Tuesday, August 29, 2023

Successful FAT of Line 3

Radek Fialka

Chief Business Officer

Since quality and production efficiency are currently the keys to success in the pharmaceutical industry, it is a great achievement for our company to complete the Factory Acceptance Test (FAT) of our new syringe line. A FAT is an important step in the manufacturing process that is performed before a machine or equipment is installed and put into operation.

The main goal of the FAT was to verify the production procedures that will be routinely performed on individual devices. This verification was carried out with regard to a large set of processes – production preparation, the filling process and final cleaning after the production. At the same time, both the functionality of the device and the practicality and feasibility of individual actions were in focus. Both the employees of the manufacturer, Syntegon, and a team of selected employees of oncomed participated in this process to a large extent.

Filling different doses of the product was a key part of the testing. Dosing accuracy was examined as it is a fundamental factor in ensuring the quality of the final product. In addition, the precision of filling and stoppering – key aspects that ensure that each syringe is filled with the correct amount of product and properly closed – were verified.

One of the biggest successes of this testing was the one-hour operation of the line, during which it filled 101 % of the syringes. This performance points out not only the efficiency, but also the capacity of the line to work at a high level with above-standard performance.

After completing all the steps mentioned above, the FAT was evaluated as successfully completed. The line is functional and operable, the supplier can disassemble it, pack it and send it to us to Brno. Subsequently, we will begin to put the line into operation in the company.

11. 6. 2025 | News

We support the 2025 Summer Business Camp

The Summer Business Camp is a project that truly matters. For several years now, it has offered a unique space where young people with an entrepreneurial spirit meet experienced mentors, business leaders, and representatives from the non-profit sector.
read text
11. 6. 2025 | News

We participated in the Generis EPOS 2025 Summit in Düsseldorf

We represented the medac group CDMO at this year’s Generis EPOS 2025 Summit. The European Pharma Outsourcing Summit took place in Düsseldorf.
read text
11. 6. 2025 | News

We participated in the EuroPLX conference in Cascais

Representing medac CDMO, we participated in the 30th edition of the EuroPLX conference, which took place in the Portuguese town of Cascais.
read text