Form &ndash fill seal machines use heat sealable flexible plastic package, which is then filled, heat sealed and cut off. Ffs are widely used as medicinal packaging. For any manufacturer of medical products quality assurance is particularly important. It is imperative to strictly adhere to established and validated methods of preparation and procedure. Though all filling procedures are carried out in cleanrooms, one cannot exclude potential risks, such as &bull leakage in hydraulic and cooling system &bull particle generation may have an impact on air cleanliness standards &bull leakage in the actual packaging due to mishandling.