1st sterilizing Pharmaceutical grade, our PUROPORE PHA meets all the prerogatives of a sterilization process. The media polyethersulfone is validated by bacterial challenge ASMTP F838-05 and is rinsed with water non-pyrogenic.
Therefore, the PUROPORE PHA is used in pharmaceutical processes for the water for injection. It is available in single or double membrane layer from 0.1μm.
Technical datas :
- Single or double layer of validated PES membraneavecti, with a sterilizing pharmaceutical grade.
- LRV >10e7 CFU/cm² as ASMTP F838-05
- Porosity of 0,1 µm to 0.45µm
- Surface area 10’’ : 0.55 m²
- Diffusion Test in situ – Steamable in situ @125°C or 137°C
- Initiale pressure drop 90mbars @1m3/h per module of 10’’ @ 0.2µm
- Part Number and Lot number marked on the external cage. Certificate of conformity
- Meet EU.Regulation 10/2011 and amendments (EC) 1935/2004 & 1895/2005 – USP Class VI plastic migration. USP « water for injections » and USP Bacterial Endotoxins (<0,25EU/ml) Validation guide on request