how are condoms tested?
Safety & Security
If you look at condom packages, you'll come across a lot of phrases like "individually electronically tested", "maximum reliability", and so on. What does this all mean, and what is actually required of condom manufacturers? Curious? Good.
Electronic testing is the only test performed on every single condom, and is what manufacturers mean when they refer to "individual" or "electronic" testing.
To perform the test, a condom is pulled over a metal form called a mandrel. The condom is then placed into the presence of an intense electrical field, which is created in air or water depending on the equipment used by the manufacturer. Because rubber does not conduct electricity, no electricity should reach the metal mandrel under the condom. If the electricity reaches the metal mandrel, it indicates the presence of a pinhole. Any condom failing this test is discarded (machines discard the failures automatically).
Dimensional testing is performed on a random sampling of condoms produced within the same lot. The length, width and thickness of the condoms are precisely measured according to published standards. If the samples do not meet the acceptance criteria, the entire batch is discarded.
Air Burst Testing
Condoms must be able to contain a minimum amount of air pressure and volume without breaking. The actual amount is documented in published standards depending on the condom's width. To perform this test, a random sample of condoms within the same production lot are filled with air until they pop. The air pressure and amount of air inside the condom are measured at the time the condom breaks. If the burst numbers are too low, the entire batch is discarded.
Package Integrity Testing
Once inside their wrappers, condom packaging must remain sealed until opened by the customer. This test checks to be sure the seal is intact. To perform this test, a random sampling of condoms from the same production lot are subjected to a vacuum to ensure there are no air leaks in the wrapper seal. If the tests do not meet the acceptance criteria, the condoms fail this test and the entire batch is discarded.
Condoms must be free of weaknesses that could cause them to leak.
To perform this test, a random sample of condoms from a production lot is filled with water. They are held vertically, and then horizontally, and inspected for any evidence of leaks. Condoms that show evidence of leaks, as described as "seepage, microdroplets or squirters," are considered failures.
In our factories, we take this test further to eliminate potential for human error. The inspector pinches the open end of the water-filled condom and presses and kneads it on absorbent cloth. If the cloth becomes wet, the condom has a leak. If the condoms do not meet the acceptance criteria, the entire batch is discarded.
Condoms are laid flat, and a section is cut out of the center leaving a latex ring. This ring is placed on a testing device that stretches the ring until it breaks. The equipment measures the force required to break the condom and the amount of stretch or elongation at breakage. This information is recorded and used by manufacturers for their internal quality control. Tensile properties (force at break) tests are only performed when a manufacturer makes a claim for “extra strength”.
Different manufacturers have different testing equipment. For this reason, the exact methods of performing the tests will vary somewhat from plant to plant. The standards, however, are the same for every company selling condoms in the U.S. Overseas manufacturers must also comply with the standards and they are routinely audited by the United States Food and Drug Administration (FDA) to ensure compliance.