Electron-Beam Tunnel

Rubrik: Reinraum

(Treffer aus Tech4Pharma, Nr. 02, Seite 84 (2025))

Holzer M | Lehmann F

Electron-Beam Tunnel / An Annex-1-Compliant RTU Transfer System · Holzer M, Lehmann F · Skan
Ebeam Surface sterilization Ionizing radiation Pre-filled/Pre-sterilized RTU packaging material Isolator technology Aseptic transfer The sterilization of surfaces with beta rays (electron-beam, ebeam) has been known for a long time and has been well accepted in the food and medical device industry as well as by the U.S. Food and Drug Administration (FDA) and other regulatory authorities in the pharmaceutical industry [ 1 ]. What is new for the pharmaceutical industry is the speed at which ready-to-use (RTU) packaging material can be aseptically fed into the aseptic filling area of high-speed filling lines using an ebeam tunnel with continuous feeding. With ...

Ebeam surface sterilization of ready-to-use units

Rubrik: Technik

(Treffer aus pharmind, Nr. 10, Seite 969 (2024))

Krebsbach T | Holzer M

Ebeam surface sterilization of ready-to-use units / Krebsbach and Holzer | Ebeam surface sterilization · Krebsbach T, Holzer M · SKAN AG
Electron Beam Aseptic filling Irradiation Surface Sterilization RTU The aseptic filling of sterile products under cleanroom class A conditions (ISO 5) is a regulatory requirement, whereby the use of barrier systems such as isolators or RABS is clearly recommended in Annex 1 to the EC GMP guidelines. An isolator is ideal for the sterile filling of prefilled syringes due to the strict physical separation of process and environment as well as the automated decontamination. Before filling, all surfaces of the filling machine that come into contact with the product are cleaned and sterilized using cleaning in place/sterilization in place (CIP/SIP) processes and all ...