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Pharmaceutical & Medical Packaging News, November/December 2014

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pmpnews.com • Pharmaceutical & Medical Packaging News November/December 2014 20 Blow-Fill-Seal Enhancing Blow-Fill-Seal Packaging B low-fill-seal (BFS) equip- ment manufacturer Weiler Engineering Inc. is equip- ping its ASEP-TECH blow- fill-seal systems with the NOX FLEX Rapid Biodecontamina- tion system from Noxilizer Inc. The company had sought an alternative to the traditional approaches of using preproduction manual sanitation or steam sterilization of the BFS fill sys- tem shroud, which encompasses the fill needles and electronic modular dosing system. "The critical filling zone of a BFS machine is the enclosed area compris- ing the fill system shroud," explains Chuck Reed, Weiler Engineering's director, sales and marketing. "Wei- ler Engineering sought a non-aqueous solution to provide additional mea- sures of safety to the BFS process by integrating a gas sterilization pro- cess into the fill system shroud of the ASEP-TECH Blow-Fill-Seal System. The unique characteristics of nitrogen dioxide provide this solution. Weiler's patent-pending STERI-Shroud design incorporates the use of the NOX FLEX system by Noxilizer. The NOX FLEX system is an automated pro- cess, which eliminates the variability imposed by human interaction with the manual sanitization method." N o x i l i z e r ' s a u t o m a t e d r o o m - t e m p e r a t u r e N O ₂ - u s i n g t e c h n o l - ogy requires less than one hour for decontamination. Test results from a recent study presented by Noxilizer and Weiler Engineering at the April 2014 PDA Annual Meeting showed "a more than a 6 log reduction in biological indicator organisms (Geo- bacillus stearothermophilus) and more than a 3 log endotoxin reduction," the companies report. "Endotoxins, or pyrogens, are main- ly lipopolysaccharide components of Gram-negative bacterial cell wall frag- ments, which can cause acute febrile reactions (i.e., fever)," explains Reed. "These endotoxins are heat stable and may be present even when viable organ- isms are no longer detectable." In lay- Weiler Engineering's ASEP-TECH BFS system uses NOX FLEX rapid biodecontamination technology. A new approach to decontamination coupled with depyrogenation comes to blow-fll-seal processes. By Daphne Allen Editor

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