ASTDM D7661 Determining Compatibility of Personal Lubricants with

Natural Rubber Latex Condoms

Scope:

This test method measures the change in tensile properties and inflation properties of condoms,
after 60 minutes of contact with a AY Lubricating Gel. Force at break is the principal and most
sensitive variable used in assessing the effect of test substances.

The ASTM D7661 testing process was created to help lubricant producers test if a particular
personal lubricant substantially impacted the tensile and airburst characteristics of an NRL
condom.

Procedure:

As per ASTM D7661 testing, after 60 minutes of immersion in AY Gel gel, the change in tensile
and airburst characteristics of non-lubricated NRL condoms and condom rings, especially force
at break, percent elongation at break, airburst pressure, and airburst volume are examined.
Condoms and condom rings are submerged in a personal lubricant, heated to body temperature,
and then cleaned of excess lubricant. The tensile, and airburst qualities are evaluated. These
features are then compared to condoms and rings that were not lubricated and made to undergo
the same processes. Baseline testing is also done on condoms straight from their packets for
comparison purposes. To confirm the laboratory’s test procedure, a final group is exposed to
mineral oils.

Specimen size:

For ASTM D7661 testing, the specimen should be conditioned at 40°C for 60 minutes.

Data:

For each group of rings and condoms, the mean and standard deviation of the breaking force (N),
elongation at break (%), burst pressure (kPa), and burst volume (L) are measured.
 ASTDM D7661 Determining Compatibility of Personal Lubricants with
Natural Rubber Latex Condoms

Validation Methodologies

The purpose of this guidance is to provide a framework for the determination of the
compatibility of AY Gel Lubricant with Condoms. Three different brands of condoms
were taken for this test as mentioned in below tables. Each brand of condom along with
rings were dispersed in AY gel and then incubated for 60 minutes at 40°C.
Types of Condoms:
Condom Brand#1 Condom Brand#2 Condom Brand#3
Brand Name: Durex Brand Name: Ultra Brand Name: Smart uk life
Lot#1002159822 Lot#22N0059 Lot#22N0027
Exp: 06/2026 Exp: 09/2027 Exp: 06/2027

Parameters to be verified:

Maximum Burst Pressure KPa

 ASTDM D7661 Determining Compatibility of Personal Lubricants with
Natural Rubber Latex Condoms

Conclusion:

The ASTM D7661 testing process was created to help lubricant producers test if a particular
personal lubricant substantially impacted the tensile and airburst characteristics of an NRL
condom.