User Guide: Integrity Test Kit for Small Volume Devices

Introduction

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.

Precautions

• Use the Integrity Test Kit for small volume devices with membrane filter units only. Do not use it to integrity test non-membrane prefilter units.
• Do not use syringes smaller than 50–60 milliliter (mL), because smaller syringes can generate pressures in excess of the filter unit's maximum pressure rating. Consult filter unit user guide to ensure that these pressure limits are not exceeded during the test.
• Do not exceed the integrity tester maximum pressure when using compressed gas to test a vented filter unit.

Materials Required

The following materials are needed to run an integrity test on a filter unit:

• Integrity Test Kit for small volume devices assembly
• 60 mL syringe (preferably Luer-Lok™ fitting)
• Wetting fluid:

  Laboratory-grade water	for hydrophilic filter
  Methanol	for hydrophobic filter

• Sampling tube (cat. no. M00000001) or a 10 cm (4 in.) long piece of 3.2 mm (¹⁄₈ in.) inner diameter (ID) transparent, flexible tubing
  
• 50mL beaker or container

Additional materials required for testing vented filter units:

• Compressed gas source (air or nitrogen) with two-stage regulator
• Luer-Lok™ connection for gas source (e.g., cat. nos. XX3002570 and XX6700030). See Materials.

Integrity Test for Non-vented Filters

1. Aspirate appropriate wetting fluid into the syringe (refer to table above)

   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

   
   
2. Attach the inlet of the filter unit to the male Luer-Lok™ connection on the Integrity Test Kit for small volume devices assembly as shown below.
   
   
3. Attach the flexible, plastic end of the sampling tube to the outlet of the filter unit.
4. Connect the syringe to the female Luer-Lok™ connection of the Integrity Test Kit for small volume devices assembly. If the syringe has a Luerslip connection, hold the syringe onto the assembly at all times during this procedure.
5. Push the syringe barrel to wet the filter unit and deliver the wetting fluid into a container.
6. Disconnect the syringe from the Integrity Test Kit for small volume devices assembly. If there is any liquid left in the syringe, push the syringe plunger to empty.
7. Withdraw the syringe plunger to the 60 mL line to fill the syringe with air.
8. Connect the syringe to the female Luer-Lok™ connection of the Integrity Test Kit for small volume devices assembly. Submerge the open end of the tubing in liquid. Gradually push the syringe plunger to increase the pressure on the filter unit and pressure gauge.
9. Continue to increase the pressure until a stream of bubbles starts to come out of the tubing. This is the bubble point. Record the gauge pressure and compare it to the manufacturer’s minimum bubble point specification. For the typical minimum bubble point value for your filter unit, refer to the Certificate of Quality, or call Technical Service.

Integrity Test for Vented Filters

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.

1. To wet out the vented filter unit, follow steps 1–6 of for testing non-vented filters.
2. Disconnect the syringe from the Integrity Test Kit for small volume devices assembly and connect the assembly to the compressed gas source as shown below. Wrap male threads of XX3002570 and XX6700030 with polytetrafluoroethylene (PTFE) tape before assembling. Submerge the open end of the tubing in liquid.
   
   
3. Increase the gas pressure gradually until you see a stream of bubbles coming out of the outlet tube. This is the bubble point. Record the integrity tester gauge pressure and compare it to the manufacturer’s minimum bubble point specifications. For the typical minimum bubble point value for your filter unit, refer to the Certificate of Quality, or call Technical Service.
4. Turn off the compressed gas source and wait until the pressure gauge on the Integrity Test Kit for small volume devices assembly reads “0”. Disconnect the assembly from the gas source.

Cleaning and Storage

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.