Vaginal rings (VRs) are torus-shaped devices, generally fabricated from thermoplastic polymers or silicone elastomers, currently marketed for contraceptive and hormone replacement purposes. Extensive research and development efforts have been focusing on the use of VR technology as microbicide-releasing devices.
Whilst there are currently no international standards for the mechanical testing and minimum performance characteristics of any intravaginal ring (IVR) products, our experts typically test to ISO 8009:2014 and ASTM D6976-13 which are related to diaphragms. As well as this, Smithers offers bespoke and tailored test methods for a more standardised approach to the mechanical testing of VRs and CVRs.
Performance testing of vaginal rings
As an independent testing laboratory we have extensive experience supporting clients with verification testing and processes. Our experts develop and validate bespoke tests used to support regulatory submissions in the EU and US. We can provide you with a comprehensive overview of your product’s performance.
- ASTM D6976-13(2018), Standard Specification for Rubber Contraceptives—Vaginal Diaphragms
- ISO 8009:2014 Mechanical contraceptives — Reusable natural and silicone rubber contraceptive diaphragms — Requirements and tests
- ISO 868:2003 Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness)
- ASTM D2240 - 05 Standard Test Method for Rubber Property—Durometer Hardness
- ISO 37:2005 Rubber, vulcanized or thermoplastic — Determination of tensile stress-strain properties
Mechanical characterization and verification of vaginal rings
To verify that the performance satisfies the design requirements, our experts develop custom testing methods for device characterization. We also help clients tackle device design concerns by developing specific testing that is not addressed by industry standards such as ISO and ASTM. We apply a consultative approach to problem solving. Supported by state-of-the-art device testing facilities, Smithers’ VR testing capabilities include:
- Dimensional Analysis - including, external diameter, internal diameter, cross-section and weight
- Durometer hardness
- Elongation and Tensile properties
- Compression Strength and resistance to fatigue
- Twist resistance under compression
- Visual inspections
Test method development and validation
Our experts develop and validate bespoke tests, which are subsequently used to provide evidence of product conformity for regulatory submissions. For each test method a study protocol is prepared by one our test experts to clearly define the procedures we will employ.
Testing is performed in accordance with the protocol created in the method development phase and the results are then assessed. We work with clients to prepare approved documents to provide evidence of conformity for FDA and EU regulatory submissions.
Validation testing to determine:
- Test protocols and reports
- Validation protocols and reports
- Supporting documentation – such as calibration records
Our laboratories are UKAS ISO 17025 accredited and FDA registered. We are members of International Safe Transit Association (ISTA), the Bioprocessing Systems Alliance (BPSA), and the UK GLP compliance program.