The traditional image of production in the pharmaceutical sector is of a multitude of stainless steel pipes, tanks and reactors. And although steel is still very present today, the appearance of new medicines that are not produced in large enough quantities has led to a rethinking of the traditional model.
For certain processes (especially biological ones) it is easier and more economical to produce using single-use equipment. Single-use equipment is generally made of plastic, sterilized by gamma radiation, and is intended to be used only once (or only for a batch) and then discarded.
These systems offer a series of advantages that make them ideal for certain processes. The main points in favor of opting for single use technology are:
- Avoid cleaning and sterilization, and validation of these two procedures. This represents a reduction in the expenses associated with these steps (energy, steam, water…), as well as a significant saving in time.
- Being single-use equipment, these are smaller and give room for maneuver to produce more or less depending on demand. This can also translate into optimization of production costs.
- Initial investment. It is estimated that the initial investment for a production line is around 40% lower if this type of equipment is used.
- More sterility and lower risk of cross contamination. Using single-use equipment greatly reduces the probability of having to reject a batch because it has been contaminated.
- Lower risk of exposure for operators. In the production of medications with high toxicity, the process of manual washing of equipment that has been in contact with the product exposes workers to a risk that can be avoided if there is no this sanitation stage.
Practically, all the equipment involved in a production process can be single use: tanks, reactors, membranes, chromatographs, etc. It is even possible to combine stages with traditional equipment and others with single-use equipment within the same process.
But there are not all advantages in single-use components made with thermoplastic materials. Among its negative points, one of the most notable is that the recycling process of these materials is still not entirely possible. In an increasingly global world and where the use of plastics is unsustainably high, we find ourselves with a dilemma:
“More energy and material consumption (steam, stainless steel manufacturing process,…) in traditional stainless steel processes and facilities, or using single-use thermoplastics, which generates a large amount of non-recyclable waste (at least for the moment).”
It is not an easy question to assess, since we must take into account the different impacts in each environmental category that each of the solutions has. It would be wrong to put all the attention on just one type of impact, such as the generation of plastic waste. And in the end, the answer is going to depend entirely on the specific process being addressed.
Deciding between using traditional or single use equipment requires an in-depth analysis of the process and each of its steps. Assess the advantages and disadvantages to end up making the most viable decision.
If you are interested in learning more about single use equipment and how we can help you, contact us.
