Single–Use Technology and the Challenge of Automation
Single-use systems normally involve a significant amount of manual intervention. The level of automation on these systems is generally lower than on comparable conventional systems. The complete package used for a process step is often assembled from individual components. In some applications (e.g., when hazardous substances or organisms with high risk potential are involved), overall system integrity should be verified prior to deployment. “Most disposable systems are produced manually, and it is very difficult or impossible to verify integrity at the user site. The customer has no way of determining whether disposable systems have, for example, been damaged in the logistics chain or during handling on site. Problems of this nature could ultimately lead to leakage and contamination or effective loss of the product. Due to the potential losses involved, users may rule out disposable systems right from the start,” explained Jens Kubischik from Pall Life Sciences. He further added, “For that reason, it is absolutely essential to build up a supplier-user relationship that is based on trust – and is reinforced through production process transparency and verification audits.”
Disposal and Sorting of Single–Use Systems
Disposal is another important aspect of single-use technologies in biopharmaceutical production. Because these systems often contain composites, material separation and sorting become a major challenge. The list of materials involved includes metal parts and a variety of plastics.
All of the process steps in some applications are based on single-use systems, and when that is the case waste volumes can be quite considerable. The bags, tubes, filters etc., which accumulate may be contaminated with organisms and/or chemicals that pose an environmental hazard. These items require treatment prior to disposal. Waste plastic is normally incinerated or sometimes taken to a disposal site.
Waste Inactivation – Innovation Needed
Only a limited range of systems is currently available for shredding and compacting large volumes of waste. There are virtually no systems on the market for waste inactivation or decontamination. In addition to that, there is no way of locally separating and sorting composites for recycling. As a consequence, an elaborate and costly logistics system is needed, and that can offset the advantages of single-use technologies in process applications. This is a major issue that requires innovative solutions. Material flow strategies will need to be part of the overall plan right from the start. Other industries such as food processing, which face similar issues are currently addressing the problem, and it should be possible to adopt those solutions to the biotechnology sector.
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