TABLE II

Comparison of Features of Physical Glove Integrity Test Methods

MethodDetection RateQualitative QuantitativeSelective or CumulativeSuitability for RoutineSpecific Features or Limitations
Flow Test (1.)33–92% depending test pressure appliedQuantitativeCumulative 100%Graphic• dependency from test parameters
• no detection of F 0.4 pinholes
• acceptance limit quantified/set
• can be automated
• multiple glove testing possible
• suitable during production (neg. dP)
Pressure Drop Test (2.)33–83% depending test pressure appliedQuantitativeCumulative 100%Graphic• dependency from test parameters
• no detection of F 0.4 pinholes
• acceptance limit quantified/set
• can be automated
• multiple glove testing possible
Water Breakthrough Test (3.)99%QualitativeSelective 100%Graphic• no detection of F 0.4 pinholes
• only possible in vertical direction
• water removal difficult, wet glove
• not suitable during production
Particle Penetration Test (4.)83%Qualitative81% Selective 19% CumulativeGraphic• no detection of F 0.4 pinholes
• weak detection rate at all fingertips
• complex test preparation
• time-consuming scanning
• dirty glove after testing
Diffusional Test Ammonia (5.)92%Qualitative15% Selective 85% CumulativeGraphic• weak detection at F 0.4 and F 0.6
• needs preparation for indicator towels
• time-consuming scanning
• fast test results
• strong smelling
• not suitable during production
Diffusional Test Peracetic Acid (5.)82%QualitativeSelective 100%Graphic• same as above for ammonia
Diffusional Test Helium (5.)43%Qualitative7% Selective 93% CumulativeGraphic• no detection of fingertip pinhole
• weak detection rate
• bad reproducibility
• complex test preparation
• helium “noise” interferences
• not suitable during production
Visual Inspection (6.)33% Untrained, 99% TrainedQualitativeSelective 100%Graphic• training program required
• depending on individual operator
• time-consuming
• good visibility and direct access required
• almost not suitable during process