The biopharmaceutical industry is rapidly adopting single-use technologies (SUTs) to improve manufacturing flexibility, reduce cleaning requirements, and minimize the risk of cross-contamination. However, it may not be possible for all production facilities to shift over completely to SUTs and they continue to rely on stainless steel (SS) vessels, reactors, and hard-piped process lines for critical operations. Creating a sterile, validated interface between SUTs and SS systems has become an essential requirement for modern bioprocessing.
This is where steam-through connectors play a vital role.
The MDI AseptiLink™ ST Steam Through Connector has been specifically designed to establish a safe, secure, and validated sterile connection between steamable stainless steel processing equipment and gamma-sterilized disposable flow paths used in single-use assemblies.
Rather than replacing existing infrastructure, it enables manufacturers to integrate disposable technologies into existing processing facilities while maintaining sterility and improving operational flexibility.
Why Steam-Through Connections Matter
Sterile fluid transfer is one of the most critical operations in pharmaceutical and biopharmaceutical manufacturing. Whether transferring culture media, buffer solutions, process intermediates, or final product formulations, every connection point represents a potential contamination risk.
Traditional connection methods required open handling or additional aseptic interventions, that increased the downstream contamination risk as well as operational complexity and associated costs.
A steam-through connector helps address these challenges by allowing the connection between the stainless steel system and the disposable assembly to be steam sterilized in place, establishing a sterile pathway before product transfer begins.
Once sterilization is complete, the connector is activated to establish the fluid path while maintaining process integrity.
How Does a Steam-Through Connector Work?
A steam-through connector provides an interface between steamable stainless steel process equipment and a disposable flow path.
The process involves:
- Connection: The disposable assembly is connected to the stainless steel process equipment through the steam-through connector.
- Steam sterilization: The connection is steam sterilized in place before product transfer begins.
- Connector activation: Following steam sterilization, the connector is activated to establish the sterile fluid pathway.
- Sterile fluid transfer: The resulting closed system pathway enables sterile fluid transfer between the stainless steel equipment and the disposable assembly.
Key Applications
Steam-through connectors are suited to a range of bioprocessing operations, including:
- Sterile transfer of culture media and buffers
- Upstream bioreactor feed and harvest operations
- Downstream purification processes
- Integration of gamma-sterilized single-use assemblies with steamable processing equipment
These applications allow manufacturers to adopt single-use technologies without extensive modifications to their existing stainless steel process infrastructure.
Designed for Process Reliability
The AseptiLink™ ST connector is engineered with process safety and operational efficiency in mind. The completely closed, steam-sterilizable design helps minimize contamination risks.
Carefully selected construction materials, including a polysulfone body and platinum-cured silicone seals, are chosen to minimize extractables while supporting reliable performance during sterilization.
The connector is compatible with steam sterilization at 135°C for 30 minutes and gamma irradiation up to 50 kGy, making it suitable for demanding biopharmaceutical manufacturing applications.
Validation and Quality Considerations
In regulated biopharmaceutical manufacturing, product performance alone is not enough—comprehensive validation is equally important.
The AseptiLink™ ST Steam Through Connector is validated for critical quality attributes including:
- Absolute resistance to microbial ingress
- Low bioburden
- Bacterial endotoxin levels ≤ 0.25 EU/mL
- Leak-free performance
- High burst strength
- Biosafety: Complies with USP<88> for Class VI plastics and USP<87> for cytotoxicity
- Low extractables
- No particulate release
These validation results provide documented performance data for quality, engineering, and regulatory review.
Explore Sterile Fluid Transfer with AseptiLink™ ST
Looking to integrate single-use assemblies with existing stainless steel process equipment? Talk to the MDI team about your sterile fluid transfer requirements and explore how AseptiLink™ ST Steam Through Connector technology can support your bioprocessing application.