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Sartorius AG
Weender Landstr. 94-108
37075 Goettingen, GermanyPhone: +49.551.308.0
Fax: +49.551.308.3289
Sartocon® Slice 200 Cassette PESU 3081466802E--SG
Description
PESU Polyethersulfone membranes are membrane polymers that are well established in the biotechnological and pharmaceutical industries. The PESU membrane is a stable polymer that features a broad pH and temperature range. Its wide temperature range makes it possible to sterilise the membrane by either steam or autoclaving. Membrane regeneration, storage and depyrogenation can be accomplished by using NaOH even at elevated temperatures. Because of these features, the PESU membrane is ideally suited for biotechnological applications. PESU cassettes are available in 0.1 µm. polyethersulfone membranes are designed for applications in the biotechnological and pharmaceutical industries. They can be used to remove the following cells from liquids: – mammalian cells – clostridia – yeasts – salmonella – mycoplasma reduction product profile: Polyethersulfone can withstand in-line steam sterilisation without any loss of integrity or changes in membrane retention. Membrane retention is unaffected by re-use.
Regulatory Compliance:
All materials have passed the current USP Biological Test. The filtrate meets or exeeds USP and EP requirements for Sterile Water for Injection with respect to total solids, oxidizable substances, particulate matter, ammonia, chloride, nitrate, sulfate and heavy metals. Quality control: Each filter cassette is individually assigned a serial number, integrity tested and certified. It complies with cGMP requirements for non-fiber-releasing filters and is filed under the Drug Master File Number DMF 5967 by the Food and Drug Administration, Washington, DC. Validation information is available upon request.
Product properties
| Filter Configuration |
Slice 200 Cassette
|
| Filtration area |
0,02 m²
|
| MWCO |
100 kD
|
Technical attributes
| Membrane material |
Polyethersulfone (PES)
|
| pH stability |
2-14
|
| Ultrafilter |
100 kD Polyethersulfone Ultrafilter Membrane
|
| Sartocon |
0,7 m²
|
| Slice |
0,1 m²
|
| Slice 200 |
0,02 m²
|
| Slice Disposable Cassette |
0,1 m²
|
| Polyethersulfone (PES) |
Polyethersulfone Ultrafilter
|
| Cut-off for Ultrafilter |
100 kD
|
| Spacer |
Polypropylene (PP)
|
| Integral Frame |
PVDF
|
| Sealing Compound |
Silicone
|
| Bacterial Endotoxins |
<0.18 EU/mL as determined by the LAL test
|
| Extractables |
Product meets or exceeds the Quality standards set for Sterile Water for Injection by the current USP.
|
| Biosafety |
All materials of this filter element meet the requirements of the current USP Biological Reactivity tests for plastics Class VI, (Systemic Injection, Intracutaneous and Implantation tests).All materials of this filter element meet the requirements of the
|
| Non-Fiber Releasing |
This filter product complies with the title 21of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
|
| Maximum Inlet Pressure |
4 bar
|