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.
Because natural rubber latex is known to become weaker after contact with some lubricants, it is important to show that your lubricant will not reduce the efficacy of 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.
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.
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 as received (baseline) tested 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 condom type =160, plus 40 for each subsequent lubricant in the test cycle.