Presentation on theme: "CONDOMS A series of presentations developed by TGPSH/GTZ and PSI-TANZANIA."— Presentation transcript:
CONDOMS A series of presentations developed by TGPSH/GTZ and PSI-TANZANIA
Condom quality assurance A presentation developed by PSI-TANZANIA, Tanzania Bureau of Standards and TGPSH/GTZ
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
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.
What are quality condoms? Need to fit penis properly Free from holes Adequate physical strength Correctly packaged to protect them during storage Correctly labeled
What are quality condoms? Condom, packing material and lubricants should not be Toxic Locally irritating Harmful ISO 10993 test methods evaluate safety.
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.
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.
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
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.
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
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
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!
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
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
Testing: Air Burst The test inflates the condom like a balloon measures the volume of air and air pressure needed to burst
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.
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.
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
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)
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.
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!!!
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
Conclusion Quality control during manufacture and post production Properly packed high quality condoms last for at least five years, but probably even longer….
Thank you for your attention I hope you enjoyed this presentation
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