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Radar Level Measurement Discover the Advantages of 80 GHz Radar Sensors for Single-Use Applications

| Author / Editor: Claudia Homburg* / Dr. Jörg Kempf

Single-use systems are gaining ground in the upstream and downstream processing of biopharmaceutical production. One of their strengths is flexibility — but at the same time it is a challenge for measurement technology. For example, level measurement must be as flexible and efficient as the entire single-use equipment.

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Simply from outside through the bag: the 80 GHz radar level measurement makes it possible.
Simply from outside through the bag: the 80 GHz radar level measurement makes it possible.
(Source: ©Pavlo Kucherov; ©srckomkrit - stock.adobe.com; [M]-Herkersdorf)

In the biopharmaceutical industry, single-use technology is one of the answers to the demand for more agile manufacturing processes that also meet regulatory challenges. It enables fast, seamless product changes while maintaining hygiene and optimizing process costs.

In single-use production of active agents and biopharmaceutical products, the entire process chain consists of sterile, disposable systems. The method thus perfectly meets the increasing demands on the productivity, cleanability and flexibility of production systems. Single-use equipment offers a number of advantages in biotechnological processes as well as in sterile drug manufacturing.

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Did you know that ...

... biopharmaceutical products now account for more than 15 percent of the total pharmaceutical market as well as 50 of the world's most important drugs. Every third new drug approved by the FDA is produced via biotechnological means; in immunology, one of every two new drugs is a so-called “New Biological Entity” (NBE). The large number of products currently under development proves that this is not just a temporary phenomenon.

Compared to stainless steel systems, the costs for cleaning are greatly reduced, as is the work involved in cleaning validation. The elimination of CIP and SIP cleaning also saves valuable production space. Single-use processes can improve time-to-market by eliminating system setup work and enabling faster scale-up. In short: this technology allows flexible production and a correspondingly flexible response to market demands.

Increased Acceptance by Authorities

The increasing application of single-use is increasing specialist know-how: the requirements this production method has to meet are being better and better understood. Acceptance by authorities and customers is also increasing. In view of the above-mentioned advantages, the method is virtually predestined for use in the manufacturing of highly active products. This is because containment and docking between insulators and pressure vessels play a central role here. In fact, the interfaces between process and containment are particularly critical areas. But in single-use applications, this problem is easily solved: a new, sterile surface is used for each batch — completely eliminating the risk of cross-contamination.

The Role of Sensors in Single-Use Production

Biopharmaceutical products do not fall into the category “simple”, because the list of challenges for manufacturers is long. All large, as well as small, problems can only be successfully solved if the right components are used. This also applies to the sensors that monitor level and pressure during the manufacturing process, ensuring quality and reproducibility.

A single-use reactor is usually delivered pre-sterilized, cannot be opened afterwards and must be completely disposed of at the end of the process. While single-use systems are becoming more and more sophisticated as they are used more often, there is still no consensus on which sensor technology is the best for them — indeed it remains a much-discussed topic. Although invasive measuring systems, whether in the form of built-in components or inserted probes or sensors, are totally out of the question, continuous level detection is still necessary to ensure high process efficiency.

What has to be considered? Basically, the requirements on the sensor technology here differ only slightly from those in conventional pharmaceutical applications. As in all other parts of the process, the focus is on cleanability and sterility. However, the requirements are extended to include higher sensitivity, optimized response behaviour and narrow tolerance ranges. In addition, sensors in a single-use system have to be mechanically robust and operate with as little calibration as possible.

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Any product contact that can be avoided increases compliance with production according to GMP. It reduces the risk of contamination of the product through cross-contamination or the abrasion of particles from contacted materials — and makes it easier to validate the safety and reliability of the system.

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