In biopharmaceutical manufacturing, sterility, efficiency, and accuracy are critical for maintaining high product quality and regulatory compliance. One of the biggest challenges in vaccine production is achieving sterile and consistent sampling at multiple time points without compromising process integrity. Traditional sampling methods often require biological safety hoods, increasing complexity, time, and contamination risks.
To address these challenges, Avantor developed a customized, GMP-compliant, single-use solution: the OmniTop Sample Tubes® Manifold. This case study explores how this innovative closed system sampling solution simplified the process for a vaccine manufacturer, ensuring sterility and efficiency while providing flexibility in sample collection.
Challenges in Bioprocess Sampling
A vaccine manufacturer faced several key challenges in their bioprocess sampling workflow:
Sterility Assurance: Sampling needed to be performed in a completely closed manner to eliminate contamination risks, making biological safety hoods unnecessary.
Multiple Sampling Time Points: The system had to accommodate sampling at varying time intervals without disrupting the manufacturing process.
Different Sample Tube Materials and Volumes: The workflow required different tube materials and multiple sample volumes, necessitating a flexible yet standardized solution.
Process Efficiency: Traditional sampling techniques introduced inefficiencies, including prolonged handling times and increased operator workload.
To maintain regulatory compliance and sterility, the manufacturer required a novel approach that could integrate seamlessly into their existing workflow without compromising product integrity.
Avantor’s Innovative Closed System Solution
To meet these stringent requirements, Avantor designed, prototyped, and commercialized a fully customized OmniTop Sample Tubes® Manifold, offering a GMP-compliant single-use solution tailored to the customer’s needs.
Key Features of the OmniTop Sample Tubes® Manifold:
Closed-System Design: Eliminates the need for a biological safety hood by preventing exposure to contaminants.
Proprietary Multi-Leg Manifold: A 10-leg, platinum-cured, silicone-molded manifold served as the backbone, directing fluid to each conical tube collection vessel.
Advanced Cap Technology: The newly designed conical tube caps featured dedicated ports for fluid inlet and venting, ensuring complete sample retrieval.
Custom Holder for Stability: To enhance user experience, a GMP-compliant plastic holder was designed to secure the tubes and support the manifold, facilitating a streamlined workflow.
Zero Hold-Up Volume: The system allowed for complete fluid collection, eliminating material loss.
By leveraging cutting-edge 3D design and printing technology, Avantor’s engineering team rapidly developed and validated this closed-system solution to meet the manufacturer’s needs while maintaining compliance with biopharmaceutical standards.
Results: Increased Efficiency & Enhanced Sterility Assurance
After integrating the OmniTop Sample Tubes® Manifold into their process, the vaccine manufacturer observed significant improvements, including:
Enhanced Sterility Control: The closed system design eliminated contamination risks, ensuring sterility throughout the sampling process.
Improved Process Efficiency: The streamlined workflow minimized handling steps, reducing operator workload and increasing throughput.
Flexibility in Sampling: The manifold enabled easy collection at multiple time points while supporting different tube materials and volumes.
Standardized Sampling Process: The manufacturer achieved greater consistency and repeatability in bioprocess sampling, improving overall product quality.
The OmniTop Sample Tubes® Manifold provided an adaptable, user-friendly solution that improved both product safety and operational efficiency, demonstrating how innovative closed-system sampling technologies can revolutionize biopharmaceutical workflows.
Avantor Single-Use Solutions: Enabling Bioprocess Innovation
The success of this case study highlights Avantor’s ability to develop customized single-use solutions that optimize biopharmaceutical manufacturing operations. Avantor’s single-use solutions help solve complex fluid-handling challenges while ensuring regulatory compliance and process reliability.
Key Benefits of Avantor’s Single-Use Solutions:
Quality & Choice:
Open-architecture model supporting diverse system requirements.
Comprehensive supplier management program with validated key component sources.
Robust sterility validation programs to minimize contamination risks.
Expertise & Innovation:
Extensive knowledge in fluid handling connectivity and single-use system design.
Rapid prototyping and collaborative development of fully customized solutions.
Conversion support from self-assembled parts to fully integrated single-use systems.
Process Optimization & Efficiency:
Expedited design and approval process: Concept designs in <5 days.
Comprehensive validation packs available within 5 days.
Seamless global logistics footprint for efficient delivery and implementation.
Custom Engineering Solutions:
Fully tailored single-use assemblies for unique applications.
Ability to develop custom components and parts.
Customized skid systems with integrated disposable fluid paths.
Advancing Bioprocess Sampling with Closed-System Innovation
The OmniTop Sample Tubes® Manifold case study underscores the importance of closed-system sampling solutions in modern biopharmaceutical manufacturing. By addressing key challenges such as sterility assurance, efficiency, and process flexibility, Avantor delivered a customized solution that transformed the customer’s sampling workflow.
As the demand for high-quality single-use solutions continues to grow, Avantor remains at the forefront of innovation, providing bioprocess manufacturers with the tools, expertise, and technology needed to enhance production efficiency and maintain regulatory compliance.
For more information on Avantor’s single-use solutions, visit vwr.com/single-use-solutions to explore our comprehensive product offerings and expert support for optimizing your bioprocess workflows.