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Enhancing Process Flexibilitywith Automated Filling

During the production and filling of highly complex biopharmaceuticals in cell and gene therapy, precise flow measurement and accurate air bubble detection play a crucial role. Flow meters and air bubble detectors ensure consistently high product quality to provide patients with effective and safe drugs. Using the example of the RoSS. FILL platform, developed by the Austrian company Single Use Support, ultrasound specialist SONOTEC explains how non-contact clamp-on flow meters and air bubble detectors can significantly increase the accuracy of automatic filling.

Challenges in Aseptic Filling

Accurate and efficient filling of biopharmaceuticals in single-use bags, bottles, or vials is crucial. Even the smallest deviations in the filling volume can have a huge impact on the production process, or finally on the patient‘s therapy.

For example, if a liquid needs to be frozen for transport, overfilling or an inconsistent volume of single-use bags seriously increases the risk of bag leakage and product loss. In most cases, it is absolutely important that a patient receives exactly the same volume of medication per injection.

Operational errors in aliquotation processes often occur due to manual intervention or limitations. The major challenges in aseptic filling are:

• Accuracy

• Consistency

• Flexibility

• Scalability

By implementing automated filling solutions with leading flow measurement technology, product and material loss, human errors, as well as the risk of contamination can be significantly reduced, while process flexibility can be substantially increased.

Solution Provider: Single-Use Support

Innovative automated fluid management solutions provided by the company Single Use Support set a new standard in biopharmaceutical manufacturing.

The company offers specific expertise and fast solutions in processes regarding cell and gene therapies (CGT) but also commercial bulk drug substance handling and vaccine manufacturing transfers, and drug productions. With its expertise and advanced bioprocessing solutions, Single Use Support has become the market leader in the accurate filling of very small volumes in single-use bags.

Highest Accuracy for Better Operator‘s Control

With its fill & filtration platform RoSS.FILL, Single Use Support offers unlimited scalability for aseptic filling from laboratory to commercial production. The modular platform is designed for filling multiple smaller and larger volumes between 1 mL and 1000 L into single-use bags or bioprocessing containers.

For low-volume dispensing at a commercial scale, accuracy and repeatability are essential. To achieve a filling accuracy range of even less than ± 1 mL with the RoSS.FILL platform, Single Use Support decided to implement SONOTEC‘s SONOFLOW CO.55 V3.0 ultrasonic flow meters. The sensors are easily clamped on the tubing and measured without any contact and therefore without any risk of contamination or leakage.

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