The entire design of the FP sterile platform serves to minimize risks when filling under sterile conditions. It meets all the necessary and relevant EDEHG and cGMP guidelines. Avoiding unsealed openings anywhere in the machine prevents cleaning agents and packaging material from reaching the filling area. Potential ‘dead spots’ in which residues or bacteria can accumulate and spread are eliminated and critical joins between components, in particular, have been optimized in this respect. All angles between adjacent parts and components are set at 90° or greater and have gapless seals that are approved for filling and cleaning.
There are no parts that could be ‘lost’ above the open tube and no surfaces that could be contaminated by particles or lubricants. All product contact parts are electropolished and have a surface finish of ≤ 0.8 μm as standard. Higher surface qualities are available on request.
Preventing dirt from building up around the system is also a priority. Where possible, electricity is connected via a cable channel in the hall floor. The bottom plate, the tube filler rack and the tube infeed are sealed against the hall floor by a skirt.