Single-Use Systems: What You Should Know, Part 1

Single-use systems

The benefits for the pharma and biotech industries

by Eric Rentsch, Product Marketing Manager, Fluid Handling

Are you thinking of implementing single-use systems into your pharma or biopharma process but not sure it’s the right thing to do for the environment? Maybe you’ve heard about or are a part of the movement to eliminate plastic drinking straw for durable steel straws in hopes to save the planet and oceans from slow scourge of poor biodegradability. Many in the pharma and biotech industries have been doing the opposite for the very same effect—replacing reusable stainless steel fixtures with ready-to-use and disposable plastics in their process components and assemblies. This type of product is generally referred to as single-use which is somewhat of a misnomer. It can be used multiple times if one were so inclined, but the intended purpose is to be used and subsequently disposed of. The main benefits of these systems are two-fold: reducing the cost of equipment sterilization and boosting process flexibility all while reducing overall environmental impact.

No more expensive sterilization process

Proper equipment sterilization is expensive. Wetted components in the system must be cleaned and validated between batches. This contributes to the overall downtime, labor and risk of contamination to the product. Additionally, the amount of money demanded to purchase the cleaning equipment is not insignificant and neither is the energy needed to create the steam used in the process. Single-use systems are sterilized prior to integration usually by gamma irradiation. Some manufacturers will offer presterilized components, but some facilities employ different standards and will perform their own sterilization. Presterilizing the components eliminates the cleansing cycle and ensures no residuals providing a safer subsequent batch.

The flexibility of single-use systems

Another benefit of single-use systems is the flexibility they offer. Since the late 1990’s when single-use systems started trending, the variety of available equipment has expanded, almost redefining what a consumable should be. Starting with common consumables such as tubing and fittings, manufacturers are now offering single-use pH probes, UV, and turbine flow meters such as the Masterflex® Single-Use Flow Tube Sensors. Prior to these advancements, sensors were permanent fixtures that required repeated reintegration into the fluid path after each sterilization cycle, risking exposure and contamination. In addition, many manufacturers offer custom-designed assemblies outfitted with the latest technology to meet the requirements of today’s biologics as well as offering validation guides to their product’s purity and sterility.

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