Hydrosart® Membranes are stabilised cellulose based membranes that have been optimised for the biotechnological and pharmaceutical industry. The Hydrosart® membrane is a stable polymer that features a broad pH range. Hydrosart is also extremely hydrophilic, making it non-protein binding, virtually non-foul and has extremely high flux. Membrane regeneration, storage and depyrogenation can be accomplished by using NaOH even at elevated temperatures. These features make Hydrosart® an ideal membrane for biological applications. Hydrosart® ultrafiltration cassettes are available in the following nominal molecular weight cutoffs: 2 kD|5 kD|10 kD|30 kD|100kD Applications: Hydrosart® ultrafiltration membranes are designed for use in the biotechnological and pharmaceutical industries. They can be used for the following applications: Oligonucleotide, proteins (albumin - even with 40% EtOH - , hemoglobin), coagulation factors (factor VIII, factor III), vaccines (tetanus, diphteria), monoclonal antibodies. Product profile: Hydrosart® shows minimal adsorption of proteins, viruses, etc. Membrane retention is unaffected by repeated use. The Hydrosart® ultrafiltration membrane can be re-used without any loss of integrity or performance. Hydrosart® ultrafiltration cassettes have been validated to withstand in-line steam sterilization without any loss or changes in membrane retention.
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.
30 kD Hydrosart Ultrafilter Membrane
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<0.18 EU/mL as determined by the LAL test
Product meets or exceeds the Quality standards set for Sterile Water for Injection by the current USP.
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
This filter product complies with the title 21of the Code of Federal Regulations (CFR), section 210.3(b)(6) and 211.72.
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