The Lipidomic Laboratory authorized by the Italian Health Authority (Health Aut. PG 263274 08/11/2012), located at the Research Area of CNR in Bologna, is dedicated to the execution of the molecular analysis of cell membrane.
The management of instrumental equipment and lab operations connected with the enforcement of the automated analysis procedure for the composition of erythrocyte membrane occur in respect of:
- Specifications of Good Laboratory Practice, involving the organizational processes and conditions under which all operations are planned, conducted, monitored, recorded, and included (Directive 2004/10 /EC, or other international standards recognized as being equivalent by the Commission or the Agency and with the provisions of Directive 86/609 / EEC);
- Operating manuals and formalized procedures, filing the data regarding operations and instrumental check-up;
- Specific procedures for all the lab steps (collection, processing, analysis, archiving and data retention) in respect of PRIVACY and ETHICS rules (Regulation EU 2016/679 of the European Parliament and of the Council of 27 April 2016) and CCTV (Measure April 8 2010).
The laboratory complies with all standard operating procedures (SOP) applicable to the implementation of the lipidomic analysis as requested by the local competent authority.
On the basis of national legislation (Presidential Decree 14 January 1997, DDG 32856/2000) and regional authority, which provide that activate programs of “Quality Audit” (CQI) for specific activities, the Lipidomic Laboratory of Lipinutragen respects all required parameters for the implementation of its analytical protocol (lipidomic analysis of red cell membrane). Planned and regularly performed checks (daily, weekly, monthly, quarterly and annual) of the lab cycles , analytical instrumentations and robotics include testing, calibration and verification, using appropriate standards (also with the synthetically available library of trans fatty acids) and perform audits of gas-chromatographic equipment, as well as ordinary and extraordinary maintenance of all laboratory equipment.
The Lipidomic Laboratory is constantly monitored and subjected to annual inspections by qualified personnel in order to comply with the complex current regulations on specialized subjects such as safety, environment, privacy and management systems (organizational models). The risk assessment document (DVR) is updated annually.
Inside the Lipidomic Laboratory is located the high performance system, i.e., the robotic unit that performs the blood sample work-up, with selection and chemical transformations of mature red blood cell membranes. Robotics has been designed by Lipinutragen researchers and the whole operational proceudres, including calibration and standardization, represents the certified membrane lipidomic analysis protocol. It renders the analysis repeatable and reliable, so that a large number of samples can be processed with high performance.