Being able to move fluid aseptically using sterile connections is a critical part of the viral vaccine production process. Sterile connections are responsible for how fluid is transferred from one technology to another unit operation. From upstream to downstream and into final formulation and fill, there are multiple points of fluid transfer in vaccine production. The points of transfer must be sterile and failsafe to avoid lost batches due to contamination and ultimately to ensure patient safety. Too often, creating these sterile connections and processes can take considerable time and resources. One challenge is that many available connectors are difficult to use and thus there is an increased risk of failure.
Kleenpak® Presto sterile connectors
To address these challenges, Pall launched their next-generation Kleenpak® Presto sterile connectors. These connectors offer a unique solution to fluid path challenges, especially in single-use closed vaccine production systems. Proven to maintain sterility when connecting two fluid paths, they are commonly used when sterile filtration cannot be done prior to vaccine filling of syringes or vials intended for patient use. The genderless connection allows for the permanent sterile connection of two fluid streams for a large range of biopharmaceutical applications.
A polyethersulfone peel strip material that protects each connector end, which is integrated on a gamma-irradiated or autoclaved single-use assembly, safeguards sterility. With an easy-to-use “click-pull-twist” mechanism, each connector end is joined, the protective peel strip removed and the connectors actuated.
How it Works
Kleenpak Presto sterile connectors have anti-actuation tabs and a tamper resistant protective cover that ensures that the membrane surface is not disturbed. This is different than other connectors that offer covers that can be removed and replaced, but don’t provide any assurance that the product hasn’t been damaged or corrupted against tampering.
Another important feature is the pull-tabs that provide operators with a guide on how to pull the tabs properly as to avoid any inadvertent failures due to operator error.
The twist-to-lock mechanism provides an intuitive three-step operation and visual indication of a successful connection. The connection can be made even in an unclassified environment without compromising the sterility of the fluid paths.
Quality and Validation
The Kleenpak Presto sterile connector brings enhanced levels of quality assurance with 100% inspection at point of manufacture that allows device traceability, as each device has its own serial number. The manufacturing process employs an automatic vision system that ensures the absence of defects in the membrane and membrane welding
Connectors are available in a variety of sizes and are made from Bisphenol-A (BPA) free Polyethersulfone (PES), which is compatible with a wide range of process fluids and solvents to meet a variety of applications demands.
Pall provides extensive validation data, thus reducing the amount of in-house validation required to implement these devices in manufacturing processes.
To read what others are saying about the Kleenpak Presto Sterile Connectors and to receive a sample, please see Kleenpak Presto Sterile Connectors