Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Process control in response to analysis
Reexamination Certificate
1999-07-26
2003-03-25
Warden, Sr., Robert J. (Department: 1744)
Chemical apparatus and process disinfecting, deodorizing, preser
Process disinfecting, preserving, deodorizing, or sterilizing
Process control in response to analysis
C422S028000, C422S105000, C422S109000, C422S110000, C422S292000, C422S304000, C422S305000, C422S307000, C053S425000, C053S440000, C141S091000, C141S094000
Reexamination Certificate
active
06537491
ABSTRACT:
FIELD OF INVENTION
The present invention relates generally to a sterilization apparatus having a system for monitoring levels of a sterilant therein, and more particularly to a sterilization apparatus including a sterilant monitoring system operatively joined with the sterilant supply assembly of the sterilization apparatus to monitor levels of sterilant therein, such as hydrogen peroxide (H
2
O
2
) vapor.
BACKGROUND OF THE INVENTION
Aseptic processing of consumable goods, such as nutritional compounds and food products, is typically effected by separate sterilization of the contents and the containers within which the contents are packaged. Subsequent to separate sterilization, the contents are placed in the containers and sealed in a sterile environment for shipment, storage and use.
Sterilization of such containers prior to contacting the desired sterilized contents can be performed efficiently by use of a sterilant such as hydrogen peroxide (H
2
O
2
) vapor. In such a process, the containers are introduced into a sterilization apparatus in which the containers are flushed with hydrogen peroxide vapor. The containers are subsequently flushed with warm air or any other fluid suitable to achieve desirably low levels of residual hydrogen peroxide. This general procedure is highly effective in achieving sterilization of the containers, and likewise can be performed on any other suitable articles that will come into contact with the desired compound.
Notwithstanding the effectiveness of hydrogen peroxide (H
2
O
2
) sterilization, accurate monitoring of H
2
O
2
vapor concentration levels can be problematic. This is due in part to the physical and chemical property changes of hydrogen peroxide vapor under processing conditions, and further due to decomposition upon contact with surfaces of various materials within the processing area. As such, undesired deviation of hydrogen peroxide vapor concentration, and excessive decomposition, can result in loss of sterility of the containers and surrounding aseptic processing area. By contrast, hydrogen peroxide vapor is corrosive in nature, and thus excessive concentration levels can result in detrimental effects to the surrounding equipment and surfaces. Furthermore, and in accordance with government standards, low residual sterilant levels must be maintained for subsequent use of the sterilized containers.
Heretofore, hydrogen peroxide vapor detection systems have been undesirably bulky, as exemplified by conventional near infrared (NIR) analysis apparatus. Additionally, known off-line testing is typically too slow to monitor sterilant levels with sufficient accuracy. Previous arrangements have not provided “real time” monitoring throughout an aseptic processing cycle, and particularly have not been capable of monitoring hydrogen peroxide vapor concentrations within the sterilization apparatus at select locations along the sterilant supply system during actual operations.
In view of the foregoing, it is desirable to monitor the concentration of a sterilant, such as hydrogen peroxide, during sterilization processing. The present invention is directed to a sterilization apparatus having an integral, yet efficient, sterilant monitoring system operatively joined to the sterilant supply of the sterilization apparatus. Substantially continuous monitoring of sterilant concentrations can be achieved as sterilant is employed by the apparatus for effecting sterilization of articles therein.
SUMMARY OF THE INVENTION
The purpose and advantages of the present invention will be set forth in and apparent from the description that follows, as well as will be learned by practice of the invention. Additional advantages of the invention will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.
To achieve these and other advantages and in accordance with the purpose of the invention, as embodied and broadly described, the invention is directed to a sterilization apparatus having a sterilant monitoring system particularly suited to monitor concentrations of the sterilant employed by the sterilization apparatus, such as hydrogen peroxide (H
2
O
2
) vapor. The sterilization apparatus generally includes a sterilization chamber and a sterilant supply conduit to supply a sterilant to the sterilization station for sterilization of at least one article thereat. A sensor chamber is joined in fluid communication with the supply conduit at a select location to allow at least a representative portion of the sterilant from the supply conduit to flow through the sensor chamber. A sterilant sensor is positioned to provide output signals corresponding to detected levels of sterilant within the sensor chamber. Operatively coupled to the sterilant sensor is a data collection circuit to receive output signals from the sterilant sensor as collected data. In this manner, sterilant concentration levels can be monitored continuously during sterilization processing, with the monitoring system operable to provide a greater degree of correlation between the sterilant levels detected within the sensor chamber and actual concentrations of a sterilant acting upon the articles.
Particularly, the present sterilization apparatus includes an enclosure within which an article conveyor operates to move a plurality of containers or like articles along a conveyor path through the apparatus. One or more sterilization stations are located along the conveyor path. Sterilant, such as hydrogen peroxide (H
2
O
2
) vapor in the presently preferred embodiment, is supplied to each sterilization station of the apparatus through a supply conduit for sterilization the articles. For example, the sterilant can be applied in the form of a fog to the external surface of each article at one sterilization station, and injected against the internal surface of each article at a different station. Preferably, the fog applied to the external surface and the vapor injected against the internal surface are applied at different concentration levels to achieve different sterilization values as may be desired.
The sterilant monitoring system of the present invention includes a sensor chamber joined in fluid communication with the supply conduit at a select location to allow at least a portion of the sterilant from the supply conduit to flow through the sensor chamber. A sterilant sensor is positioned to provide output signals corresponding to detected levels of sterilant within the sensor chamber. In the preferred embodiment, the sterilant sensor itself includes a gas-detecting semiconductor element and a heater to elevate the temperature at the gas-detecting semiconductor element. A temperature sensor, such as a thermocouple, also may be positioned to provide output signals corresponding to the ambient temperature proximate the sterilant sensor. Depending upon the type of sensor used, these sensors may be positioned within or integral with a wall of the sensor chamber. The output signals of the temperature sensor are collected in combination with the output signals from the sterilant sensor. Similarly, other sensors to detect operating parameters, such as pressure or relative humidity, also may be provided.
A data collection circuit is operatively coupled to the sterilant sensor, and to the temperature sensor or any other sensor that is provided, to receive output signals from these sensors as collected data. The collected data is processed to provide an output corresponding to the detected levels of the sterilant in the sensor chamber. Processing can be performed by a processor chip or circuit operatively coupled with the data collection circuit at the sensor chamber. Alternatively, correlation between the output signals and the corresponding sterilant levels can be performed by a remote processor located external to the sterilization apparatus. In this manner, signals representative of the collected data are transferred via the data collection circuit by a “hard-wired” configuration to the external processor
Mondiek David A.
Simon Patrick D.
Wang Jianjun
Abbott Laboratories
Soubra Imad
Warden, Sr. Robert J.
Weinstein David L.
Woodworth Brian R.
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