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Midisart® 2000 PTFE 17805----------E

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Midisart® 2000 PTFE 17805----------E
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Midisart® 2000 PTFE 17805----------E

Product properties

 

Type

Air filter

Branch

Pharma / Biotech

Filter Type

Flat disc Capsules

Filtration area

20 cm²

Membrane filter material

PTFE

Pore size

0,2 µm

 

Technical attributes

 

Filter Material

Polytetrafluorethylene (PTFE)

Housing material

Polypropylene (PP)

Bacterial Retention

Quantitative retention of 1 x E7 CFU/cm² Brevundimonas diminuta ATCC® 19146 per ASTM methodology

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).

Sterilisation

Autoclaving: max. 20 cycles at max. 134 °C, 2 bar | 29 psi

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.

GMP Compliance

The product was manufactured in conformance with established Current Good Manufacturing Practice (cGMP) standards.

Operating pressure max.

3 bar

Pack size

12

Membrane material

Polytetrafluorethylene (PTFE)

Connectors Inlet

Hose barb

Connectors Outlet

Hose barb

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