Percutaneous absorption test
| Regulatory reference: | Proprietary method |
| Claim: | Evaluation of transcutaneous absorption |
| Application field: | Solutions or finished products. |
| Description of the test: | Quantification by HPLC of the amount of an active ingredient permeating the skin barrier of artificial or in vitro 3D skin in Franz’s cells, compared to the total titer of the same substance in the applied product. |
Stability test
| Regulatory reference: | ICH or ISO |
| Claim: | Accelerated stability tests |
| Application field: | Medical devices and cosmetics. |
| Description of the test: | Accelerated stability test according to ICH guidelines and ISO regulatory requirements, for medical devices and cosmetics. |
Posted in Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Accelerated stability test, Substance-based, Surgical devices and medications, Make up, Claim for cosmetics, Claim for medical devices, Accelerated stability tests
Biocompatibility test
| Regulatory reference: | ISO 10993-10 |
| Claim: | Biocompatible |
| Application field: | Finished products, textiles, solid products by eluate. |
| Description of the test: | Biocompatibility test: triple analysis for irritation, cytotoxicity and sensitization potential. |
Evaluation of bacterial adhesion on mammal cells
| Regulatory reference: | Proprietary method |
| Claim: | Inhibition of bacterial adhesion |
| Application field: | Medical devices design to inhibit bacterial adhesion. |
| Description of the test: | Evaluation of bacterial adhesion on mammal cells, performed on the CACO-2 cell line. |
Challenge Test
| Regulatory reference: | ISO 11930 for cosmetics; European Pharmacopoeia for medical devices |
| Claim: | Efficacy of preservatives |
| Application field: | Cosmetics and medical devices. |
| Description of the test: | Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics) and European Pharmacopoeia (for medical devices). |
Posted in Vaginal products and Condom, Filter devices, shielding films and plasters, Heating and cooling products, Mucoadhesive products, Protection and barrier effect, Detergents, Raw materials for medical devices, Substance-based, Surgical devices and medications, Make up, Moisturizers, Preservative systems, Claim for cosmetics, Claim for medical devices, Efficacy of preservatives
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