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Single use equipment in pharmaceutical processes

Single use equipment in pharmaceutical processes

The traditional image of production in the pharmaceutical industry is a multitude of stainless steel pipes, tanks and reactors. And although steel is still very present today, the appearance of new drugs 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 cheaper to produce using single use equipment. Single use kits are generally made of plastic, gamma-sterilized, and are intended to be used only once (or only for one batch) and then discarded.

These systems offer a series of advantages that make them ideal for certain processes. The main factors why choosing single use technology is a good option are:

  • Avoid cleaning and sterilization, and validation of these two procedures. This means a reduction in the costs associated with these steps (energy, steam, water …), in addition to significant time savings.
  • Single-use equipment is smaller and gives room for maneuver to produce more or less depending on demand. This can lead to an 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 reduces the probability of having to reject a batch because of contamination.
  • Lower risk of exposure for operators. In the production of highly toxic drugs, the manual washing process of equipment that has been in contact with the product exposes workers to a risk that can be avoided if there is no sanitation stage.

Almost all the equipment involved in a production process can be single use: tanks, reactors, membranes, chromatography, etc. It is even possible to combine stages with traditional equipment and others with single use equipment within the same process.

Deciding between using traditional equipment or single use requires a thorough analysis of the process and each of its steps. Assess the advantages and disadvantages to end up making the most viable decision.

But they are not all advantages in single use components made of thermoplastic materials. Among its negative points, one of the most outstanding is that the recycling process for these materials is still not entirely possible. In an increasingly global world, where the use of plastics is unsustainably high, we are faced 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 it is necessary to take into account the different impacts in each environmental category that each solution has. It would be wrong to focus all attention on just one type of impact, such as the generation of plastic waste. And in the end, the answer will depend entirely on the specific process that is being treated.

If you are interested in learning more about single use equipment and how we can help you, contact us: klinea@klinea.es

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