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Intimate Lubricant and API Condom Compatibility Testing

Before you can bring your personal lubricant or intimate topical medicinal product to market, you will need to have analysis carried out to demonstrate compatibility with male condoms.

Since natural rubber latex is known to become weaker after contact with some lubricants, it is important to show that your lubricant (or topical treatment) will not reduce the efficacy of this or other contraceptives. It is also essential to show that it will not cause harm to users.

We provide a full suite of testing for personal lubricants, as well as for male and female contraceptives, in our lubricant testing laboratory.

Physical testing in our lubricant testing laboratory is carried out according to several standards:

ASTM D7661 - Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. This standard requires airburst and tensile strength testing, both with and without lubricants. Normally the effect of each lubricant is assessed on three brand of latex (NRL) condoms, plus one brand of isoprene and one brand of polyurethane condom. Each brand chosen should be approved for marketing in the USA.

ISO 19671 - Additional Lubricants for Male Natural Rubber Latex Condoms - Effect on condom strength

ASTM D3492 - Standard Specification for Rubber Contraceptives (Male Condoms). This standard includes: dimensional tests, tensile tests (including accelerated ageing), airburst properties measurement (including accelerated ageing), leakage (including accelerated ageing), packaging examination (including accelerated ageing), and expiration testing.

Similar test regimes are found in ISO 4074 - Natural latex rubber condoms - Requirements and test methods and in NS S 97-034 - Preservatifs masculins en latex de caoutchouc naturel.

Female condoms are considered in ASTM D6976 - Standard Specification for Rubber Contraceptives - Vaginal Diaphragms.

Biological testing is carried out according to ISO 10993 - Biological evaluation of medical devices.

It is important to bear in mind that calculating the number of condoms required for lubricant testing is not always obvious at first sight.

Example of ASTM D 7661 testing for 1 condom type with 5 lubricants:

Condom tested as received (baseline) by airburst and tensile = 40 condoms
Condom Controls, humidified and manipulated and tested by airburst and tensile = 40 condoms
Condom Positive Controls, aged in mineral oil, and tested by airburst and tensile = 40 condoms
Condom Test Samples, humidified and manipulated with lubricant 1, and tested by airburst and tensile = 40 condoms
Total condoms for one lubricant type =160.

Additional lubricants tested in the same study each add a further 40 condoms.