Steriline's aseptic filling machines on the front line for COVID-19 vaccine production

Published: 15-Feb-2021

The Italian company is making an outstanding effort in terms of resources and time management to satisfy the current global need with its innovative filling lines

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 Organisations (CDMOs), filling the mRNA-based vaccine against SARS-CoV-2 developed by the well-known American-German pharmaceutical partnership.

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

A first order arrived at Steriline from a CDMO last summer. The request was for a complete filling line worth 3.6 million euros. 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 authorised for commercialisation by international regulatory authorities. Similar customised projects usually need about one year from the order to the delivery but there was not such a long time. 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.

Capping machine

Capping machine

“In August, – says Federico Fumagalli, Chief Commercial Officer at Steriline – 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 8 companies could have done this, and the client’s choice fell on us”.

To satisfy the request, no Christmas break 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 Federico 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 (FAT) to be completed remotely overpassing the current travelling difficulties and restrictions.

This week, the first Steriline’s 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 Mr. Fumagalli.

Another filling line for vaccines is already under construction and it will soon reach Sweden. This will have a production capacity compared 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 till installation, qualification, validation. The Italian company’s business approach is so good and well appreciated that it recently got also other orders for vaccine’s production from Johnson & Johnson and AstraZeneca’ suppliers. Steriline’s management team is now forecasting a revenue of 44 million euros for the fiscal year 2021, almost doubling the previous result.

Tray loader

Tray loader

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