Top 5 Challenges in Single-Use System Design

In the world of bioprocessing and biopharma, single-use systems have become essential due to their flexibility, scalability, and ease of use. However, with this reliance on single-use systems come several design and implementation challenges. Manufacturers often face hurdles like inefficiency, lack of standardization, complex procurement processes, and the need for stringent quality control. The Forge by Vulcan Bioworks addresses these issues head-on, providing a specialized tool to streamline single-use system design and ensure that each system meets high standards of compatibility, compliance, and efficiency. Here’s a closer look at the top five challenges in single-use system design and how The Forge solves each one.

Challenge 1: Inefficiency in the Design Process

Single-use systems are essential to bioprocessing, but designing them efficiently can be a challenge. Traditional design processes often involve switching between various tools, manually cross-checking standards, and troubleshooting compatibility issues among components. These steps can slow down workflows and result in time-consuming rework.

How The Forge Solves This
The Forge streamlines the design process with an all-in-one platform that integrates design, verification, and procurement. Its intuitive interface allows users to configure their systems quickly while benefiting from automated checks that flag potential issues early on. By eliminating redundant steps and consolidating design tasks in one place, The Forge accelerates project timelines and allows teams to focus on innovation rather than troubleshooting.

Challenge 2: Lack of Standardization Across Systems

Standardization is essential for ensuring compatibility and ease of scale in single-use systems. However, many companies struggle with inconsistent designs across projects, departments, or suppliers, which can lead to complications in component selection, regulatory compliance, and system integration.

How The Forge Solves This
The Forge employs a neutral taxonomy that promotes standardization across components, making it easy to select parts that work seamlessly together, regardless of the supplier. This vendor-neutral framework allows users to build designs that remain consistent across projects while retaining flexibility in component choice. With The Forge, companies can establish a standardized approach that supports long-term growth and reduces the complexity of scaling single-use systems.

Challenge 3: Complex Procurement and Supply Chain Management

Once a system design is complete, the procurement process can add another layer of complexity. Often, users need to source parts from multiple vendors, compare specifications, and ensure each component aligns with quality and compliance standards. This multi-step process can slow down the overall timeline and add unnecessary hurdles to project execution.

How The Forge Solves This
The Forge simplifies procurement with integrated e-commerce functionality, allowing users to move directly from design to purchase in a seamless, connected workflow. This feature enables immediate access to verified, compatible components from a range of suppliers, reducing delays and streamlining the process. By integrating design and procurement, The Forge eliminates bottlenecks, improves supply chain efficiency, and ensures users have the right parts available when they need them.

Challenge 4: Ensuring Quality and Compliance

Bioprocessing and biopharma are highly regulated fields where every component in a single-use system must meet strict quality and compliance standards. Ensuring compliance manually can be both time-consuming and prone to errors, which can lead to costly rework or, in worst cases, non-compliance issues that disrupt operations.

How The Forge Solves This
The Forge’s rules-based verification system checks each component in real time against regulatory and quality standards, ensuring compliance is maintained throughout the design process. With this feature, users receive instant feedback on component compatibility, reducing the risk of errors and eliminating the need for extensive post-design corrections. This functionality allows companies to confidently meet regulatory requirements without dedicating excessive resources to quality checks, saving both time and money.

Challenge 5: Difficulty in Scaling and Reusing Designs

In bioprocessing, the ability to reuse and scale validated designs is key to operational efficiency. However, many companies find it challenging to create adaptable designs that can be reused across different projects or scaled as demand grows. The lack of a centralized, standardized design library can lead to redundant work and inconsistent results.

How The Forge Solves This
The Forge promotes design reuse and scalability by allowing users to save, standardize, and adapt validated configurations. With a centralized library of reusable designs, teams can quickly pull from previously successful configurations, making it easier to adapt them to new projects or larger production scales. This capability reduces redundant design work, accelerates project timelines, and ensures that high-quality, compliant designs are readily available for future use.

The Forge as a Comprehensive Solution

Designing single-use systems doesn’t have to be a complex, disjointed process. The Forge offers a comprehensive solution to the top challenges in single-use system design by streamlining workflows, promoting standardization, simplifying procurement, and ensuring compliance at every step. By addressing inefficiency, lack of standardization, complex procurement, quality assurance, and scalability, The Forge empowers bioprocessing and biopharma teams to create reliable, efficient, and adaptable systems that meet today’s industry demands.

For teams facing daily challenges in single-use system design, The Forge provides the tools needed to work faster, smarter, and with confidence. Whether scaling production, maintaining compliance, or reducing project timelines, The Forge is designed to support the needs of modern biomanufacturers and help them succeed in an ever-evolving industry landscape.