Written by Armin Scheuermann
Single-use technology has been an important trend in pharmaceutical and biopharmaceutical manufacturing for about 20 years. The main reason for this is to avoid cross-contamination. When stainless steel equipment is used, these components have to be thoroughly cleaned, dried and validated after each use before they can be used for the next product. This is a very laborious process that can be avoided by using single-use equipment.
Yes, single-use technology is often associated with a throwaway mentality, which does not fit into today's world. For this reason, we have conducted studies, including one in collaboration with a well-known Swiss pharmaceutical company. The results show that single-use technology actually causes only half the environmental impact compared to stainless steel equipment. This is mainly because enormous amounts of energy and resources are consumed in the cleaning and drying of stainless steel components. In use, single-use technology is therefore twice as clean.
The biggest advantages of closed systems are simplified handling and the ability to maintain the cleanroom class at a lower level. In this case, closed systems are often not required because the product is hazardous, but because the cleanroom class is to be maintained at a lower level in the ballroom concept – and that really saves operating costs. Our solution makes it possible to close the last open hole in the process – the interface for material input. This minimises the introduction of impurities. We can ensure the closed environment through a secondary enclosure and easy handling, which is currently of the utmost importance in biotechnology.
In general, the aim is to further simplify product handling – and to achieve this, manufacturers of biopharmaceutical products are looking for closed systems that make this possible. This applies particularly to the introduction of substances via interfaces. In this context, containment is not only important to protect operators, but also to keep the cleanroom class in production low. Our specially developed connector allows a secure and closed connection to be established in a single step, meeting the latest requirements in biotechnology.
