Oona Korhonen

Wound dressings are applied to open wounds acquired through trauma or surgery to absorb excess wound exudate, and to protect the wound from further mechanical damage and infection. Appropriate testing of different types of wound dressings, including gauzes, hydrogels, films, foam dressings, and hydrocolloid dressings, is required for approval both in the European Union (MDR) and the United States (510(k) submission to the FDA). The EN 13726 standard contains test methods to assess important characteristics of wound dressings including absorption, moisture transmission rate of permeable film wound and fixation dressings, waterproofness, and extensibility. These methods are conducted in vitro, and involve testing the dressing materials under different physical and chemical parameters. We are currently offering the following tests under EN 13726: Annex B and C - Free swell absorptive capacity and fluid retention, Annex D - Absorption under compression, Annex E and O - Fluid handling capacity with air expulsion, Annex F - Fluid donation of amorphous hydrogel dressings, Annex G - Dispersion characteristics of gelling dressings, Annex H and I - Moisture vapor transmission rate of wound dressings, Annex J - Waterproofness, Annex K - Extensibility and permanent set.

We offer extractables and leachables (E&L) testing by USP <1663> and USP <1664> to identify and quantify potential contaminants that could migrate from pharmaceutical packaging systems into the drug product. Extractables are organic and inorganic chemicals released from pharmaceutical packaging into an extraction solvent under laboratory conditions. The specific testing conditions (e.g., solvents, temperature) are chosen to simulate potential stresses on the packaging and differ depending on the extraction study's purpose. Leachables are organic and inorganic chemical compounds that migrate from pharmaceutical packaging materials, components, or systems into the drug product under simulated use conditions. These conditions are tailored to represent the drug product's shelf life, storage, and administration, enabling a realistic assessment of potential patient exposure. Examples of analytical techniques used to characterize potential contaminants include: HS-GC: Detects volatile organic compounds., GC-MS: Identifies semi-volatile organic compounds., LC-MS: Characterizes non-volatile organic compounds., ICP-MS: Analyzes inorganic elements (metals).. E&L tests are always customized to the specific product that is studied. Contact our experts through the form below to get a quote for your material.

Performance evaluation of barrier creams to showcase their efficacy 24 or 48 hours after application. In the test, barrier cream is applied to the skin of human volunteers, and its efficacy is evaluated by measuring the transepidermal water loss (TEWL) after controlled irritation via sodium lauryl sulfate (SLS). The cream can be considered effective if the TEWL in the area where the cream is applied is lower than in the control area. Testing is conducted with 10 or 20 volunteers, and the price of the study depends on the number of volunteers.