This episode of our expansion story is about cleaning. This is another important element in building our new aseptic production line because everything that comes in contact with pharmaceutical products during the filling process, such as glass bottles, glass vessels and various machine tool parts of our filling line must be thoroughly cleaned and sterilized at regular intervals and following specific validated processes to prevent risk of contamination. In order to meet our process requirements for GMP cleaning and sterilization, we’ve teamed up with the Getinge Group (headquartered in Sweden, 10.000 employees worldwide) to provide us with a part washer and autoclave for our new production line.

A safe and efficient filling process

The cleaning and sterilization processes should not be underestimated. Contamination of sterile pharmaceutical products during production must be avoided at all times. As a global leader with a product portfolio designed to help manufacturers to ensure compliance with GMP requirements, working with Getinge was for us only a logical choice to meet our requirements for GMP cleaning and sterilization.

Part washer and autoclave by Getinge

As mentioned earlier, Getinge develops the part washer and the autoclave for our new production line. The two machines will be placed in separate cleanrooms on the same floor as our filling line.

The autoclave is a steam sterilizer designed for reliable contamination prevention by cleaning parts at 121⁰C. It weighs about 1.400 kg and it is built in the small town of Getinge (Sweden). A Quality Process Management System secures ease of validation and fulfillment of global and local regulations.

A part washer is always tailor-made, but due to the deviant size of our fill and finish line – and therefore the size of some machine tool parts of the filling line – Getinge had to come up with innovative solutions to fit our required wash load in the part washer.
The challenge was to design a layout in which all our machine tool parts would fit, in a fixed place, while eliminating water retention and preventing sites for potential biofilm or corrosion. Due to our specific needs because of the deviant size of some of our machine tool parts, the part washer is relatively big and measures around 250 cm (high) x 220 cm (width) x 115 cm (deep). The part washer is built at Getinge in Toulouse (France) and weighs about 1.000 kg.

When the machines are finished in France and Sweden, Getinge will support the installation thereof in our production facility in Oss. Hereby it is important that both machines are adjusted airtight and leak-proof in our cleanrooms.

Procuring an autoclave and part washer from the Getinge Group is another big step in the realization of our new production line and meeting GMP regulations. We will regularly update this website with news about the building process, so stay tuned.

Our new production line is expected to be ready for GMP productions from April 2021 onwards.
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