Membranes – With the Perfect Pleats for Performance

Related Vendors

Italvacuum, Srl

TRM Filter d.o.o.

ProMinent GmbH

Sartorius AG

Thermal Resistance

Especially during steaming and autoclaving, the cartridges need to withstand extreme thermal stress during the phase of heating and cooling. After steaming, it can be difficult to wet the cartridges in order to perform an integrity test. Difficulties in wetting equate to higher WFI consumption, leading to higher costs as explained above.

The high thermal resistance of this filter enables it to withstand even extreme situations like dry steaming, either in a forward or a reverse direction, without its flow characteristics, wetting behavior or integrity values being affected. Again, the possibility of performing dry steaming entails significant cost savings, as no WFI is needed, as well as provides flexibility in process operations.

Reliable Integrity Testing

Wetting is a must for integrity testing of filter cartridges. As soon as a filter becomes difficult to wet, this tends to increase WFI usage and, even more important, the risk that the cartridge will fail an integrity test. This means that this test has to be repeated, which involves more intense rewetting. It can easily be calculated that a single integrity test generates costs of roughly €600. Therefore, any wetting issue during integrity testing will directly lead to additional costs of at least €600, not to mention expenses incurred for in-house investigation of any integrity test failure. The risk of test failure also significantly increases the subsequent risk of losing an entire product batch. Keeping in mind that the cost of a single batch can easily reach a few hundred thousand Euros, any risk of failing a test or even of losing a batch must be avoided in any case.

Due to its complete wettability, the new filter can be reliably integrity tested even after exposing them to extreme conditions. Single-use applications The trend toward single-use bag systems also poses the requirement of testing filter capsules that are mounted on a bag. To perform a pre-use test, the filters have to first be wetted while mounted directly on the bag system. This requires an additional bag just for collecting the water used to wet the membranes. It enables users to employ the smallest bag size, which also saves costs.

Efficient Filtration Results in Lower Ownership Costs

Extremely reliable integrity testing of the filter eliminates the risk of obtaining falsenegative results, which requires rewetting and retesting. Again, the excellent wetting and integrity testing behavior of these cartridges enable highly economical singleuse systems to be engineered.

The new technologies used in the new sterilizing-grade filter represent a unique combination of benefits. The enlargement of their effective filtration area by TwinPleat technology, combined with their new surface-modified membrane properties, results in excellent filtration performance, coupled with the highest process safety and the lowest cost of ownership.

* The author is Product Manager for Filtration Technologies at Sartorius Stedim Biotech

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