Single-use manufacturing is the production of a finished product that is designed to be used once. In the biopharmaceutical industry, single-use manufacturing is an important and growing part of the industry.
Why utilize single-use manufacturing?
There are many advantages to single-use manufacturing in the biotech and biopharmaceutical industry. As the industry continues to grow, evolve and change, the processes used for their development are continuously updated. With each new R&D test, there is a slight change to the fluid used, or material compatibility changes. With all these changes, solutions designed for a single-use are more effective than their multi-use counterparts.
Benefits to single-use manufacturing
When a solution is manufactured for a one time use, it is designed for one application, allowing it to be tailored to the exact needs of said application. This leads to optimal performance for the desired bioprocess and could be the difference between a successful or failed trial. Additionally, single-use solutions can be supplied pre-sterilized, helping reduce downtime and accelerate process startup.
Cut down change-out times
At the end of a production run, the used single-use assembly can be safely removed and disposed of according to established facility waste-management procedures, eliminating the need for cleaning and validation and allowing you to quickly prepare for the next batch or process. With products built for multi-use, the products have to be disassembled, cleaned extensively with chemicals to ensure no contamination passes from one application to the next, and repurposed into the new bioprocess. Between the time to clean the products and the cost of chemicals, the single-use option becomes more advantageous for big pharma companies.
Greater flexibility
Single-use assemblies are created for the exact needs of a specific process. When purchasing multi-use equipment in comparison, it is critical to make sure the piece of equipment will work across multiple applications, sometimes sacrificing unique features of each individual application. Choosing to use single-use manufacturing means that assemblies can be a perfect fit every time, even if the process applications are changing monthly, weekly, or even daily.
Reduce contamination risks
When cleaning multi-use equipment, there is always a small chance that trace particles of the substance you are working with could be left behind in trace amounts due to human error or another mistake. By using single-use assemblies, the risk is removed that the next batch may be contaminated by the previous with single-use assemblies, which are typically constructed in a sterile environment and come in cleanroom ready packaging.