New in-vitro biocompatibility tests at the OMPG

The OMPG has expanded its range of services in the field of biocompatibility testing. In addition to in-vitro cytotoxicity testing (DIN EN ISO 10993-5), materials can now also be tested for a skin-damaging, i.e. irritating or corrosive effect in accordance with DIN EN ISO 10993-10.

Skin compatibility tests are increasingly required, for example as part of a medical device approval, for chemical reclassification in accordance with the REACH regulation or as a general seal of quality for product developments. It makes sense to test the physiological safety of materials at the initial stage of material selection and modification in order to rule out possible toxic effects in the final product at an early stage.

Three-dimensional human skin models can be used to quantify the cell-damaging effect after exposure to the sample in accordance with OECD 439 and 431. For this purpose, the samples or their extracts are applied to the uppermost skin layer of the skin models cultivated in the laboratory and act on the cells over a defined period of time. After this incubation period, the vitality of the skin cells is determined and the cell damage is calculated by comparison with a control, for example water or physiological saline solution. The samples are classified according to the GHS classification as skin corrosive (category 1), skin irritating (category 2) and not skin irritating (-).

The OMPG has successfully completed method validation using the 22 test substances specified in the standard and can now offer three of the most important tests for determining biocompatibility: in vitro testing for cytotoxic, irritant and corrosive effects. As reliable and fast methods, the newly established tests represent a cost-effective alternative to animal testing and are therefore also suitable for project and process-related controls.

Ask us - we will be happy to advise you, discuss the necessary procedure and the test procedure and prepare an individual offer!

Further research results and the range of services offered by Ostthüringische Materialprüfgesellschaft für Textil und Kunststoffe mbH (OMPG) will be presented at the “K” trade fair (19.10 to 26.10.2016) at the OMPG stand in Hall 07, Stand B24.