A cell detection device that detects a cell in a specimen with high sensitivity and includes a sealed container having a sealable specimen introduction portion, a culture portion that holds a culture solution, an extraction reagent portion that holds an extraction reagent, and a luminescent reagent portion that holds a luminescent reagent, a contact mechanism that controls contact between the culture solution, the extraction reagent, and the luminescent reagent, a photodetector that detects luminescence from the luminescent reagent portion, and a calculator that determines growth of a cell based on a detection signal of the photodetector. The culture solution, the extraction reagent, and the luminescent reagent are separately disposed in the sealed container, and the contact mechanism brings the culture solution to which a specimen is added and the extraction reagent into contact to obtain an extraction solution, and intermittently brings the extraction solution and the luminescent reagent into contact.

A cell detection device that detects a cell in a specimen with high sensitivity and includes a sealed container having a sealable specimen introduction portion, a culture portion that holds a culture solution, an extraction reagent portion that holds an extraction reagent, and a luminescent reagent portion that holds a luminescent reagent, a contact mechanism that controls contact between the culture solution, the extraction reagent, and the luminescent reagent, a photodetector that detects luminescence from the luminescent reagent portion, and a calculator that determines growth of a cell based on a detection signal of the photodetector. The culture solution, the extraction reagent, and the luminescent reagent are separately disposed in the sealed container, and the contact mechanism brings the culture solution to which a specimen is added and the extraction reagent into contact to obtain an extraction solution, and intermittently brings the extraction solution and the luminescent reagent into contact.

A method is for the detection of presence or absence, quantification, and identification of target microorganisms, such as bacteria, bacterial fragments (e.g., LPS, endotoxin), viruses, fungi as well as other pathogens by means of chemiluminescence. The method include providing a medium with one or more target analytes, target microorganisms or target metabolites, adding a dioxetane compound to the medium so that the dioxetane compound emits light, and detecting the emitted light.

The invention relates generally to the field of detection of biological contaminants on a surface, specifically to a method comprising the steps of providing one or more pieces of sterile and nucleotide-free adhesive fibrous material, affixing said one or more pieces of the fibrous material to said surface, collecting said one or more pieces of the fibrous material from said surface, incubating said one or more pieces of the fibrous material in a solvent, and analyzing the solvent for the presence of biological contaminants. The invention further relates to a kit of parts comprising sterile carriers and instructions to be used for long-term monitoring of microbes.

The invention relates to a system for testing the sterility of radioactive substances, to the use of the system for testing the sterility of radioactive substances, preferably radioactive pharmaceuticals and/or diagnostic agents, and to a method for testing the sterility of radioactive substances, wherein the system comprises an isolator (8) having a device for membrane filtration (9) and a filter bottle (1) surrounding the shield (5) against ionising radiation.

A method and apparatus of aseptic processing and production of cells in a non-sterile enclosure apparatus without chemical biocides is disclosed, by controlling the level of humidity throughout the enclosure to 25% relative humidity (RH) or less, and preferably 20% or 15% or less RH. In addition, the temperature is controlled to 37° C., and consistent gas flow is maintained the enclosure. Colony forming units from microbial contamination detected by environmental monitoring within the enclosure are significantly reduced in this method.

A method and apparatus of aseptic processing and production of cells in a non-sterile enclosure apparatus without chemical biocides is disclosed, by controlling the level of humidity throughout the enclosure to 25% relative humidity (RH) or less, and preferably 20% or 15% or less RH. In addition, the temperature is controlled to 37° C., and consistent gas flow is maintained the enclosure. Colony forming units from microbial contamination detected by environmental monitoring within the enclosure are significantly reduced in this method.

Presently disclosed is a lighting system and methods of using the lighting system for in vitro potency assay for photofrin. The lighting system includes a lamp housing, a first lens, an infrared absorbing filter, an optical filter, and a second lens. The lamp housing includes a lamp and a light-port. In operation, broad spectrum light from the lamp exits the lamp housing by passing through the light-port. The first lens then collimates the broad spectrum light that exits the lamp housing through the light-port. The infrared absorbing filter then passes a first portion of the collimated broad spectrum light to the optical filter and absorbs infrared light of the broad spectrum light. The optical filter then passes a second portion of the collimated broad spectrum light to the second lens. The second lens then disperses the second portion of the collimated light to provide uniform irradiation of a cell culture plate. A method of using the lighting system for studying a photosensitizer is also disclosed.

Presently disclosed is a lighting system and methods of using the lighting system for in vitro potency assay for photofrin. The lighting system includes a lamp housing, a first lens, an infrared absorbing filter, an optical filter, and a second lens. The lamp housing includes a lamp and a light-port. In operation, broad spectrum light from the lamp exits the lamp housing by passing through the light-port. The first lens then collimates the broad spectrum light that exits the lamp housing through the light-port. The infrared absorbing filter then passes a first portion of the collimated broad spectrum light to the optical filter and absorbs infrared light of the broad spectrum light. The optical filter then passes a second portion of the collimated broad spectrum light to the second lens. The second lens then disperses the second portion of the collimated light to provide uniform irradiation of a cell culture plate. A method of using the lighting system for studying a photosensitizer is also disclosed.

The present invention provides a biological indicator for verification of disinfection or sterilization, and in particular, provides a biological indicator capable of verifying disinfection or sterilization using luminescent microorganisms, and a kit for verification of disinfection or sterilization using the biological indicator. According to the present invention, it is possible to provide a biological indicator for verification of disinfection or sterilization that may confirm in real time how much disinfection or sterilization has been performed after disinfecting or sterilizing harmful microorganisms by irradiation with UV rays.