Page 1 of 7

Document No. / Revision

Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
07-March-2017 / RDN

Operations Manual for the

Glove Leak Test Apparatus
(GLTA)

Actual item may be slightly different than photo due to recent

improvements both in design and appearance. General function is
not affected.

Contents, design and layout of this document are the CONFIDENTIAL property of
Ardien Consulting Services LLC,
Any dissemination, distribution, or copying in its entirety or partially is strictly prohibited.
 Page 2 of 7
Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

TABLE OF CONTENTS

Title Page………………………………………………………………………………………………. 1

Table of Contents……………………………………………………………………………………... 2

1.0 Introduction……………………………………………….…………………………………….……. 3

2.0 Safety…………………………………………………………………………………………….……. 3

3.0 Material Specifics……………………………………………………………………………………. 3–4

4.0 Required Utilities…………..………………………………………………………...……………… 4

5.0 Glove Leak Test Procedure…………………………………………………………………….…. 5–7

6.0 Maximum Frequency of Glove Leak Testing……………………………………………..……. 7

7.0 General Cleaning………………………………………..…………………………………………... 7

8.0 General Troubleshooting……………………………………………………………………..……. 7

Glove Leak Testing Log ……………………………………………………………………….…... 1 of 1

Glove Tracking Log……………………………………...………………………………………..... 1 of 1

 Page 3 of 7
Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

1.0 Introduction

The Glove Leak Test Apparatus or GLTA is a device used to pressurize a glove with
compressed air. After pressurization (typically to around 15 – 20 inches of water column
which equates to approximately 3500 – 5000 Pascals), the glove is inserted into a vessel
containing water. Bubbles flowing from the surface of the glove denotes a leak. The
GLTA identifies the exact location of the leak. Based on validation data, the GLTA has
the capability of detecting an approximate 10 micrometer diameter hole in the glove.

2.0 Safety

2.1 The GLTA weighs approximately 7 lbs. Use caution when carrying unit. A cart is
recommended for general transport.

2.2 Use safety glasses when using the GLTA because the procedure involves the
use of compressed air.

3.0 Material Specifics

3.1 Glove Leak Test Apparatus (GLTA)

3.1.1 Material: AISI 316L stainless steel.

3.1.2 All welds continuous. Ground and polished throughout.

3.1.3 Electropolished and passivated.

3.1.4 Proprietary design.

3.2 Industrial Quick-Disconnect Female Socket with Threaded NPTF Male End

3.2.1 Material: AISI 303 stainless steel.

3.2.2 Seal: Buna-N rubber.

3.2.3 Socket locking type: push to connect.

3.2.4 Size: ¼” coupling size, ¼” pipe thread.

3.3 Industrial Quick-Disconnect Male Plug with Barbed Male End

3.3.1 Material: AISI 303 stainless steel.

3.3.2 Straight-through, non-valved, open-flow.

3.3.3 Size: ¼” coupling size, ¼” hose internal diameter.

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Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

3.4 Tubing/Hose

3.4.1 Material: High-temperature silicone rubber.

3.4.2 Size: ¼” internal diameter, ½” outer diameter, ⅛” wall.

3.5 O-Rings

3.5.1 Material: Silicone rubber.

3.5.2 Size: 0.210” wall, 3.725” internal diameter, 4.145” outer diameter.

3.5.3 Size: 0.210” wall, 3.600” internal diameter, 4.020” outer diameter.

3.6 Pressure Gauge

It is recommended to calibrate the Pressure Gauge once on-site.

3.6.1 Measurement pressure range: 0 – 30 inches of water.

3.6.2 Accuracy: ± 1% full scale.

3.6.3 Case material: AISI 304 stainless steel.

3.6.4 Lens material: glass.

3.6.5 Connection material: brass.

3.6.6 Hose barb adapter material: AISI 304 stainless steel.

3.6.7 Hose barb adapter size: ¼” pipe thread, ¼” hose internal diameter.

4.0 Required Utilities

4.1 Compressed air.

NOTE: If a compressed air source is not available, this portable oil-free electric
pump is recommended:

https://www.mcmaster.com/#4176k11/=16l0739

4.2 Sink or suitable vessel containing water.

 Page 5 of 7
Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

5.0 Glove Leak Test Procedure

The Glove Leak Test Apparatus (GLTA) weighs approximately 7 lbs. Use caution
when carrying unit. A cart is recommended for general transport.

Use safety glasses when using the GLTA because the procedure involves the use
of compressed air.

5.1 Place the GLTA on a flat surface.

5.2 Stretch the cuff end of the glove around the GLTA. Place the integrated O-Ring
of the glove in the groove closest to the base of the GLTA. See Picture 1.

Picture 1

5.3 Apply at least one O-Ring around the cuff of the glove to secure the glove in
place to the GLTA. Place O-Ring(s) in the groove closest to the top of the GLTA.
See Picture 1.

5.4 Connect the open end of the ≈ 5-foot piece of tubing to a pressure supply port.
Connect the other end of the tubing to the GLTA via the quick-disconnect fitting.
Using a gradual supply of air, pressurize the glove until firm when pressed and/or
approximately between 15 and 20 inches of water column pressure.

NOTE: Depending on the diameter of the integrated O-Ring of the glove or the
tightness of the added O-Ring(s), it is possible that the glove may slip from the
groove closest to the base to the groove closest to the top of the GLTA when
pressurized. This is normal.

5.5 Disconnect the ≈ 5-foot piece of tubing from the GLTA via the quick-disconnect
fitting. Connect the Pressure Gauge to the GLTA via the quick-disconnect fitting
as indicated in Picture 2. Confirm the pressure within the GLTA is between 15
and 20 inches of water column pressure. If it is not repeat Step 5.4, or relieve
some pressure from the GLTA by performing Step 5.11.
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Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

Picture 2

5.6 Disconnect the Pressure Gauge from the GLTA via the quick-disconnect fitting.

DO NOT submerse the pressure gauge in water.

5.7 Transport the GLTA to a suitable container filled with water.

5.8 Submerse the glove into the water and observe for the presence of bubbles in
the water. Rotate the glove in the water so that all surfaces of the glove can
easily be viewed. Bubbles flowing from the surface of the glove denotes a leak.
Discard the glove if it has a leak. Document results in the form entitled, “Glove
Leak Testing Form”.

NOTE: Bubbles flowing from the back of the glove (near the integrated O-Ring of
the glove) do not constitute a leak in the glove. In such case, try applying
pressure to the added O-Ring(s) in the groove by pressing on the O-Rings with
your hands or use O-Rings with a slightly smaller diameter.

5.9 Dry the glove and GLTA using low-particulate wipe(s).

5.10 Clean the glove using low-particulate wipe(s) saturated with 70% isopropyl
alcohol.

5.11 When leak testing of the glove is complete, remove pressure from within the
GLTA. This can be done by connecting the ≈ 5-foot piece of tubing via the quick-
disconnect fitting on the GLTA and then disconnecting the other end of the tubing
from the pressure supply port.

5.12 Remove the O-Ring(s) and the glove from the GLTA.

5.13 If the glove is a new glove, identify the glove in accordance with the form entitled,
“Glove Tracking Log”.

5.14 Re-install the glove per the form entitled, “Glove Tracking Form”.
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Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

5.15 Document results in forms entitled, “Glove Leak Testing Form” and “Glove
Tracking Form”.

5.16 When all testing is completed, empty the water into a sink. Store Glove Leak
Test GLTA and all accessories in a suitable area or cabinet so these items will
not be damaged or dropped.

6.0 Maximum Frequency of Glove Leak Testing

6.1 Monthly
25 - 35 days (30 +/- 5 days) after previous testing entry (under routine
conditions).

NOTE: This procedure should also performed after three (3) successive isolator
pressure leak test failures that automatically run prior to the isolator’s
decontamination cycle.

7.0 General Cleaning

7.1 This method includes the general cleaning procedure for the Glove Leak Test
Apparatus, Quick-Disconnect Fittings, Tubing, O-Rings, and the Pressure
Gauge.

7.1.1 Clean items/components using low-particulate wipe(s) saturated with

70% isopropyl alcohol. Allow to dry.

8.0 General Troubleshooting

8.1 Refer to this Operations Manual.

8.2 Please feel free to contact Ardien Consulting Services if there are any technical questions
related to the content of this document or the Glove Leak Test Apparatus.

8.3 Contact Ardien Consulting Services.

8.3.1 Name: Rick Nieskes

8.3.2 Email: rick@ardienconsulting.com
8.3.3 Telephone: 262-548-9748
8.3.4 Cell: 262-853-9748
 Page 1 of 1
Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

Glove Leak Testing Form

Performed By:
Specified Observations
Initials / Date

 Existing Glove
Glove tested
 New Glove

Glove Code (see the form entitled, “Glove Tracking Form”).

If applicable, otherwise enter “New” in the Observations

column.

No leaks detected?

If no leaks detected, circle “Pass”.

Pass / Fail
If leak(s) detected, circle “Fail”.
If leak(s) detected, discard glove, and repeat testing with a
replacement glove.

Location of leaks, if applicable.

Otherwise enter “N/A” in the Observations column

Glove acceptable for use?

Pass / Fail
If no leaks detected, circle “Pass”.
If leaks detected, circle “Fail”.

After completing this form, complete the form entitled, “Glove Tracking Form”.

Comments:

Reviewed By (Initials / Date):

 Page 1 of 1
Document No. / Revision
Operations Manual for the Glove
Operations Manual for the Glove Leak Test Apparatus
Leak Test Apparatus, Rev. 3
Revision Date / Initials
01-Sep-2017 / RDN

Glove Tracking Form

Number of Times
New or Leak Test the Glove Has Been
1 Existing Acceptable? Re-Installed in the Performed By:
Glove Code Glove?
2 Isolator? Initials / Date
(New, Ex) (Y, N)
3
(0, 1, 2, etc., D)

Y = Yes, N = No, D = Discarded, New = New Glove, Ex = Existing Glove

1
: On a flat surface of the glove, write the Glove Code using a fine tip marker. Glove Code = “DDMMMYY”- GP”##“,
where “DDMMMYY” is the date the new glove was installed (e.g. 01SEP17 or 01Sep17) and the “GP##” is the Glove
Port Number (e.g. GP01). Initial and date after the Glove Code was written. Install the glove in the identified glove
port.
2
: If the glove leak test failed, discard the glove, and write in “N” for this column, and “D” for the remaining columns.
3
: When a NEW glove is installed, record “0” in this column. A glove may be removed, leak tested and re-installed
repeatedly for up to 90 days, if no leaks in the glove have been detected. After 90 days have elapsed, discard the
glove.

Comments:

Reviewed By (Initials / Date):