Sartocon^® Slice Disposable Hydrosart^®Cassette 3061860701W--SG

Description

Hydrosart^® is a stabilized cellulose derivative membrane polymer that has been optimized for the biotechnological and pharmaceutical industries. The Hydrosart^® membrane is a stable polymer that features a broad pH and temperature range. Hydrosart is also extremely hydrophilic, making it non-proteinbinding and virtually non-fouling. As a result, it has extremely high flux. Hydrosart^®’s wide temperature range makes it possible to sterilize the membrane by either steam or autoclaving. Membrane regeneration, storage and depyrogenation can be accomplished by using NaOH even at elevated temperatures. Hydrosart^® membranes are designed for use in the biotechnological and pharmaceutical industries. They can be used to remove the following from liquids: – Mammalian cells: CHO BHK – Bacteria: E. coli Pasteurella C. diphtheria – Yeasts – Cell Iysates Product. Hydrosart^® has minimal adsorption of proteins, viruses, etc. Membrane retention is unaffected by repeated re-use. Hydrosart^® has been validated to withstand in-line steam sterilization without any loss of integrity or changes in membrane retention.

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 Disposable Cassette
Filtration area	0,1 m²
Pore size	0,2 µm

Technical attributes

Membrane material	Hydrosart®
pH stability	2-14
Membrane type
Microfilter	0.2 µm Hydrosart Microfilter Membrane
Sartocon	0,6 m²
Slice	0,1 m²
Slice 200	0,02 m²
Slice Disposable Cassette	0,1 m²
Hydrosart®	Hydrosart® Microfilter
Pore size for Microfilter	0,2 µm
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