C12Q1/22

BIOLOGICAL INDICATORS, AND SYSTEMS AND METHODS FOR DETERMINING EFFICACY OF STERILIZATION

A biological indicator includes: a BI housing; a germinant container inside the BI housing and housing a germinant composition; a germinant releaser configured to release the germinant composition from the germinant container; a germinant releaser support supporting the germinant releaser and configured to bring the germinant releaser into contact with the germinant container upon application of a force to the germinant releaser support or the germinant container; a first spore carrier inside the BI housing, the first spore carrier having a plurality of spores deposited at a first surface thereof; and an imaging window at a first surface of the BI housing. A BI reader is configured to detect and quantify the presence of live spores in the BI, and includes an excitation source, a camera for capturing images of the spores over time, and a processor for analyzing the images to determine the presence of live spores.

METHOD FOR VISUALIZING AND QUANTIFYING BIOFILM ON SOLID SURFACES

A method for visualizing biofilm on a solid surface. The method comprises steps of:

(a) providing a solid surface which has been in contact with an aqueous medium and at least a portion of the solid surface potentially is covered with biofilm,
(b) maintaining the solid surface in a horizontal position and covering the solid surface with an aqueous dispersion of carbon particles,
(c) tilting the solid surface at an angle of at least 5° from horizontal to allow excess aqueous dispersion of carbon particles to flow from the surface,
(d) detecting any biofilm present on the solid surface by determining whether there are areas not covered by aqueous dispersion of carbon particles.

METHOD FOR VISUALIZING AND QUANTIFYING BIOFILM ON SOLID SURFACES

A method for visualizing biofilm on a solid surface. The method comprises steps of:

(a) providing a solid surface which has been in contact with an aqueous medium and at least a portion of the solid surface potentially is covered with biofilm,
(b) maintaining the solid surface in a horizontal position and covering the solid surface with an aqueous dispersion of carbon particles,
(c) tilting the solid surface at an angle of at least 5° from horizontal to allow excess aqueous dispersion of carbon particles to flow from the surface,
(d) detecting any biofilm present on the solid surface by determining whether there are areas not covered by aqueous dispersion of carbon particles.

Monitoring System Based on Etching of Metals
20210322587 · 2021-10-21 · ·

Compositions, devices and processes related to etching of a very thin layer or fine particles of a metal are disclosed for monitoring a variety of parameters, such as time, temperature, time-temperature, thawing, freezing, microwave, humidity, ionizing radiation, sterilization and chemicals. These devices have capabilities of producing a long and sharp induction period of an irreversible visual change. The devices are composed of an indicator comprising a very thin layer of a metal (e.g., polyester film having an extremely thin, e.g., about one hundred Angstroms layer of aluminum) and an activator, e.g., a reactant, such as water, water vapor, an acid, a base, oxidizing agent or their precursors, which is capable of reacting with the said indicator. The indicator retains its opacity and metallic luster, e.g., silvery white, mirror like finish of aluminum layer for a long time. The activator destroys the indicator layer including the naturally formed oxide layer. The indicator layer does not have a matrix/binder. As the device becomes transparent from being highly opaque, any color, message or image printed under it become visible at a pre-determined time, thus making the device self reading. A sealing tape or large label made from an activator and an indicator can be used for sealing boxes and monitoring self-life of perishables inside it. Ink formulations composed of a metal powder and a proper activator can be used for monitoring several sterilization processes, such as sterilization with steam. When water is used as an activator, a thin layer of metals, such as that of aluminum can be used as steam sterilization or humidity indicator. The process can also be used for making patterns, printing plates, electronic circuits and RFIDs (radio frequency identification devices).

Monitoring System Based on Etching of Metals
20210322587 · 2021-10-21 · ·

Compositions, devices and processes related to etching of a very thin layer or fine particles of a metal are disclosed for monitoring a variety of parameters, such as time, temperature, time-temperature, thawing, freezing, microwave, humidity, ionizing radiation, sterilization and chemicals. These devices have capabilities of producing a long and sharp induction period of an irreversible visual change. The devices are composed of an indicator comprising a very thin layer of a metal (e.g., polyester film having an extremely thin, e.g., about one hundred Angstroms layer of aluminum) and an activator, e.g., a reactant, such as water, water vapor, an acid, a base, oxidizing agent or their precursors, which is capable of reacting with the said indicator. The indicator retains its opacity and metallic luster, e.g., silvery white, mirror like finish of aluminum layer for a long time. The activator destroys the indicator layer including the naturally formed oxide layer. The indicator layer does not have a matrix/binder. As the device becomes transparent from being highly opaque, any color, message or image printed under it become visible at a pre-determined time, thus making the device self reading. A sealing tape or large label made from an activator and an indicator can be used for sealing boxes and monitoring self-life of perishables inside it. Ink formulations composed of a metal powder and a proper activator can be used for monitoring several sterilization processes, such as sterilization with steam. When water is used as an activator, a thin layer of metals, such as that of aluminum can be used as steam sterilization or humidity indicator. The process can also be used for making patterns, printing plates, electronic circuits and RFIDs (radio frequency identification devices).

MEASUREMENT DEVICE AND EVALUATION METHOD

A measurement device according to one embodiment of the present invention, comprises: a voltage applying part for applying a voltage between electrodes of a biosensor, the biosensor comprising a solid electrolyte and at least two electrodes, and being configured such that the solid electrolyte and the electrodes are in contact with each other; a detection part for measuring a current value flowing between the electrodes when the voltage is applied; and a computing part for providing information resulting from the microorganisms by comparing the current value with a reference value stored in advance in which a current value and at least one type of factor selected from the group consisting of the presence or absence of the biological particles, a proliferative state of the microorganisms, and the presence or absence of expression of pathogenicity of the microorganisms are defined.

Self-contained biological indicator

A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

Self-contained biological indicator

A SCBI useful in ambient air pressure systems is disclosed. The SCBI includes a body which serves as the culture tube, a glass media ampoule, an inoculated stainless steel disc positioned on the top of the glass media ampoule so that the spores are close to the top/opening of the SCBI, filter paper on the top of the body and overlying the disc, and a cap.

SELF-CONTAINED BIOLOGICAL INDICATOR

The present disclosure is directed to self-contained biological indicators wherein a single type of indicator is capable of being used for various sterilization conditions, including sterilization with steam and/or ethylene oxide. In some embodiments, a single type of biological indicator is capable of being used for different steam sterilization conditions having varied temperatures and sterilization cycles.

SELF-CONTAINED BIOLOGICAL INDICATOR

The present disclosure is directed to self-contained biological indicators wherein a single type of indicator is capable of being used for various sterilization conditions, including sterilization with steam and/or ethylene oxide. In some embodiments, a single type of biological indicator is capable of being used for different steam sterilization conditions having varied temperatures and sterilization cycles.