Berkshire Sterile Manufacturing
by Andrea Wagner
Has Pall Corporation accomplished the impossible? Yes, you can perform sterile transfers of products and tangential flow in a non-sterile environment with the assurance that your products will remain sterile.
On December 17, 2014, Pall Corp. held a webinar on their Kleenpak II connectors which covered uses, stability, and validations performed on these devices. The devices come in sizes that range from small female and male connectors up to 1.5 inches. They can be irradiated and steam sterilized and hold pressures from 3 to 4 bars for 30 to 2 days respectively.
The typical uses are transfer of large or small volumes and tangential filtration flow (TFF). The process is a simple 4 steps that allows the operator to see the fluid flow and has visual indicators to check that sterility is maintained. The materials of construction are polysufone and silicon and shown to be very durable in studies conducted by Pall with water and ethanol.
Each component has complete traceability and each comes with a unique lot number. They are also 100% tested prior to release to the end user. There is extremely uniform internal diameters which translate to low pressure drops between the two vessels. A full validation package is available and they are currently doing extended stability testing and will share this data as it becomes available.
These devices will significantly reduce risk of contamination during transfers and allow for more flexibility within the processing environment. Once considered only for small scale clinical production these are now being used in commercial production routinely.
Berkshire Sterile Manufacturing (BSM) looks forward to seeing more devices like these in the future that addresses concerns with sterility assurance, compatibility, flexibility and durability for processing in drug and device manufacture.