The device was separated into 2 sections – filling section and closing section respectively, which were separated by a safety glass pane.
The machine is designed and made in accordance with requirements and guidelines of cGMP (EudraLex, Vol. 4) as well as FDA CFR Title 21 part 211. All components coming in contact with the product are made of high-quality stainless steel AISI 316L.
All sealing and gaskets materials in contact with product fulfill the requirements of FDA (CFR 211 part 177) and European Commission Regulation No. 10/2011.
In order to accomplish the task, the machine is equipped with following functional units: