Weiler Engineering, Inc.

Jeffrey D Stanley

Andrew W Goll

Charles H Reed

A fill assembly sterilization method and system for a blow/fill/seal machine utilizes a closed loop circulation of sterilant containing gas. A typical sterilant is nitrogen dioxide in humidified air. The closed loop includes a shroud that defines a plenum and encloses the fill system. Optionally, at least one high efficiency particulate absorption (HEPA) filter is provided in the closed loop. Sterility assurance level of 10can be achieved by subjecting the fill system to the sterilizing gas for at least 20 minutes at a temperature in the range of about 18&#xb0; C. to about 30&#xb0; C. Preferred sterilant gas is humidified air containing about 10 to about 20 milligrams of nitrogen dioxide per liter.

Sterilization system for a blow/fill/seal machine

A fill assembly sterilization system for a blow/fill/seal machine utilizes a closed loop circulation of sterilant containing gas. A typical sterilant is nitrogen dioxide. The closed loop includes a shroud that defines a plenum and encloses the fill system. Optionally, at least one high efficiency particulate absorption (HEPA) filter is provided in the closed loop. Sterility assurance level of 10can be achieved by subjecting the fill system to the sterilizing gas for at least 20 minutes at a temperature in the range of about 18&#xb0; C. to about 30&#xb0; C.

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Cary, IL, United States of America

Jeffrey D Stanley