Fluid management solutions for vaccine manufacturers

In vaccine manufacturing, the precision and efficacy of fluid management dictate the success and reliability of the entire production process. The challenges involved in handling fluids, be it in transferring, storing, or ensuring sterility, hold paramount importance. Addressing these aspects effectively not only impacts the potency and safety of vaccines but also significantly influences the efficiency and cost-effectiveness of production.

In the course of this article, we will discuss the manifold challenges in fluid management in vaccine production. We will discuss the differences between multi- and single-use solutions and illustrate the benefits of single-use fluid management solutions for vaccine manufacturers.

Why bother with fluid management in vaccine manufacturing?

Fluid management plays an integral role throughout the entire process of vaccine manufacturing. From the very outset, when raw materials are processed and combined to form the vaccine components, to the crucial stages within bioreactors, where cells grow and produce recombinant genetic material for mRNA vaccines, managing fluids accurately is essential.

Moreover, during filtration and purification, the meticulous transfer of fluids becomes important in eliminating impurities and preserving vaccine purity. Finally, when vaccines are filled into bioprocess containers, precise fluid management ensures accurate dosage and upholds sterility.

Challenges regarding fluid transfer in vaccine production

Fluid transfer in vaccine production is a meticulous process, demanding precision in dosage of biologics. It is challenging to ensure aseptic conditions to prevent contamination, e.g. when transferring fluids between bioreactors and different production phases.

Dealing with various product specifications, such as viscosities and material sensitivities, amplifies these challenges, requiring nuanced handling and careful monitoring throughout the liquid transfer process. The demand for accuracy and sterility in these transfers is critical for the final vaccine's safety and efficacy.

Multi-use or single-use solutions – what’s the better option?

Choosing between multi-use and single-use solutions in vaccine manufacturing involves weighing various factors like costs, efficiency, and contamination risks. Multi-use systems have historically been preferred for their cost-effectiveness and durability. However, they demand stringent cleaning and validation processes to ensure sterility between production runs, which are time-consuming and resource-intensive. Additionally, open handling of drug products is involved – another critical aspect of many multi-use systems.

Single-use solutions, on the other hand, enable fluid transfers in aseptically closed systems offering enhanced sterility, reducing the risk of cross-contamination without cleaning validations. They provide greater flexibility, quicker turnaround times, and reduced operational complexities.

Although the switch to single-use systems can be more expensive initially, they often result in overall cost savings due to reduced labor, maintenance expenses, and reduced product loss. Therefore, there is a notable shift in vaccine manufacturing towards single-use technologies.

Read more: Single-use technology & the implementation in biopharma

Single-use consumables for safe and efficient vaccine manufacturing

Single-use consumables can improve vaccine manufacturing by mitigating contamination risks. Their disposable nature eliminates cleaning and sterilization processes, preventing residue buildup or inadequate sterilization that might compromise the next batch.

At the same time, they minimize resource consumption and, thus, costs, while enhancing sustainability in the pharmaceutical industry. They ensure consistent sterility, critical for vaccine safety; also, reduced validation processes for single-use systems significantly lower downtime, further optimizing production.

IRIS single-use bioprocess containers and RoSS® Shell, secondary packagings, are meticulously designed to enhance protection and customization for vaccine products, protecting their contents from external factors. Their compatibility and adaptability in various configurations boost operational flexibility.

Automated fluid management with RoSS.FILL

RoSS.FILL revolutionizes vaccine manufacturing with its automated, single-use aseptic filling and filtration. Its exceptional speed, with the capability to fill one batch with up to 1000 L, ensures swift production, reducing time and resource investment. The fully disposable system guarantees absolute sterility, vital in vaccine manufacturing.

RoSS.FILL's scalability and adaptability accommodate various volumes, enhancing efficiency and minimizing product loss. Its integration of supplier-independent filters optimizes processes, making it a game-changer in vaccine production.

Enhanced consistency

Single Use Support’s fluid management solutions significantly enhance consistency in vaccine manufacturing through its automated precision. This system meticulously regulates volume, flow rates, and aseptic conditions, ensuring consistent, high-quality batches in single-use bags and bottles.

By eradicating human error and maintaining stringent controls, it minimizes variability across production cycles, thus fortifying the integrity and reliability of the final vaccine product. This level of consistency is of utmost importance in adhering to regulatory standards and ensuring the efficacy and safety of vaccines.

Improved resource efficiency

The automated dispensing system RoSS.FILL improves resource efficiency in vaccine manufacturing by eliminating the need for cleaning, a pivotal shift that conserves valuable resources. The system's design foresees single-use consumables and therefore eradicates the labor-intensive and resource-draining processes associated with cleaning and sterilizing traditional equipment between batches. This can reduce water usage and energy consumption, lowering the environmental impact of manufacturing processes.¹

Moreover, the elimination of cleaning steps spares human resources, redirecting skilled labor to more critical tasks, thereby amplifying productivity. This streamlined approach not only boosts efficiency but also reduces operational costs substantially. Additionally, designing standardized, automated processes can reduce the contamination risk of precious drug products or their respective components, further optimizing resource effectiveness.

Especially when producing vast amounts of vaccines, product loss and ineffective manufacturing can pose a huge threat for vaccine manufacturing companies and the accessibility of their products. The measles vaccine, for instance, comes with a cost of less than 1 US-Dollar per child. And with a WHO recommendation for every child to be vaccinated, it is important to provide worldwide access at reasonable cost.²

To cut a long story short: RoSS.FILL aligns with modern sustainability objectives, offering a more eco-friendly solution while being cost-effective for manufacturers. By reducing waste, conserving resources, and optimizing manpower, the system redefines the paradigm of resource management in vaccine production.^1 2 

cGMP compliance

cGMP (current Good Manufacturing Practice) compliance is paramount in vaccine production, and RoSS.FILL is tailored to uphold these rigorous standards. The system's design aligns seamlessly with cGMP guidelines, incorporating automated controls and pre-sterilized single-use components. It ensures a closed, aseptic environment, eliminating contamination risks and guaranteeing the integrity of the produced vaccines.

RoSS.FILL's adherence to cGMP regulations offers reliability to manufacturers, assuring them of consistent, high-quality production and compliance with the strictest industry standards for pharmaceutical manufacturing.

Learn more: Meeting cGMP regulations with innovative single-use technologies | cGMP in vaccine manufacturing

Reduced need for manual intervention

RoSS.FILL significantly minimizes the reliance on manual intervention within vaccine manufacturing, resulting in cost savings, error reduction, and decreased contamination risks.

The system's automation drastically diminishes the need for human involvement, lowering labor costs and substantially mitigating potential errors or contamination risks associated with manual handling. Its closed-loop, automated operation ensures a sterile environment, minimizing exposure to external impurities throughout the production cycle.

By reducing manual intervention, the modular filling system not only enhances operational efficiency but also bolsters safety measures, guaranteeing a more reliable and error-resistant vaccine manufacturing process.

Read more: Reducing human errors and technology failures in biopharma

Advanced fluid management solutions by Single Use Support

Advanced fluid management solutions by Single Use Support represent a transformative leap in modern bioprocessing. Leveraging cutting-edge technology, Single Use Support has engineered a suite of state-of-the-art systems, including RoSS.FILL, RoSS.PADL, RoSS® Shell, and IRIS single-use bioprocess containers, each designed to optimize different facets of fluid management in the manufacturing pipeline.

These advanced solutions cater to the evolving demands of the biopharmaceutical industry, addressing critical challenges in vaccine manufacturing such as sterility assurance, scalability, cost-effectiveness, and sustainability. The range of products ensures a comprehensive approach to fluid handling, ensuring efficiency, flexibility, and adherence to stringent quality standards.

These solutions underscore Single Use Support's commitment to advancing fluid management solutions and its dedication to empowering vaccine manufacturers with highly efficient, scalable, and innovative systems. These enable them to streamline processes, enhance productivity, and meet the evolving needs of the industry.