Sartocon® Slice Self-Contained Unit | Hydrosart® | 30 kDa | 0.14 m²

Type

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Self-Contained Units with Hydrosart®membrane are 0.14 m² to 14 m² pre-sterilized disposable units suitable for use in cGMP environments.

Pre-flushed, sterile, ready to use
No CIP with associated water flush and validation required, which leads to cost and time savings in set up and validation efforts
High product yield and high sustained flux due to low protein binding membrane
No use of glues and therefore low extractables

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Available molecular weight cut offs: 10 kDa | 30 kDa | 100 kDa | 300 kDa

Available Filtration Areas: 0. 14 m² | 0.28 m² | 0.42 m² | 1.4 m² | 3.5 m² | 7 m² | 14 m²

Language:

en 431.2 kB

en 1.7 MB

en 1.9 MB

Bacterial Endotoxins

< 0.18 EU/mL as determined by the LAL test
Biological Reactivity

All materials of this filter element meet the requirements of the current USP Biological Reactivity tests <88> for plastics Class VI (Systemic Injection, Intracutaneous and Implantation tests).
Extractables

The total amount of extractables is well below the limits established by the current USP unter "Sterile Water for Injection".

MWCO

30 kDa
Non-Fiber Releasing

This filter product complies with the title 21 of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.