ULTA Pure SG 0.2 μm 2" Capsule Filter, 0.5"HB connections, gamma sterilized

Yes. ReadyToProcess capsules are available in 2-inch, 4-inch, 5-inch and 6-inch 10-inch, 20-in and 30-inch sizes for the ULTA Pure SG and HC or ULTA Prime CG and GF products. ReadyToProcess capsules are sterilized via gamma-irradiation and Cytiva maintains a sterility claim on these products.

The most common methodology is to follow the fluid with clean compressed air. For sterilizing grade membranes, it will be necessary to exceed the bubble point (3.38 barg) of the 0.2 membrane to completely recover the fluid in the filter's core.

Please note: The compressed air pressure should be limited during blow down of a ReadyToProcess Filter. The tubing on the inlet of the filter cannot withstand 3.38 barg and should not be pressurized above the operating maximum defined in the product Data file.

ULTA Pure membranes employ an asymmetric membrane structure.

Bioburden reduction filters are not defined by an industry standard. The term "bioburden reduction" is a designation used to describe a class of filters which provide a high level of microorganism retention (i.e., LRV 4-6), but do not yield a sterile effluent under the high bacterial load called for in the ASTM F838-05 test method. Manufacturer claims on bioburden reduction filters vary from "typical" retention data to full validation of a minimum LRV. In practice, most bioburden reduction filters are of a 0.45 or 0.2 µm rating and may yield a sterile fluid in common usage, where bacterial loads are much lower than those used in the ASTM challenge. Nevertheless, process-specific claims of fluid sterilization through the use of a bioburden reduction filter are generally not appropriate.

ULTA Pure filters are compatible with caustic solutions as high as 2N sodium hydroxide.

Air-locking is the situation which occurs when a large air bubble enters a capsule or housing containing a wetted sterilizing-grade membrane. Sterilizing-grade membranes will not pass air at pressures lower than their bubble point and therefore large quantities of air will prevent liquid from flowing through the membrane. This situation can be alleviated by venting the housing or capsule of entrapped air. Once the air is purged, liquid flow through the filter should resume.

This test can only be performed on membrane-based filters (Ulta Pure) but not on pre-filters (Ulta Prime) Integrity testing involves thoroughly wetting the pore structure of the membrane and introducing air or nitrogen on the upstream side of the membrane. The wetted membrane resists the passage of air if the membrane is integral. Either a bubble point or air diffusion test can be used to confirm filter integrity. Refer to the document "NFF Integrity Testing" in the Related Documents tab, for complete details. For testing RTP NFF filters a source of sterile air is introduced (provided by passage through hydrophobic sterilizing grade air filter) via a tee connection off the main flow path upstream of the inlet pressure sensor for that filter.  If the integrity test is being run on an automated instrument, double check all of the parameters of the test to ensure alignment with the product specifications and also make sure that there are no leaks to atmosphere on the upstream side of the filter.

ULTA filters are bi-directionally supported but Cytiva has not validated their reverse flow capability. If an ULTA filter is inadvertently pressurized in reverse, an integrity test should be performed to determine if the filter has maintained its integrity. See question above for more details

ULTA Pure filters are compatible with acidic solutions as low as 1N sulfuric acid.

Please read instructions regarding proper operation of ReadyMates.