Investigation of Pulsed Light for Terminal Sterilization of WFI Filled Blow/Fill/Seal Polyethylene Containers

Joseph Dunn; Dan Burgess; Frank Leo

Abstract

A study was performed to assess the ability of pulsed light to sterilize water for injection in blow/fill/seal polyethylene containers. Pulsed light uses intense, short duration flashes of broad spectrum white light to produce high levels of microbial kill. In a first phase of testing, containers of 0.5, 5,15, and 120 mL nominal volume were inoculated with Bacillus pumilus endospores, Bacillus subtilus variety niger strain globigii endospores, Bacillus stearothermophilus endospores, and Aspergillus niger conidiospores. Approximately 10⁶ colony forming units of each test spore were individually inoculated into 22 replicate containers of each sample volume. Two of these containers served as inoculation recovery controls, and 10 were treated using each of two pulsed light exposure methods: single-sided treatment or treatment within a reflective cavity. Both treatments employed flashes of intense broad spectrum pulsed light delivered at one flash per second. Cavity treatment used 10 flashes to treat each container within a reflective cavity containing a single lamp. Cavity treatment yielded no recoverable survivors for any of the challenge spores from the contents of any of the 160 total samples. Single-sided treatment used 20 approximately 1-J/cm² flashes from a single lamp-reflector projecting onto one side of the container. Single-sided treatment yielded no recoverable survivors from the contents of the containers for any of the bacterial endospores tested, but Aspergillus niger survival was detected in 4 of the 40 single-side treated samples. A second phase of tests examined the pulsed light inactivation of Bacillus pumilus spores for a range of inoculation levels. High levels of Bacillus pumilus spore kill were obtained using only a few cavity flashes. The results show that pulsed light can provide high levels of microbial lethality and possesses potential for use as a terminal sterilization method for water for injection in filled, sealed polyethylene containers.

Received May 10, 1996.
Accepted December 2, 1996.

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