PD Membrane Filtration vs Convention Heat Sterilization
Despite the rigorous safety management of the raw material and transportation processes, any remaining infectious particles or allergenic components are removed using an 18nm PD separation membrane.
Final decontamination is confirmed through full lot bacterial inspection. PD membrane separation is conducted at temperatures below 1°C to prevent bacterial proliferation during processing. Additionally, all safety aspects are verified through post-production allergy testing.
The size of the Japanese encephalitis virus ranges from 20 to 50nm, and the hepatitis E virus is about 30nm. Since no viruses smaller than 20nm have been identified, the 18nm membrane separation ensures the removal of even unknown viruses.
This method is particularly effective because viral heat resistance varies significantly among different types, making membrane separation the most effective means of eliminating the risk posed by unknown viruses and maintaining the active cell shapes.
The membrane separation process also removes heat-resistant spores, including endotoxins and bacterial debris, which pose issues during heat treatment.
For cosmetic raw materials other than placenta, we use 100% pure raw materials without any trace additives (carry-over), ensuring high allergy safety.
Different sterilization rates depending on the processing method
- Heat sterilization : 90~99.9%
- PD Membrane Separation (FILTOM) : 99.9999%
In compliance with the Sterility Assurance Level (SAL) set by the International Organization for Standardization (ISO), a sterilization process necessitates a removal rate exceeding six digits.
Pioneering in this field, our company stands as the world’s first to accomplish sterilization of raw placenta meeting this stringent criterion.
