All-Synthetic Depth Filter Media Gamma Stability
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Solution Overview
Problem
Conventional depth filtration media in biopharmaceutical production processes have high levels of organic and inorganic extractables, which contaminate therapeutic biological products and require extensive pre-flushing, and are not compatible with gamma irradiation-based sterilization, leading to instability and increased contaminant shedding.
Innovation Solution
Development of an all-synthetic depth filtration media comprising a thermally fused mixture of a polyethylene binder and high surface area synthetic filter aid, eliminating the need for wet-laid production processes and wet-strength binder resins, and providing stability to gamma radiation, thus reducing extractables and pre-flushing requirements.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-generated harmful factors
If conventional wet-laid depth filter media are used, then filtration capability is provided, but high levels of organic and inorganic extractables contaminate the feedstream requiring extensive pre-flushing
Solution Approach 1:
The patent changes the chemical composition parameters of the filter media by using all-synthetic materials (polyethylene binder and synthetic filter aids) instead of natural materials, which fundamentally reduces the levels of organic and inorganic extractables released during filtration operations
Solution Approach 2:
The patent creates a composite filter media structure combining polyethylene binder with synthetic filter aids (such as diatomaceous earth alternatives or synthetic porous materials), forming a new material system that eliminates extractable contaminants while maintaining filtration performance
2Reliability
If conventional depth filter media are used, then filtration is achieved, but the media are not compatible with gamma irradiation sterilization, leading to instability and increased contaminant shedding
Solution Approach 1:
The patent changes the material composition to gamma-radiation-stable synthetic materials, specifically selecting polyethylene and synthetic filter aids that maintain their structural integrity and do not degrade or release contaminants when exposed to gamma irradiation sterilization processes
Solution Approach 2:
The patent employs disposable synthetic filter media that can withstand sterilization and are replaced between uses, ensuring that any potential degradation does not affect product quality since each filter is used only once after sterilization
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The new depth filtration media significantly reduces organic and inorganic contamination, maintains performance after gamma irradiation, and eliminates the need for pre-flushing, ensuring high purity and stability in biopharmaceutical production processes.
Implementation Method 1
The all-synthetic depth filtration media of the current invention is prepared by means of a thermal process to fuse the polyethylene binder to the high surface area synthetic filter aid
Implementation Method 2
high surface area synthetic filter aid
Data Source
AI summary
Depth filtration media for the harvest clarification of a feed stream from cell cultures containing a therapeutic biomol-ecule. The depth filtration media is comprised of a sintered mixture of a polymeric adsorbent and a thermoplastic binder and possess ultra-low extractables and do not require pre-flushing prior to use. Further, the materials of construction used for the sintered depth filter media demonstrate a high stability to gamma radiation and are compatible with gamma-based pre-use sterilization processes.