Steriline’s Aseptic Filling Machines On The Front Line For COVID-19 Vaccine’s Production

To satisfy requests for filling lines, Christmas break at Italy-based Steriline was replaced with double work shifts to satisfy the current global need.

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Filling machine by Steriline
Filling machine by Steriline

The global demand for vaccine doses to prevent future COVID-19 viral infections is growing fast with communities all over the world trying to defeat the sneaky and invisible enemy that brought down healthcare systems, economies, and killed thousands of people. Governments and the pharma industry addressed the most advanced machine builders for the supply of filling lines for the vaccine’s production asking for very tiny and challenging delivery times.

The fight against COVID-19 sees Steriline as one of the main frontrunners, in both Europe and Asia, supplying different lines to several Contract Development and Manufacturing Organizations (CDMOs), filling the mRNA-based vaccine against SARS-CoV-2 developed by the well-known American-German pharmaceutical partnership.

A first order arrived at Steriline from a CDMO last summer. Due to the tremendous threat that the virus was posing worldwide, production should start as soon as possible, waiting then for the vaccine to be officially approved and authorized for commercialization by international regulatory authorities. Similar customized projects usually need about one year from the order to the delivery but such time was not an option. A real race against time started, with the company facing an outstanding effort in terms of resources and time management, but at the end it paid off.

Says Federico Fumagalli, chief commercial officer at Steriline,  In August, a pharmaceutical company, working as a CDMO for the American-German alliance, contacted us looking for a complete production line available in very short time to produce a COVID-19 vaccine. In Europe only eight companies could have done this, and the client’s choice fell on us”.

To satisfy the request, no Christmas break was taken at Steriline, but rather double work shifts were needed with new personnel added and another increment of 10% to the personnel already planned in the coming months.

“We had to engage external workers to support our internal experts and we fulfilled the requirements of the project in only five months," continues Fumagalli. "When I saw the line assembled and ready for the last acceptance test, I was stunned of the very short time we spent for the engineering and development."

To squeeze the standard lead times for approvals, Steriline also leveraged the use of cameras and other live streaming tools to allow customers’ acceptance tests (vFATs) to be completed remotely overpassing the current traveling difficulties and restrictions.

Last week, the first Steriline complete line has been finally delivered to the customer and it will soon produce 12,000 pieces of the vaccine per hour. Luckily, in the recent weeks our German client was able to visit Steriline’s headquarters where machines were installed, and they could then check and approve them for delivery,” concludes Fumagalli.

Another filling line for vaccines is already under construction and it will soon reach Sweden. This will have a similar production capacity to the one described before. Furthermore, Indian partners too came forward to ensure themselves two of Steriline’s high-tech and tailor-made complete lines, producing 18,000 vaccines per hour to be delivered to Asia and Africa.

All the above reflect Steriline’s deep expertise and strong attention to the customer’s need along the full engineering and development process until installation, qualification, validation. The Italian company’s business approach recently garnered other orders for vaccines production from Johnson & Johnson and AstraZeneca’ suppliers.

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