Personal lubricant leakage testing procedures

If you want to sell personal lubricants at your country, the authority will need you register it, and they will ask you a file list to prepare accordingly, and then the lube's viscosity and leakage is a mandatory file, here is the method how to test the leakage of the lube:

Personal Lubricant's Leakage Inspection Method

1 Instruments

vacuum box. It can withstand about one atmospheric pressure difference, and it is fixed together with the vacuum pump and vacuum gauge, and the inside of the box can be observed during the test.

2 Reagents

Submerged in liquid (water), treated with a wetting agent (eg dish soap solution).

3 Sampling

Use special inspection level S-3.

4 Specimen

Individually packed lubricant.

5 Regulation

Samples and test solutions were conditioned at room temperature.

6 Test procedure

Immerse single-pack condoms in a container filled with water in a vacuum box, with the most protruding part of the package surface at least 25 mm from the water surface. Water seeping into the bag is more easily seen if dye is added to the water.

Two or more condoms can be tested at the same time, as long as the above operations are followed, leakage from any part of each package can be observed. Vacuum the test chamber to an absolute pressure of (20±5) kPa. With the increase of the vacuum degree, continuous air bubbles can be observed in the condom packaging. Do not consider the air bubbles that appear alone as leakage. For flexible packaging with little or no headspace, this method cannot be used for reliable evaluation.

Keep the vacuum for 1 min, then release it, uncover the container cap, and check the water seepage of the condom package.

7 Result determination

With the increase of the vacuum degree, or when placed under the specified vacuum degree, if bubbles are generated, indicating that there is leakage in the condom packaging, the sample is unqualified.

If the test liquid is visible in the package, it is a failure.

If there are no air bubbles indicating leakage and no test liquid is visible in the package, the package is considered to be acceptable.

Some countries take the personal lubricant as the cosmetic, and some countries think it's only belong to normal commodity, and there are still a few countries still take lubricant into the medical device's regulation, which will be more complicated in the registration process.