100% reliable quality control
Abbott Diagnostics fills and finishes blood test vials under stringently controlled conditions. The project on which I am working focuses specifically on the finishing operations (filling, labelling, printing, camera-based inspection and vial packaging).
The expansion of their product range, with DataMatrix code and additional information of the bottle and packaging labels (bar code and typeface) required that the quality of product inspection be improved on two existing filling and labelling lines with direct labelling. For this, a Mettler Toledo CI-Vision system has been implemented for 100% reliable quality control. The system checks the 1D and 2D codes, markings, expiration dates, batch numbers and texts. It is also capable of checking packaging characteristics such as the seal, along with cap position or colour. System and test upgrades, qualification and validation activity implementation, along with launch and initial production support, remain to be performed.
Backfitting in the context of serialisation
As of 2019, each new box of medicinal product prescribed in Europe must bear a unique identification number in order to ensure the traceability of medicines. All manufacturers must place a DataMatrix identifier on each box of medicinal product and save all codes in a central database. This information verification improvement project is thus part of the backfitting process with: the EU directive on counterfeiting, the drug supply chain security act (DSCSA), along with other international pharmaceutical safety regulations pertaining to serialisation, monitoring and traceability.
Thanks to this experience acquired in a high-quality, precise and demanding work environment, I was able to gain an understanding of GMP-based company operation in the various departments and to work in a team comprised of various divisions (agapians and Abbott employees).