To meet the growing need to have increasingly controlled and safe products on the market, Alchimia, always sensitive to a policy of continuous improvement, has chosen to test the cytotoxicity of its products in compliance with the ISO 10993-5 standard on two different types of cell lines, BALB 3T3 and ARPE-19, to ensure their absolute non-cytotoxicity.

For the purpose of more rapid information and greater ease of consultation, Alchimia has chosen to show the results of the cytotoxicity test, expressed as compliance with the limits established by the standard, also on product traceability labels, included in the package.

The result of the cytotoxicity test is included in the product analysis certificate, which will be provided upon request.

Below is the list of products tested for cytotoxicity on the BALB 3T3 and ARPE-19 cell line according to ISO 10993-5:

• RS-Blue, dye for the anterior segment;
• TWIN, dye for the posterior segment;
• view ILM, dye for the posterior segment;
• HPF8 and HPF10 perfluorocarbons;
• The RS-OIL and RS-OIL ECS silicone oils.

Find out more about what cytotoxicity is

Sharing and development. These are the two words that gave consistency to the first internal meeting, held in the presence of all the Alchimia collaborators. An opportunity to present the objectives achieved during the year 2018 and the upcoming challenges for a year 2019 of growth both in the technical and in the commercial area, because a company with eyes turned to the future grows thanks to and together with its employees.

From 12 to 16 November, Alchimia hosted the Chinese regulatory authority (CFDA) for an inspection of its Quality Management System in reference to the products already registered or being registered in China, perfluorodecalin HPF10 and the ophthalmic gas GOT Multi C₃F₈, and in anticipation of the registration of other products of the ophthalmic line. The synergy between the Italian staff and the staff of the from our representative office in Beijing made it possible to easily overcome even the linguistic  challenges of an inspection conducted in English and Chinese. The inspectors appreciated the robustness of the Alchimia’s Quality Management System, which also proved compliant with regulations other than those normally applied in Europe, and the competence and helpfulness of the personnel involved in the audit.

In turn, Alchimia appreciated the constructive spirit of the inspection that, due to its close and in-depth nature, allowed a useful comparison and represented a further opportunity for the growth of the company.