This document describes how to use the Integrity Test Kit for small volume devices to integrity test non-vented and vented filter units with membrane surface areas of less than 15 cm2 (2.3 in2). Larger devices can be integrity tested using an Integritest® automated system.
NOTE: The Integrity Test Kit for small volume devices pressure gauge has an accuracy of 2% at mid-range. We certify that the SLTEST000 gauge was calibrated at the time of manufacture, in a system that complies with the most recent revision of ISO®-10012. Although the gauge has been calibrated, we recommend that the gauge be placed into a calibration maintenance program upon receipt. The gauge should be calibrated at least once a year. Depending on the criticality and frequency of use, it may be necessary to calibrate twice a year.
The following materials are needed to run an integrity test on a filter unit:
|Laboratory-grade water||for hydrophilic filter|
|Methanol||for hydrophobic filter|
Additional materials required for testing vented filter units:
|If testing:||Then use …|
|Millex® filter||5–10 mL of wetting ﬂuid|
|Sterivex™ filter||20–30 mL of wetting ﬂuid|
|Other||2–3 mL/cm2 effective membrane area|
Wetting out a vented filter is done with a syringe in the same manner as for the non-vented filter.
However, because the vent "bleeds" pressure, it is not possible to generate enough pressure with a syringe to overcome the vent "bleed". A compressed gas source must be used to generate the pressure required to overcome the vent bleed and reach the filter bubble point. Refer to the assembly drawing on reverse side for an example of how to connect the filter to a compressed gas source using our components XX3002570 and XX6700030. This assembly assumes that the gas regulator has a ¹⁄₄ in. female national pipe thread outlet.
After use, attach ﬂexible tubing to male LuerLok™ connection of the integrity tester. Fill syringe with laboratory-grade water, attach to the female Luer-Lok™ connection, and ﬂush integrity tester with at least 100 mL of water. Separate components at the Luer-Lok™ connections and allow to air dry. Store at room temperature in a clean, dry environment where the gauge is protected from physical damage and shock.
Statement Regarding Compliance with the Pressure Equipment Directive, 2014/68/EU
We certify that this product complies with the European Pressure Equipment Directive, 2014/68/EU of 15 May 2014. This product is classified under Article 4 § 3 of the Pressure Equipment Directive. It has been designed and manufactured in accordance with sound engineering practices to ensure safe use. The product is accompanied by user instructions and bears markings to permit identification of EMD Millipore Corporation as the manufacturer or authorized representative of this product within the European Community. In compliance with Article 4 § 3 of the Pressure Equipment Directive, this product does not bear the CE mark.