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In bio-pharmaceutical single-use applications, assembling individual components into a fully functional system is a critical step and also one of the highest-risk points in the process. Aseptic connection technology serves as the essential bridge that brings these individual components together into a complete system.
In biopharmaceutical manufacturing, maintaining sterility is a non-negotiable requirement. However, traditional tubing welding requires specialized equipment and skilled operation, making the process time-consuming and labor-intensive. It can also be subject to tubing compatibility limitations and quality risks caused by fluctuations in heat-welding temperature.
With biopharmaceutical facilities performing thousands of connections every year, how can you ensure that every connection is fast, reliable, and aseptic?
Cobetter Lifemeta AC Aseptic Connector provides a smarter, more efficient solution.
I. Operation of the Cobetter Lifemeta AC Aseptic Connector
1. Standard Manual Operation
The Lifemeta AC Aseptic Connector is designed to create an aseptic connection between two pre-sterilized components. Featuring a genderless design, it enables easy aseptic connection in a Grade C environment. The ACM Series requires only four simple steps: Connect, Click, Pull, and Lock.
The Lifemeta AC Aseptic Connector can be supplied as a independent component or assembled with silicone or TPE tubing, it also can be pre-assembled onto other single-use components.
2. A Dedicated Film-Removal Tool for More Standardized Operation
When using aseptic connectors of different brands, operators often need to perform multiple steps, many of which require careful and standardized handling. Excessive or insufficient film-pulling operations may compromise the success of the aseptic connection.
To address this challenge, Cobetter has developed a dedicated film-removal tool for the Lifemeta ACM Series Aseptic Connectors.
Key Features
Standardized Operation
Effectively minimizes variations arising from different operation habits, ensuring a highly consistent film-removal process every time.
Manufacturer-Tested for Reliable Performance
Rigorously tested and validated for performance, the tool is specifically designed to work seamlessly with the ACM Series Aseptic Connectors, providing reliable support for aseptic process integrity and safety.
Operating Steps
II. Working Principle and Quality Assurance
1. Working Principle of the Cobetter Lifemeta AC Aseptic Connector
A single-use aseptic connector is a disposable, specially designed connector to enable aseptic connection between two pre-sterilized components without relying on a controlled clean-room environment.
Cobetter Lifemeta AC Aseptic Connector operates based on a “pull-out film”principle. Each connector half features a sterile protective film that acts as a barrier at the connection interface. Once the two connector halves are joined, the two protective films are pulled out from between the interfaces, allowing the two fluid paths to be connected while maintaining aseptic conditions.
The operator simply needs to remove the protective caps → join and lock the two connector halves together → pull out the sterile films, enabling an aseptic connection even outside a classified cleanroom environment.
2. Quality Assurance
3. Cobetter Vision Inspection System — 100% Visual Inspection of Aseptic Connectors
The Cobetter Lifemeta AC Aseptic Connector incorporates a peel-away sterile barrier film that is removed during operation to establish an aseptic connection. To ensure consistent product quality, Cobetter has developed an advanced vision inspection system to address critical quality control points, including incomplete welding and over-welding defects, potential damage to the sterile barrier film, and proper gasket placement.
Using industrial CCD cameras, the vision inspection system performs comprehensive inspection of the sterile barrier film and other critical components of the aseptic connector. This enables quality control ranging from welding integrity to component assembly, helping ensure the consistent and reliable aseptic connection performance of every product delivered.
III. Application Cases
1. Upstream Cell Culture Processes
In the upstream production of biopharmaceuticals such as monoclonal antibodies, recombinant proteins, and vaccines, aseptic and efficient material transfer is critical to maintaining the stability and consistency of cell culture processes.
Serving as a "bridge" for connections in bioprocessing, the Lifemeta AC Aseptic Connector is used for tubing connections between bioprocess containers and systems, including storage bags, single-use bioreactors, media preparation systems, and buffer storage vessels. It helps establish a safe, reliable, and closed transfer system for applications such as seed cell expansion and high-density cell culture.
Case Study: Application of Lifemeta AC Aseptic Connector in 2D Media Storage Bag
2. Drug Substance Dispensing
Liquid dispensing is a common operation in biopharmaceutical manufacturing. Drug substance (DS) such as monoclonal antibodies, vaccines, and gene therapy vectors, require to be transferred from an upstream storage container into freeze-thaw bags or drug substance storage bags. The dispensing process shall under aseptic, highly precise, and consistent conditions to meet the requirements of subsequent drug product formulation and filling.
As the fluid distribution hub of a dispensing system, the manifold plays a critical role in ensuring aseptic assurance and process flexibility. When used in manifold dispensing, the aseptic connector enables fast and reliable aseptic connections to freeze-thaw bags, helping simplify and streamline the drug substance dispensing process.
Case Study: Application of Lifemeta AC Aseptic Connector in Drug Substance Dispensing Manifold
3. Drug Product Filling
In biopharmaceutical manufacturing, sterilizing-grade filters serve as a critical barrier for ensuring product sterility. To establish a more robust sterility assurance system, redundant filtration strategies are widely adopted, using two sterilizing-grade filtration stages to effectively reduce the risk of microbial passage.
The EU GMP Annex 1 (2022) also imposes stringent requirements on sterilizing-grade filtration processes: PUPSIT (Pre-Use Post-Sterilization Integrity Test) shall be perform to mitigate potential contamination risks associated with the masking effect.
As a pioneer in aseptic processing solutions, Cobetter focuses on addressing key industry challenges by providing customized solutions covering redundant filtration system design and the entire PUPSIT workflow for drug product manufacturing.
The Cobetter Lifemeta AC Aseptic Connector delivers fast connection, reliable aseptic assurance, and ease of operation at the critical aseptic drug product filling processes. It is well suited for integration into redundant filtration systems and PUPSIT configurations, providing a safe, efficient, and reliable connection solution for drug product filling lines.
Case Study: Application of the Lifemeta AC Aseptic Connector in PUPSIT
