1. CONDOMS A series of presentations developed by TGPSH/GTZ and PSI-TANZANIA

2. Condom quality assurance A presentation developed by PSI-TANZANIA, Tanzania Bureau of Standards and TGPSH/GTZ

3. Why is quality control important?  Quality important:  To prevent unwanted pregnancy  To prevent sexually transmitted infections  If bad quality, consumers are reluctant to use condoms and negative health consequences are possible

4. Introduction To assure condom quality….  International manufacturing standard for latex condom:  tests the capability of the supplier to produce a quality product  tests the product before it is shipped.

5. What are quality condoms?  Need to fit penis properly  Free from holes  Adequate physical strength  Correctly packaged to protect them during storage  Correctly labeled

6. What are quality condoms?  Condom, packing material and lubricants should not be  Toxic  Locally irritating  Harmful  ISO 10993 test methods evaluate safety.

7. What are quality standards?  Condoms are classified as medical devices, and are regulated by regulatory agencies around the world.  Safety and performance standards are published by national and international regulatory authorities and standards organisations to establish minimum quality standards.  Standards also specify methods to use when testing for quality verification.  The principal standards authority is the International Organsation for Standardisation (ISO), a worldwide federation of national standards bodies.

8. What are quality standards?  To ensure condom quality, the International Manufacturing Standard for latex condoms:  Tests the cqapability of the supplier to produce a quality product  Tests the product before it is shipped  ISO 10993 test methods evaluate safety.

9. How do we verify quality? Lot-by-lot testing:  A lot is a collection of condoms of the same design, colour, shape, size and formulation, that has been produced at the same time, using the same process, raw material and euqipment  Condoms from each lot are selected randomly using sampling tables published by the International Organization for Standardization (ISO 2859-1)  Provides assurance that sample is statistically representative of the entire lot

10. How do we verify quality?  Condoms are tested in  Manufacturers’ laboratories  Independent laboratories  National regulatory laboratories  Buyer receives the laboratory’s report:  If lots pass tests, instructs manufacturer to ship condoms.  If a lot does not pass all the tests, manufacturer is instructed to destroy condoms.

11. How is laboratory testing done?  ISO 4074:2002 - Requirements and test methods:  Burst volume and pressure  Stability and shelf life  Freedom of holes and defects  Package integrity (airtight and impermeable, hermetically sealed package)  Labeling

12. Testing: Dimensions  To measure length, the condom is stretched slightly (up to 10 percent)  The width is measured at a right angle to the length of the condom.  three thickness measurements are made for each sample condom

13. Testing: Leakage or Absence of Holes  In the hang method, the condom is filled with water and a technician observes for leaks  A condom can be filled with up to 20 litres of water!

14. Testing: Leakage or Absence of Holes  In the hang/roll approach the end is tied and the condom is rolled across an absorbent paper looking for water on the paper

15. Testing: Tensile.  A 20 mm-wide sample is cut from the mid- section of the condom  The test stretches this cross-sectional piece (ring) of latex until it breaks  The test measures  the force it takes to break the latex  the length of the latex piece when it breaks  tensile breaking strength

16. Testing: Air Burst  The test inflates the condom like a balloon  measures the volume of air and air pressure needed to burst

17. Testing: Package Integrity A packaged condom is put in a vacuum system  If it is put in a water system, after one minute of vacuum stress, bubbles appear if there are holes in the package or the seal is defective.  If placed in a dry vacuum for one minute, the package should inflate and remain inflated to pass the test.

18. Testing: Lubricant Quantity  To determine the amount of lubricant used in a lubricated condom, the test measures separately the weight of  the packaged condom,  the condom with lubricant,  the lubricant on the condom,  the lubricant in the package,  the cleaned condom and the cleaned package.

19. Testing: Oven Test The oven test indicates how stable the product will be after being stored:  It is being artificially aged in an oven at an elevated temperature for a designated period of time  Then the tensile and/or air burst tests are performed  Results are compared with results for new condoms

20. When is testing done?  At the raw materials(latex) collection site  During and after production by manufacturers  By the buyer (the one who buys from the manufacturer)

21. Who is doing laboratory testing?  Tanzania Bureau of Standards (TBS) tests all condoms distributed and sold in Tanzania  It has up to date equipment, fulfilling international standards.

22. How much does testing cost?  6-10% of the cost of the condom for compliance testing  Testing is important to be sure that condoms are of good quality  - so it is a necessary cost!!!

23. Storage and distribution  Condoms should not be exposed to excessive heat or humidity  Research findings reveal that properly packaged good-quality condoms do not perish in tropical countries

24. Conclusion  Quality control during manufacture and post production  Properly packed high quality condoms last for at least five years, but probably even longer….

25. Thank you for your attention I hope you enjoyed this presentation