Single-Use Technologies: Why Disposable Systems are Winning in Production
Last updated: 27. March 2026
Single-use technologies (SUT) refer to disposable systems in which the equipment parts coming into contact with the product are used only once. The decisive advantage: after use, the components are disposed of, completely eliminating complex cleaning and sterilization processes (CIP/SIP) as well as their time-consuming validation to avoid cross-contamination. This minimizes the risk of product carryover and increases safety, especially in multi-product manufacturing.
The counterpart to single-use technology is the classic reusable system made of stainless steel. Here, the equipment must be cleaned and sterilized after every cycle according to the strictest rules. But that's not all: the success of this process must be proven through seamless validation before the system is ready for the next use again. SUT breaks this rigid cycle and ensures significantly more agility in day-to-day production.
What types of single-use technologies are there?
- Bags: These aseptic disposable plastic packages are ideal for the safe handling of liquids. However, they also demonstrate their strengths with solids such as granules or powders, as they safeguard material quality over the long term.
- Containment Systems: In addition to bags, specialized SUT solutions for containment are standard today. With the FLECOTEC system, Rommelag offers a highly specialized solution for the dust-free, closed transfer of highly potent substances (up to OEB 5). The system utilizes high-performance pharmaceutical films with integrated ZIP components, which are connected via a special slider to create a high-density seal. This mechanism enables a secure, validatable interface and provides seamless protection for both people and products.
- Connectors: For the process chain to function, bags and tubes must mesh seamlessly. Sterile connectors or tube welding processes create these secure connections.
- Filters & Sensors: Single-use filters serve for sterile filtration, while disposable sensors can be directly integrated to keep an eye on critical parameters such as oxygen content or temperature at all times.
What is behind "Plug & Produce"?
In professional circles, the term "Plug & Produce"—meaning "plug in and get started"—is often mentioned. This aptly describes the core of the technology: the manufacturer connects the standardized modules and can start production immediately. Since the components are delivered already sterile, the effort for equipment qualification is massively reduced compared to permanently installed stainless steel systems.
Stainless Steel and Single-Use in Direct Comparison
Stainless Steel
For a long time, stainless steel systems were the gold standard. They are extremely stable and ideal for very large production volumes. Furthermore, their waste balance appears better at first glance. However, the downside is the enormous effort: the system must undergo lengthy preparation between batches. This costs time and reduces productivity, as the plant stands idle during cleaning.
Single-Use
Today, the pharmaceutical, chemical, and cosmetics industries primarily rely on disposable solutions. Since the components are disposed of after use, the risk of cross-contamination can be reduced to a minimum by design. Where stainless steel requires complex cleaning validation, SUT systems enable more flexible product changes and a shorter time-to-market.
Important to know: A central aspect of plastics is so-called Extractables & Leachables (E&L)—substances that could migrate from the material into the product. Therefore, the use of qualified materials is mandatory, which are classified as USP Class VI compliant and have been validated through detailed E&L studies as well as compliance with Ph. Eur. (e.g., Chap. 3.1). For seamless compliance, product-contact surfaces must also be designed according to 21 CFR 211.65 so that they are not reactive or absorptive. Additionally, validated integrity tests (leak tests) ensure the barrier function of the overall system.
Ecological Responsibility
Naturally, the use of disposable components generates waste. This makes responsible process planning all the more important:
- Thermal recovery: Plastic waste can be used to generate electricity or heat.
- Recycling: The industry's goal is the material recycling of high-quality plastics after safe decontamination.
- Prudent use: SUT components are used specifically where they offer the highest level of safety—such as with frequent product changeovers or the handling of highly potent active ingredients (HPAPI). The goal always remains a highly efficient Contamination Control Strategy (CCS).