What is the water leak test for gloves?

Why is Glove Testing Important?

Glove Tests are used to evaluate dimensions, tensile strength and elongation, puncture, residual powder, leakage, simulated use, heat aging degradation, and viral barriers. These tests are appropriate for rubber, nitrile, and vinyl materials. Nelson Labs performs tests in compliance with ASTM D (rubber exam), ASTM D (rubber surgical), ASTM D (nitrile), ASTM D (vinyl), and ASTM F puncture test standards. Samples are heat aged in an oven.

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Applicable Standards

• ASTM D
• ASTM D
• ASTM D
• ASTM F
• NFPA

What Glove Testing does Nelson Labs Perform? 

The Glove tests are conducted according to current FDA expectations for patient examination gloves (ASTM D), medical surgical gloves (ASTM D), and PVC gloves (ASTM D). It includes adherence to ASTM standards as well as the NFPA standard for physical properties. Glove testing includes:

Tensile test, elastomeric materials (ASTM D412) / Glove tensile test, aged and unaged (ASTM D): The test specimen is cut with the ASTM D412 die C unless otherwise requested. Marks are made 1 inch apart and the median of three thickness measurements is used in calculating the cross-sectional area. The instrument is set up with the crosshead speed to 20 inches per minute and the specimen is inserted into the grips. The elongation of the specimen is measured between the marks with an extensometer. For aged tensile, the gloves are aged at 70° for 3 days (vinyl) or 7 days (Nitrile, latex), allowed to rest for 16-96 hours, then tested. Puncture GLU 140 is also used for fabrics and plastic films.

Whole glove viral barrier (NFPA ): This test procedure is used for evaluating viral barrier properties of whole gloves. Gloves are suspended in a flask filled and subject to the challenge virus (phiX174 bacteriophage) at a concentration of &#;108 plaque-forming units (PFU) per mL. The test samples are agitated throughout a 1-hour challenge on an orbital shaker operated at 100 &#; 115 revolutions per minute (rpm) and then assayed for viral penetration.

Glove heat aging degradation test (ASTM D573, NFPA ): For ASTM D573, the test specimen is conditioned in an oven at 70 ± 2°C for 166 ± 2 hours. For NFPA , the test specimen is conditioned in the oven at 100 ± 2°C for 22 ± 0.3 hours.

Evaluation of leakage in gloves (ASTM D): This test is intended to determine barrier evaluation of gloves by visual and leak test procedures on synthetic and latex examination and/or surgical gloves. The method consists of visual examination of the gloves, securing a test glove to a plastic cylinder, and filling the glove with mL of water. The glove is suspended and examined for visual leaks immediately after addition of the water and at 2 minutes after adding the water.

Puncture resistance (ASTM F): This test method determines the puncture resistance of a material specimen by measuring the force required to cause a sharp-edged puncture probe to penetrate through the specimen.

Glove test for residual powder, aged and unaged (ASTM D): This test is used for the evaluation of residual powder on gloves by weight. The procedure consists of rinsing individual gloves with water, filtering the liquid, and subtracting the tare filter weight from the final filter weight after desiccation.

Glove physical dimensions (ASTM D-91, ASTM D573, ASTM D): This test measures the dimensions of the gloves in millimeters. The length is measured from the tip of the second finger to the outside edge of the cuff. The width of the palm is measured at a level between the base of the index finger and the base of the thumb. The minimum thickness is measured at the tip of the second finger and the palm.

Recommended replicates: Varies depending on the acceptable quality level (AQL) per sampling plan for each individual test. For the ASTM D, 125 gloves are required (surgical or examination) to begin testing. For the whole glove barrier test, 5 gloves are required. For further guidance, please refer to ISO or contact Nelson Labs and we&#;ll be happy to help you determine quantity needed.

This blog is intended to be a practical guide for leak testing gloves and glove sleeves by detailing some actual results that occurred at a client site.  Permission was granted to share this information, but to respect the confidentiality of this client, the company name is withheld.

The results indicated in this blog are applicable to the 2-Piece Glove and Glove Sleeve design shown in the picture above.

The 3 comprehensive leak testing methods for gloves and glove sleeves used at this client site are:

1.  The Ardien Consulting Services Glove Leak Test Apparatus (GLTA).
2.  The SKAN WirelessGT Glove and Glove Sleeve Leak Tester (WGT).
3.  The ammonia leak testing method (ALTM).

For further information on each of these methods, please see the following blog:  Glove Leak Testing

It is advised to perform leak testing of gloves and glove sleeves in the order listed (e.g. GLTA, then WGT, then ALTM).

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The GLTA is a device used to pressurize a glove with compressed air.  After pressurization (typically to around &#; Pascals), the glove is inserted into a vessel containing water.  Bubbles flowing from the surface of the glove denotes a leak.  This method identifies the exact location of the leak.  Based on my validation data, the GLTA has the capability of detecting an approximate 10 micrometer diameter hole in the glove.  For further information, click this link:  Ardien Consulting Services Glove Leak Test Apparatus

The WGT is a battery-powered device that performs a pressure decay leak test (typically to around Pascals) on the glove and glove sleeve combination.  Leak test data and pass/fail results are wirelessly transmitted to a computer.  This method does not identify the location of the leak.  Based on my validation data, the WGT has the capability of detecting an approximate 90 micrometer hole in the glove/glove sleeve combination.  For further information, click this link:  SKAN WirelessGT

The ALTM involves filling a closed and sealed isolator with ammonia vapor.  After a defined period of time to allow the concentration of ammonia to reach optimal concentration conditions, the isolator is pressurized to approximately 150 Pascals.  If a hole is present, the ammonia will be forced out of the hole and into the room.  An operator uses an ammonia-sensitive cloth that changes color when exposed to ammonia in order to identify if there is a leak. This method identifies the exact location of the leak so it can be repaired.  Based on my validation data, the ALTM has the capability of detecting an approximate 200 micrometer hole anywhere in the isolator.

So now that the leak testing methods for gloves and glove sleeves have been explained, it is now time to share some actual results indicated as Steps 1 &#; 4 below.

Step 1:  The old gloves were removed from the existing glove sleeves.  All old gloves were leak tested using the GLTA and no leaks were identified.  All new gloves were leak tested using the GLTA and no leaks were identified.  These new gloves were then installed on the glove sleeves as shown in the picture above.

Step 2:  The glove and glove sleeve combination was leak tested with the WGT.  One of the 4 glove sleeves had a failed result.  The glove sleeve was closely inspected and no pinhole leaks could be found.  The glove sleeve in-question was re-tested and the results indicated a failed result once again.  A different WGT unit was used and the results were the same.

Step 3:  The isolator was leak tested using the ALTM.  Specific attention was applied to the glove sleeve with the failed WGT leak test.  No leaks were identified.

Step 4:  After completion of the ALTM, the glove sleeve in-question was closely inspected internally.  Upon removal of the O-ring that secures the glove to the glove sleeve, a slight fold of the glove material underneath the O-ring was discovered.  This fold was removed, the O-ring was re-installed over the glove to secure the glove to the glove sleeve, and the WGT leak test was performed once again on this glove sleeve.  The leak test passed.

In this special circumstance, the glove had no detectable leaks (as demonstrated by the GLTA), and the glove and glove sleeve had no detectable leaks (as demonstrated by the ALTM), but the WGT discovered there was a leak.  Visual inspection identified the location of the leak was at the interconnection of the glove to the glove sleeve due to this fold in the glove material.  It is suspected that the ALTM did not detect this leak because the pressure was only 150 Pascals compared to the WGT&#;s pressure of Pascals.

These results clearly demonstrate that not all leaks are pinholes in gloves and/or glove sleeves.  In this particular case, the individual that performed the installation of the glove on the gloves sleeve was in the process of being trained and did not fully comprehend the details in the draft SOP.  Nevertheless, results like these are some of the best circumstances for training new operators!

As a result of this finding, the draft SOP was slightly updated to include the following statement:  &#;After installation of the glove on the glove sleeve cuff, carefully pull the glove to remove any folds caught underneath the O-ring.   Creases and/or folds in the glove material may cause the WGT leak test to fail.&#;

As always, this topic is significantly more involved than this brief discussion.  Please contact me if you have further questions or concerns related to glove and glove sleeve leak testing.

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