CONDOMS

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 representativeof 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