Aseptic machines
PLÜMAT Aseptic Fill Finish Units
In the field of ASEPTIC filling of bags PLÜMAT is your first choice ONE – STOP partner for filling machines applying oRABS, cRABS or ISOLATOR containment. For the critical process of feeding pre-sterilized components we offer RTP (Rapid Transfer Port), ATS (Aseptic Transfer System) and non-touch feeding options (bags, closures, product). The project flow includes mock-up studies smoke studies and validation support. We combine this with our more than 50 years experience in liquid filling technology for flexible containers.
ASEPTIC bag filling is a process in which drug products, bags, and bag closures are first sterilized separately and then brought together. The step of combining the product, bag and closure is done in a clean room, using a special isolator covered filling machine that is self-contained in a sterile environment. The aseptic filling process is challenging and complex. Due to complexity and the required expertise, it is common throughout the pharmaceutical industry to partner between FILLING machine manufacturer and ISOLATOR manufacturer, assisting each other mutually in the sterile fill-finish manufacturing technology.
When producing a drug through the aseptic manufacturing process, it is essential that aseptic technique is following the cGMP standards (Annex 1). The pharmaceutical industry is evolving to reduce the risks of cross-contamination and consistently deliver sterility assurance. Fully automated and robotized, state of the art, filling machines reduce risks associated with operator engagement. Additionally, automated lines provide benefits in efficiency, precision and flexibility especially when working with oxygen-sensitive products. The use of robotic parenteral filling machines can greatly improve, and eliminate, the human exposure factor.
