Personal Lubricant Testing (Stability, Biocompatibility and Condom Compatibility)
Project Description
LONG-TERM TESTING
MULTIPLE TESTING
FDA GMP Independent Laboratory needed for testing personal lubricant for stability study, biocompatibility, and condom compatibility to ISO 10993 and ASTM D7661 standards. Will need to be GMP in support of a 510k submission.
Stability study - Accelerated 40C/75RH (t = 0, 3m), CRT 25C/60%RH (t = 0, 6, 12 and 24 m)
Appearance, Clarity, Odor, Viscosity, Micro USP<61> and <62>
Biocompatibility -
Cytotoxicity Direct Contact (ISO 10993-5)
Sensitization Max. Test for Delayed-type hypersensitivity Incl. Historical positive cntrl (ISO 10993-10)
Irritation Mucosa Irritation Test - Vaginal (Direct Application) (ISO10993-23)
System Toxicity Acute Systemic Toxicity Test (ISO 10993-11)
Condom Compatibility ASTM D7661
Project Information
Number:23-00540
Industry:Personal and Intimate Products
