Method of Packaging and Package for Sensors

Abstract

There are provided methods of packaging and packages that prevent damage of the package contents while maintaining sterility and that limit the negative effects of sterilization on sensors such as enzyme sensors. A method of packaging an enzyme sensor includes providing an enzyme sensor such as a glucose oxidase sensor in a gas impermeable package comprising one or more of oxygen and water, removing a significant portion of the oxygen and water present in the package, and sealing the package. The resulting package comprises the enzyme sensor in an atmosphere that is substantially free of oxygen and water. The package can also include a pressure indicator that indicates when the package has exceeded a predetermined pressure.

Description

CLAIM OF PRIORITY UNDER 35 U.S.C. §119[0001]The application claims the benefit of U.S. Provisional Application No. 61 / 122,246 filed Dec. 12, 2008, entitled “Method of Packaging and Package for Sensors” and assigned to the assignee hereof and hereby incorporated by reference in its entirety.FIELD AND BACKGROUND[0002]The present invention relates to methods of packaging and packages for sensors such as enzyme sensors that prevent damage to the sensor and that maintain sterility of the sensor.[0003]Sensors are known in the medical industry for use in analyzing fluids such as blood. These sensors generally have to be sterilized for use in the medical environment; however, known sterilization methods can result in degradation of sensor performance and a reduction in the sensor's shelf life. In addition, packaging delicate medical devices such as sensors requires that particular care be taken such that damage to either the sensor or the package itself does not occur. In particular, damage...

AI Technical Summary

Benefits of technology

[0007]There are provided methods of packaging and packages that prevent damage of the sensors while maintaining sterility and that limit the negative effects of sterilization on sensors. A method of packaging a sensor such as an enzyme sensor includes providing an enzyme sensor such as a glucose oxidase sensor in a gas impermeable package comprising one or more of oxygen and water, removing a significant portion of the oxygen and water present in the package, and sealing the package. The resulting package comprises the enzyme sensor in an atmosphere that is substantially free of oxygen and water, e.g., having an oxygen content of no more than 1 mm Hg.

[0011]The packaging methods allow enzyme sensors to be produced more quickly and more cheaply than by prior art methods wherein the effects of sterilization are mitigated by controlling bioburden alone. Furthermore, as there are many attributes of sensors that are difficult to control individually at design time, it is possible to design a sensor for the best performance without the need to focus on the effects of sterilization and the methods that must be used to mitigate the effects of sterilization. In addition, the packaging methods allow for a simple but reliable way to package the sensor without increasing mass, which is costly to ship and which can create mask areas during sterilization. These mask areas can make sterilization less predictable and can require higher doses of radiation, thereby possibly further degrading sensor performance.

Problems solved by technology

These sensors generally have to be sterilized for use in the medical environment; however, known sterilization methods can result in degradation of sensor performance and a reduction in the sensor's shelf life.

In particular, damage to the sensor can compromise performance of the device and damage to the package can compromise sterilization of the sensor.

Therefore, the amount of radiation used to sterilize enzyme sensors is preferably limited.

However, maintaining low bioburden levels has the negative effect of increasing production time by requiring additional cleaning steps, increasing production cost by requiring replacement of gowns, gloves and other equipment used to maintain a sterile environment, and reduced yield resulting from the rejection of products not having the desired bioburden levels.

This becomes particularly problematic for more complex devices where the bioburden levels are generally higher or at least much more difficult to minimize.

Furthermore, if the enzyme sensor is exposed to moisture and oxygen during sterilization, it can further reduce the shelf life of the enzyme sensor.

In particular, the formation of ozone by subjecting oxygen and water to sterilization can result in denaturing enzymes.

However, maintaining low bioburden levels has its own issues as discussed above.

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