STERINYL
Nylon 6.6 membrane cartridge
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PHARMA market
0,1 - 0,65 µm
The STERINYL cartridge has been designed and manufactured to meet quality and performance requirements for very critical applications. The STERINYL cartridge has a Nylon 6.6 membrane with controlled porosity and offers very high bacterial retention efficiency.
The membrane is pleated with a draining polyester backing that offers excellent resistance to temperature during sterilisation and to variations in hydraulic pressure.
The intrinsic wettability of nylon and polyester facilitates integrity testing. The filters are manufactured in a controlled atmosphere; each filter passes an integrity test. The integrity of the filter is validated in correlation with the results of bacterial tests carried out. The retention threshold is regularly checked on samples.
Features & Benefits
- Easy to test in situ
- Repeatedly steam sterilisable in situ or in autoclave
- Heat-welded construction
- Complies with European regulations for materials in contact with food
- Complies with FDA regulations in accordance with CFR 21
- Complies with USP plastic standard on biological safety
- Low extractability filter even when using solvents
- Validation guide available on request
- Validation guide available on request
Specifications
- Version
-
PHARMA market
- Filtration threshold (µm)
- 0,1 - 0,65
- Materials
- Polypropylene, Polyester, Nylon
- Seals
- EPDM, VITON, Silicon