in biotechnological and pharmaceutical processes.
Precise and stable process conditions are crucial for healthy cell growth in bioreactors.
Single-Use diaphragm valves enable reliable dosing and precise control of nutrient and buffer media – for reproducible results and consistent quality.
During scale-up, our pinch valves ensure controlled, turbulence-free flow. The gentle conditions protect the cells and enable an efficient transition to larger production stages.
In the downstream process, media and buffers are prepared, cells are harvested, filtered and treated chromatographically, virus inactivation and dosing are carried out, and the final product is separated from impurities in several isolation and purification steps and finally filled.
During partial harvesting and filtration, the focus is on the precise separation and transfer of process liquids. The media flows must be reliably monitored and the filtration cycles precisely controlled in order to avoid product loss.
With the Single-use diaphragm valves GEMÜ SUMONDO, these processes can be controlled safely and precisely. The design minimizes product loss, while the tried-and-tested diaphragm technology ensures consistently high tightness and sterility.
A consistent Single-use setup allows the Annex 1 requirement for PUPSIT (Pre-Use Post-Sterilization Integrity Testing) to be reliably implemented as a Single-use solution.
The precise preparation of buffers and media is crucial for consistent process conditions downstream. This involves the controlled mixing, distribution and provision of various liquids – under strict sterile conditions. Minimal dead space, low hold-up volumes and precise control of media conditions are essential.
GEMÜ Multiport SUMONDO enables space-saving, sterile and reproducible process control. With its integrated sensor system and standardized connection systems, complex piping systems can be clearly created and safely controlled.
© Sartorius AG
Controlled handling, dosing and filling are the focus of final product preparation. The media must be precisely controlled, monitored and documented under sterile conditions.
With pre-assembled GEMÜ Single-use flowpaths, you get fully validated systems that cover all process steps up to sterile filling. The integrated sensor system ensures continuous control of pressure, flow and temperature, while the modular design offers maximum flexibility in design and scaling – for reproducible, safe end processes in biopharmaceutical production.
Single-Use product range
With our products, you get reliable, safe and tried-and-tested solutions for Single-Use applications from a single source. Discover suitable components and systems for your plant here.
Tested quality
Precision, purity and quality
At our Emmen site, we manufacture, assemble, clean and pack products under cleanroom conditions according to ISO class 8 – including up to ISO class 6 on-site.
Production includes injection moulding, assembly technology, cleaning and packaging in a controlled environment in accordance with EN ISO 14644-1.
Our modern testing plants enable complete product validation. We manufacture in accordance with GMP guidelines, in compliance with ISO 9001 and TSE/BSE-compliant processes. The manufacturing site is registered with the FDA. Validated transport logistics according to ISTA and comprehensive access and contamination management ensure consistently high product quality.
We take great responsibility when developing, checking and approving every component, every document and every step. So you can rest assured that your process will run smoothly from development to approval.
The advantages for you
Hermetic separation of actuator and medium due to internal welded diaphragm. Enables Single-Use components to be changed quickly and easily between product cycles.
Delivery of complete plant sections that are qualified, documented and sterilized – regardless of whether they are standard, third-party or custom-designed components.
Unobstructed flow, avoidance of turbulence and reduction of cell damage through the use of GEMÜ pinch valves – for high yields
Minimization of the footprint within the plant by integrating several valve bodies and sensors into one multi-port valve block.
