Contraceptives Testing

Many markets as well as WHO require that the contraceptives must be tested for quality and performance. At VIMTA, we offer testing services for different class of contraceptives as condoms, copper-T and pills. Along with this; we also offer biocompatibility testing for contraceptives as per ISO 10993.

The male condoms are usually made of latex which makes it highly durable; however they may be made of other material too. Though the manufacturing guidelines are clearly defined, any kind of manufacturing defect may result in serious repercussions. It therefore becomes important to test these contraceptives.

The testing is done according to various applicable standards as:

  • ISO 4074: 2015 for Natural Latex Rubber Condoms
  • ASTM D3492 for Rubber Contraceptives
  • WHO’s Specification, Prequalification and Guidelines for Procurement: 2010
  • Schedule ‘R’ of Drugs & Cosmetics

The male contraceptives are tested for various quality parameters as

  • Description and identity mark
  • Visible defects
  • Length, width, thickness
  • Color fastness
  • Quantity of lubricant
  • Burst volume and pressure (before and after aging)
  • Water leakage test (freedom from holes)
  • Force and elongation at break
  • Shelf life and stability
  • Package integrity
  • Packaging and labelling

Copper-T testing is done as per ISO 7439 / NDA 18-680. The test offerings include:

  • Pouch integrity
  • Pouch contents
  • Length of tie
  • Position of copper collar
  • Weight of wire
  • Outer diameter
  • Pull force
  • Pouch burst strength

The Contraceptive Pills are tested as per IP 2014, and can also be tested for any other specific standards.