Method for the validatable inactivation of pathogens in a biological fluid by irradiation
AssigneesBaxter International Inc., Baxter Healthcare S.A.
InventorsHeinz Anderle, Peter Matthiessen, Hans-Peter Schwarz, Peter Turecek, Thomas Kreil, Daniel R. Boggs
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Abstract
A validatable method for determining a photochemically effective dose for inactivating pathogens in a fluid sample is described herein. In particular, the instant invention covers methods for determining a photochemically effective dose sufficient to inactivate pathogens in a biological sample while leaving biologically active substances of interest unaffected. A batch irradiation reactor effective for inactivating pathogens in biological samples is also described.
Claims30
A method for inactivating microorganisms in a biological fluid, the method comprising:
- (a) determining a target light fluence effective to inactivate microorganisms in the biological fluid by:
- (i) irradiating a dosimetric solution for calibration with a known incident light fluence of light comprising a first wavelength in a layer of the dosimetric solution having an optical path-length sufficiently thin to absorb less than 80% of the incident light comprising the first wavelength, thereby effecting a chemical change in the dosimetric solution measurable by a change in absorbance of the dosimetric solution at a second wavelength,
- wherein the dosimetric solution matches the absorption coefficient of the biological fluid at the first wavelength, and further wherein the dosimetric solution is not a sample of the biologic fluid,
- (ii) measuring the change in absorbance of the dosimetric solution at the second wavelength,
- (iii) correlating the change in absorbance of the dosimetric solution to the known incident light fluence applied to the dosimetric solution to determine an effective light fluence applied to the dosimetric solution, and
- (iv) correlating the effective light fluence applied to the dosimetric solution to a target light fluence effective to inactivate microorganisms in the biological fluid to determine the target light fluence effective to inactivate microorganisms in the biological fluid upon irradiation in a photoinactivation reactor;
- and
- (b) irradiating the biological fluid in the photoinactivation reactor with the target light fluence of the light comprising the first wavelength.
A method for determining a target light fluence effective to inactivate microorganisms in a biological fluid, the method comprising:
- (a) irradiating a dosimetric solution for calibration with a known incident light fluence of light comprising a first wavelength in a layer of the dosimetric solution having an optical path-length sufficiently thin to absorb less than 80% of the incident light comprising the first wavelength, thereby effecting a chemical change in the dosimetric solution measurable by a change in absorbance of the dosimetric solution at a second wavelength,
- wherein the dosimetric solution matches the absorption coefficient of the biological fluid at the first wavelength, and further wherein the dosimetric solution is not a sample of the biologic fluid,
- (b) measuring the change in absorbance of the dosimetric solution at the second wavelength,
- (c) correlating the change in absorbance of the dosimetric solution to the known incident light fluence applied to the dosimetric solution to determine an effective light fluence applied to the dosimetric solution, and
- (d) correlating the effective light fluence applied to the dosimetric solution to a target light fluence effective to inactivate microorganisms in the biological fluid to determine the target light fluence effective to inactivate microorganisms in the biological fluid upon irradiation in a photoinactivation reactor.
Dependencies are inferred from the claim text.