Personal Lubricant Product Safety Studies (Biocompatibility, Condom Compatibility, and Antiviral)

Project Description

MULTIPLE TESTING
USA Product Safety Laboratory needed for multiple studies on personal lubricant including Biocompatibility, Condom Compatibility and Antiviral study
Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process and ISO 10993- 1:2009 as follows:
 Cytotoxicity (ISO 10993-5:2009)
 Sensitization (ISO 10993-10:2010)
 Vaginal Irritation (ISO 10993-10:2010)
 Acute Systemic Toxicity (ISO 10993-11:2006)


Condom Compatibility
The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms to be evaluated in accordance with ASTM D7661-10
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms.


Antiviral study
HSV-2
Model/Study: Plaque Reduction Assay
Study Target: Evaluate the ability of a product to neutralize HSV-2