In the intricate world of biologic drug manufacturing, maintaining a contamination-free process is paramount. Yet, even the most advanced facilities can face challenges. This case study delves into how a biologic drug manufacturer overcame contamination issues in its media pooling process, thanks to Avantor’s innovative closed-system solution.
The Challenge: Open Media Pooling Risks
The manufacturer’s media pooling process involved transferring media from three 500 mL bottles into a single 2 L bottle within a biosafety cabinet. This required opening and pouring the media, exposing it to potential contamination. The steps were not only time-consuming but also increased the risk of contamination, threatening the integrity of the manufacturing process.
The Avantor Solution: A Closed-System Design
Recognizing the need for a contamination-free process, Avantor collaborated with the manufacturer to design a sterile, closed-system solution. Here’s how it worked:
Customization to Existing Practices: Instead of overhauling existing equipment, Avantor designed a solution compatible with the customer’s tube welding/sealing process, eliminating the need for aseptic connection/disconnection technology.
Integrated Components: The system featured sterile PETG bottle assemblies and tube sets from VWR, part of Avantor. The key components included:
500 mL bottles (10830-296)
Two Drop Clamp PP Tee (10830-694)
2 L bottle (75835-988)
Streamlined Configuration: Using the customer’s tube welder, the components were welded into a closed system. A peristaltic pump facilitated the media transfer, ensuring sterility and precision.
The Results: Efficiency and Contamination Reduction
Implementing the closed-system solution yielded impressive outcomes:
Enhanced Efficiency:
Eliminated the need for a biosafety cabinet, allowing operators to work in an ergonomic setting.
Reduced preparation time, with assemblies ready in less than 15 minutes.
Removed the need for assembling and autoclaving tubing sets, saving over an hour per cycle.
Improved Contamination Control:
Significantly lowered the frequency of contaminations by eliminating open media pooling.
Delivered sterility and reliability throughout the process.
Increased Process Throughput:
Accelerated overall production by simplifying the workflow and reducing downtime.
Avantor’s Single-Use Solutions: Enabling Innovation
Avantor’s single-use solutions exemplify their commitment to solving complex challenges in biopharmaceutical manufacturing. By combining expertise, customization, and a collaborative approach, Avantor ensures production lines keep running smoothly.
Key Advantages of Avantor Single-Use Solutions:
Quality & Choice:
Open architecture model with vertically integrated bags, stoppers, and fittings.
Qualified first and second sources for key components.
Comprehensive sterility validation program to mitigate risks.
Convenience:
Local single-use experts and expedited design approval.
Designs and validation packs delivered within 5 days.
Global logistics footprint and access to over 100 standard products.
Expertise:
Extensive knowledge of fluid-handling connectivity.
Support for single-use and hybrid facilities.
Seamless conversion from self-assembled parts.
Customization:
Fully tailored solutions for specific applications.
Ability to develop custom components and skid systems with disposable fluid paths.
This case study highlights Avantor’s ability to design and implement tailored solutions that not only address immediate challenges but also enhance overall efficiency and reliability. By transitioning to a closed-system approach, the biologic drug manufacturer safeguarded its media pooling process, reduced contamination risks, and streamlined its operations—a testament to Avantor’s innovation and expertise.