As the word suggests, single-use technology is disposable equipment for your process steps – and thus an excellent alternative to the heavy and sterilization-dependent facilities that are normally known in the industry. The single-use technology is a technology within the industry that increasingly becomes part of the entire process, precisely because it brings a lot of advantages with it that both make companies competitive, time-saving and not least cost-optimized. This article will review 4 comprehensive reasons for choosing single-use products in your process steps in the pharmaceutical industry.
4 reasons to choose single-use products
1) Production costs will decrease
Traditionally, clinical processes are highly associated with cost-intensive processes, right from the development of the product to the final release. The high production costs are primarily due to the necessary cleaning (CIP) and sterilization (SIP) of the production facilities, which is an essential and all-important part in relation to achieving the desired result for the final product.
One of the most significant advantages of replacing the stainless steel systems with the single-use technology is precisely that production costs will fall because cleaning and sterilization are not necessary with disposable equipment. Labor costs in connection with setting up and maintaining the steel plants are also reduced.
Many companies will also find that there will be a reduction in investment and R&D costs, as most parts of the clinical processes will be cost-reduced with the single-use technology.
2) Productivity will increase
If you use traditional steel plants in the process, as described above, you will be forced to use a lot of resources to clean and sterilize. Not only is it expensive, it is also a time burden for the entire process, which can drag on for a long time when you have to scale up from laboratory scale to pilot plant and beyond. With the single-use systems, it becomes much easier to scale up, and at the same time productivity is increased as precious time is not spent on cleaning and sterilisation. When you use single-use technology, time is also saved on set-up, installation and any repairs that you otherwise have to do on the well-known steel reactors. Here productivity is also increased. Validation and documentation is also a step that becomes redundant when using the single-use technology – in other words, the process becomes faster and more flexible all the way around.
3) Reduction of risk of contamination
The risk of aseptic or cross-contamination is one of the biggest challenges in the industry, as it can lead to product discard, which is both time-consuming and costly. The risk of cross-contamination is particularly high if different proteins or antibodies are processed in the same facilities.
With the single-use technology, this risk will be significantly reduced as cross-contamination becomes almost impossible with disposable equipment. Single-use is therefore worth considering in processes where avoiding cross-contamination is the highest priority.
4) Environmental benefits
You would basically almost think that disposable equipment would be an environmental hog – especially because most disposable equipment is made of plastic. But if you start from the fact that the stainless steel reactors must be cleaned, cleaned and sterilized with large amounts of water and harmful chemicals combined with a large energy consumption, then single-use systems are worth preferring.
However, the fact that most single-use equipment is made of plastic also has its disadvantages. Plastic also emits some substances that can be harmful to your production – therefore it is important to think things over before jumping into the single-use trend!
We have more than 20 years of experience with qualification, validation and quality assurance in the pharmaceutical industry.
The single-use trend is a trend that is here to stay – and that is why we at AL Engineering are ready to help with whatever challenges it may present. We can e.g. help qualify and validate (read more here) as well as support with quality assurance within pharma (read more here).