CONTENTS
- The Condom Gap: A Health Crisis
- Sexual Behavior and Condoms
- Knowledge of Condoms and AIDS
- How Effective Are Condoms?
- New Condoms for the New Millennium
- Improving Access
- Promoting Condoms
- Policies for Condom Use
HIGHLIGHTS
- HIV/AIDS still spreading fast
- Changing the image of condoms
- Behavior change to avoid AIDS
- Ensuring condom quality
- Protecting young people
- Is the female condom promising?
- Sales marketing sales grow
- Condoms: a good investment
April, 1999
Series H, Number 9
Ensuring Condom Quality
Generally, standards are established for size, resistance to breakage, freedom from holes, and packaging and labeling. They also describe how condoms should be tested before marketing for leakage and resistance to breakage (476). Worldwide, three major agencies have established condom manufacturing standards—the International Organization for Standardization (ISO), the Comit Europen de Normalisation (CEN), and the American Society for Testing and Materials (ASTM). In recent years the three organizations have moved toward greater uniformity of standards.
Usually, only new condoms are tested for leakage (476). Artificially aged condoms are tested to assess how well and for how long they will retain their strength after they leave the factory. Once a package is cracked or torn, deterioration of the condom inside is rapid.
 JHU/CCP |
International condom manufacturing standards help ensure consistency in size, resistence to breakage, freedom from holes, and other key criteria. Testing helps assure that standards are met. |
Exposure to ultraviolet light, heat, humidity, and ozone makes latex deteriorate and thus weakens latex condoms (43, 190, 564, 573). The longer condoms are exposed to these conditions, the more easily they break. A new standard from ISO, expected to be approved in 1999, covers condoms intended for tropical climates. These requirements include packaging in impermeable foil laminate, which completely prevents oxidative deterioration even at high temperatures (188, 191).
The World Health Organization (WHO), the United Nations Population Fund (UNFPA), the United States Agency for International Development (USAID) and other organizations that buy large quantities of condoms test them to make sure that they meet purchase specifications, which usually are similar to national standards (207). To make sure condoms have not deteriorated during shipment and storage, institutional purchasers or regulatory agencies can test sample condoms at various points along the distribution chain. Such testing is seldom done, however (119, 201, 207, 324, 598).
Program managers can carry out their own regular visual inspections of random samples taken from all levels of the distribution system. If any of the condoms or their packaging appears damaged, a sample from the affected lot could be sent to a laboratory for testing. In older stocks of condoms deterioration can occur even without any visible damage to the packages (207). If possible, samples should be sent for laboratory testing from any stocks more than three years old (597).
Maintaining consistent high quality has increasingly become a concern as the number of manufacturers around the world has increased (560). Because careful quality control adds to manufacturing costs, unscrupulous manufacturers have an incentive to relax standards or testing. WHO recommends that government procurement procedures include prequalification of suppliers and require lot-by-lot compliance testing (562, 563). In 1998 South African officials had to return millions of faulty imported condoms that had not been adequately tested (438). South Africa tightened its condom specifications and testing requirements soon after the incident (564).
