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Effect of low-energy e-beam irradiation on presterilized COC packaging

: Kleinmann, Stefan; Haag, Werner; Weidauer, André

Pharmaceutical Engineering 38 (2018), Nr.1, S.60-64
ISSN: 0273-8139
Fraunhofer FEP ()
electron beam; packaging; electron beam irradiation

Does electron-beam surface decontamination radiation damage COC syringes? Experimental investigations confirm that no measurable dose is delivered if irradiation parameters are selected correctly. Even a dose of a few kGy (equivalent to a few 0.1 Mrad) would not cause significant change. Aseptic filling of sterile drugs is a critical process in biopharmaceutical manufacturing. Ready-to-use presterilized syringes must be transferred into the isolator for filling. Electron-beam (e-beam tunnel)radiation that decontaminates the outer surfaces of the tubs containing presterilized syringes (and other containers) is generally seen as a best practice solution for high-speed filling lines. Figure 1 shows atypical combination of an e-beam tunnel and a filling line.