The selection of the right tubing solutions plays a pivotal role in maintaining product quality and process efficiency in pharmaceutical fluid management. Whether it is for transferring pharmaceutical liquids, conducting biopharmaceutical experiments, or other critical applications, the choice of tubing, and single-use assemblies, is far from trivial in biopharmaceutical fluid management.

Therefore, in this blog post, we will take a closer look at different considerations on tubing solutions for pharmaceutical liquids. It's important to note that this is a general article providing an initial glimpse into the world of pharmaceutical tubing solutions. We will explore their exciting fields of application and compare multi-use and single-use tubing systems, illustrating why Single Use Support believes that single-use solutions pave the way of success.

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Bioprocess tubing solutions

Tubing solutions in the field of biopharmaceuticals encompass a wide range of applications, each with its own set of unique challenges and requirements. In the following sections, we will illustrate them in more detail.

7 fields of application for liquid tubings

Tubing solutions in the field of biopharmaceuticals encompass a wide range of applications, each with its own set of unique challenges and requirements. In the following sections, we will illustrate them in more detail.

Liquid tubings are ubiquitous in biopharmaceutical manufacturing, but also in research and diagnostics. Here are 7 prominent examples:

Bioprocesses and cell culture: Tubing solutions are integral to the cultivation of mammalian cells for the production of biopharmaceuticals. They are used for media transfer to bioreactors, cell harvest, and product clarification. The success of these processes is heavily reliant on the tubing's material compatibility and integrity to maintain a sterile environment.
Chromatography and purification: In chromatography processes, tubing connects columns, detectors, and pumps. This application requires precision and high-purity tubings to prevent contamination and ensure accurate separation and purification of bioactive compounds.
Bulk drug substance transfer: For biopharmaceutical manufacturers, the safe and sterile transfer of bulk drug substances is of greatest importance. Tubing solutions play a vital role in transferring these valuable and sensitive materials from one processing step to another.
Fill and finish operations: Tubings are used for aseptic filling and sealing of vials, bags, and other containers. It must meet stringent requirements to prevent microbial contamination and maintain product sterility.
Diagnostics and biotechnology: Tubing solutions are employed in various diagnostic and biotechnology applications, such as DNA sequencing, PCR, and other analytical techniques, where precision, low dead volume, and high chemical resistance are crucial.
Vaccine production: Tubing solutions are critical in vaccine manufacturing processes, ensuring the integrity of the vaccine components and preventing any cross-contamination.
Clinical trials: Tubing solutions are used in clinical trials for investigational drug products. They must meet regulatory standards to ensure the safety and efficacy of the trial outcomes.

Regulatory Compliance

The biopharmaceutical industry operates within a highly regulated environment, and tubing solutions must conform to a myriad of standards and guidelines. Some prominent aspects in regulatory compliance include:

Good manufacturing practices (GMP): Tubing materials and manufacturing processes must comply with GMP standards to ensure product quality, safety, and efficacy
US Pharmacopeia (USP) (USP) standards: Tubing materials need to meet USP Class VI standards, which assess the biological safety of plastics used in medical devices and pharmaceutical applications.
ISO standards: The International Organization for Standardization (ISO) has developed various standards related to tubing solutions, such as ISO 10993 for biocompatibility and ISO 14644 for cleanrooms.
FDA regulations: The U.S. Food and Drug Administration (FDA) enforces regulations governing the use of tubing in pharmaceutical applications, particularly in the context of cGMP (current Good Manufacturing Practices) and aseptic processing.
European pharmacopoeia: In Europe, the European Pharmacopoeia sets standards for materials and processes used in pharmaceutical tubing to ensure product safety.
Bioprocessing standards: Organizations like BPSA (Biopro-Process Systems Alliance) have developed guidelines for single-use systems used in bioprocessing, including tubing solutions.

Multi-use or single-use tubings for pharmaceutical liquids?

When handling pharmaceutical liquids, the choice between multi-use and single-use tubing solutions holds the key to optimizing processes. Thus, the upcoming chapters will elucidate the critical aspects of these tubing options. We aim to provide you with the knowledge and insights necessary to determine the ideal tubing solution for your unique requirements.

Frequently used materials

Material selection in pharmaceutical tubing is significantly influenced by whether it is intended for multi-use or single-use applications. For multi-use systems, stainless steel and glass are preferred due to their durability and sterilizability. Stainless steel's corrosion resistance makes it ideal for long-term use, while glass's inert properties prevent interactions with pharmaceutical liquids.

Frequently used materials for multi-use tubings include:

Stainless Steel
Glass
PTFE
Polypropylene
PVCPEEK

In contrast, single-use tubings typically rely on flexible, disposable materials such as silicone and TPE (thermoplastic elastomers). These materials offer the necessary flexibility and biocompatibility while minimizing cross-contamination risks, eliminating the need for extensive cleaning and sterilization.

Materials for single-use tubings may be:

Silicone
TPE
Polyethylene
Polyurethane

Tubing flexibility and versatility

Flexibility is a defining characteristic that distinguishes single-use and multi-use tubings in the field of pharmaceutical applications, and this difference significantly influences their applicability for various purposes.

Multi-use tubings prioritize durability over extreme flexibility. They are designed to withstand repeated sterilization and cleaning cycles, which makes them a frequent choice for long-term applications. Materials like stainless steel or glass are often employed for their resilience in these situations. Multi-use tubings perform reliably in demanding environments, where extreme flexibility may not be the primary concern.

Single-use tubings, in contrast, are celebrated for their exceptional flexibility, making them highly versatile for a wide range of pharmaceutical applications. Their key advantages lie in their adaptability, as they readily conform to the unique requirements of each application, whether it involves bioreactor setups, chromatography columns, or aseptic filling processes. Furthermore, their flexibility minimizes residual volume, ensuring efficient pharmaceutical liquid transfer and reducing wastage – an especially important consideration when dealing with costly or limited-volume materials. Additionally, the pliability of single-use tubings simplifies their installation, leading to time and labor cost savings during the setup of pharmaceutical processes.

Cleaning and sterilization – what about sustainability?

The practice of cleaning and sterilizing tubings is not only essential for maintaining the integrity of pharmaceutical processes, but a considerable point of concern regarding sustainability. When comparing single-use and multi-use tubings, their impact on sustainability becomes a pivotal factor to consider.

Single-Use Tubings, due to their disposable nature, inherently offer certain sustainability advantages:¹¹

Reduced resource consumption: Single-use tubings eliminate the need for cleaning and sterilization, resulting in lower water and energy consumption, which is a significant step towards reducing the environmental footprint.
Minimized chemical usage: Cleaning processes often involve the use of chemicals, which can be reduced or completely eliminated with single-use tubings, lessening the environmental impact associated with chemical waste.
Lower risk of cross-contamination: Disposable tubings effectively eliminate the risk of cross-contamination, ensuring product safety and reducing the likelihood of costly batch losses.

Multi-use tubings, on the other hand, require thorough cleaning and sterilization, which can pose sustainability challenges:

Resource-intensive cleaning: Cleaning and sterilizing multi-use tubings demand substantial quantities of water, energy, and cleaning agents, contributing to increased resource consumption.
Chemical waste: The use of cleaning agents can result in chemical waste, necessitating careful management to minimize environmental impacts.
Cross-contamination concerns: Despite rigorous cleaning processes, multi-use tubings carry a risk of cross-contamination, potentially leading to costly batch losses, which may not align with sustainable practices.

Other components of single-use manifolds

Single-use manifolds are essential in pharmaceutical fluid management. They consist of various components for the fluid paths, such as connectors, valves, filters, pressure sensors, single-use beta bags and more. These components ensure the efficient and precise flow control of pharmaceutical fluids.

In addition to manifolds, several other non-sterile and sterile consumables are vital in pharmaceutical fluid management. These include sterile filters, caps, closures, tubing seals, clamps, sampling bags, tubing welders, sealers, mixing systems, and sterile adhesives and tapes. These consumables each play specific roles in maintaining the purity and sterility of pharmaceutical fluids, and are crucial for the safety and efficiency of pharmaceutical processes.

Bioprocessing tubing solutions by Single Use Support

Due to their numerous advantages in terms of flexibility, safety, sustainability and ease of use, Single Use Support has developed single-use consumables that accompany the single-use based fluid management systems.

At Single Use Support we develop and customize fluid path solutions for our clients. As an independent service provider we assemble everything according to the specific requirements of our customers. An integral component of those consumables are single-use tubings, improving process efficiency while minimizing the risk of contamination.

These disposable tubings are accompanied by a wide array of additional single-use consumables, from connectors, filters and distributors all the way down to disposable bioprocess containers.

IRIS Single-Use Assemblies

Tubing solutions for pharmaceutical liquids

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