Description
Description
Designed for single use, eliminating the need for post-use ClP cleaning, regeneration, and cleaning validation. This significantly saves operational time and avoids the risk of cross-contamination.
Pre-treated to reduce TOC and conductivity levels, effectively minimizing endotoxin and bioburden. No need for pre-use alkaline washing to remove pyrogens, enabling rapid experimental setup. Each filter is individually packaged and gamma-irradiated before shipment to ensure sterility.
Effective Length and Scale-Up
The process scale-up feature of hollow fibers is that: direct process scale-up can be carried out as long as the effective length is kept the same.
On the opposite, due to the significant pressure drop difference between inlet and outlet existed in different lengths, the internal pressure and flow velocity distribution of the flow channel also change correspondingly, so linear scale-up can not be performed on devices with different length. When processing with more fouling and high viscosity product, it is preferred to choose module with shorter length.
Features
Pre-sterilized with gamma irradiation at an intensity of 25-45 kGy
Pre-treated to reduce conductivity and TOC residue, minimizing wetting and shortening installation time
Single-use design eliminates the need for post-use ClP cleaning
Applications
Yeast, oncolytic bacteria, and other cell harvesting/purification
Continuous cell perfusion culture
Aseptic concentration of plasmids and mRNA in CGT applications
Aseptic purification of recombinant proteins
Quality Standards
ISO 9001: 2015 Quality Management System
Manufactured for use in conformance with cGMP
Each product is integrity tested prior to release
COA/COQ provided with shipment
Validation documents are available upon request
TSE/BSE certificate available
