Chemical apparatus and process disinfecting – deodorizing – preser – Chemical reactor – With means applying electromagnetic wave energy or...
Reexamination Certificate
2001-01-12
2003-04-01
Mayekar, K. (Department: 1741)
Chemical apparatus and process disinfecting, deodorizing, preser
Chemical reactor
With means applying electromagnetic wave energy or...
C422S024000
Reexamination Certificate
active
06540967
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to an apparatus for the irradiation, in particular the UV irradiation, of a liquid. The irradiation in this case takes place under precisely defined conditions. The apparatus according to the invention is therefore suitable in particular for the inactivation of viruses and other pathogens in biological liquids, in particular in blood serums.
It is known to irradiate biological liquids with intensive ultraviolet light for the inactivation of viruses and other pathogens. Other methods are, for example, gamma irradiation and microwave treatment. The rate of absorption of serums and other biological liquids is several orders of magnitude greater than that of normal water, which is often likewise irradiated with UV light for removing bacteria. On account of the high rate of absorption, the serums are irradiated in the form of a thin layer, in order to ensure full inactivation. The layer thickness of the serums during the UV irradiation is generally of an order of magnitude below 0.5 mm. Furthermore, the spectrum of the UV light radiated in is modulated in such a way that protein damage is avoided.
A device for carrying out the described treatment of serums was described back in 1947 (Habel, Sockrider, Journal of Immunology 56 (1947) 273-279). This concerns a rotating cylinder inclined slightly with respect to the horizontal. The liquid to be irradiated is applied to the inner side of the rotating cylinder. It is then pressed by the centrifugal force against the inside wall in the form of the required thin layer. On account of the inclination of the cylinder, the liquid is slowly passed through the cylinder and leaves it after approximately 8 seconds. One or more UV lamps are fixedly arranged along the axes of the rotating cylinder.
In another type of device, in the end individual parts by volume of the liquid in the form of a thin layer are exposed to the UV light, cf. U.S. Pat. No. 5,133,932. In this case it cannot be ensure at the irradiation will cover all parts by volume and consequently completely kill off the viruses in the liquid.
In the case of another type of device, the liquid is passed through thin capillaries coiled around the UV lamp, cf. U.S. Pat. No. 4,748,120. Capillary diameters of less than 1 mm are used in this case. However, only a low throughput is achieved as a result.
Taking these points into consideration, today devices of the first-mentioned category are frequently used for the inactivation of viruses and other pathogens in biological liquids, i.e. devices which are based on the publication by Habel et al. from 1947. U.S. Pat. No. 5,567,616 likewise discloses an apparatus which essentially corresponds in its construction to the principle of the device described back in 1947.
However, when this type of device, with a rotating inclined cylinder, has been used, it has repeatedly been the case that not all the viruses are killed off, on account of defective operating conditions. In these cases, considerable amounts of possibly defectively treated blood preparations had to be subsequently withdrawn, without however establishing sufficient certainty as to the cause and extent of the defective irradiation.
It is therefore the object of the present invention to provide an apparatus for the irradiation of liquids, in particular biological liquids, such as serums, which has safety devices for the avoidance or early detection of improper irradiation.
SUMMARY OF THE INVENTION
This object is achieved by the apparatus according to the invention. This apparatus for the irradiation of a liquid under defined conditions has a rotating cylinder with an upper inflow, a lower outflow and an irradiation unit, the cylinder forming an angle of inclination (&agr;) with the horizontal. The inclined cylinder rotates about its own axis. The liquid to be irradiated is introduced into the upper inflow. The introduced liquid is pressed by the centrifugal force against the inside wall of the cylinder, where it forms the required thin layer. A plurality of UV lamps for the irradiation of the liquid layer are fitted along the axis of the cylinder, ensuring intensive irradiation of the liquid. For the inactivation of the viruses and pathogens in biological liquids, such as in blood serums for example, light, in particular UVC light, is used. Light at a wavelength of 254 nm is preferably used for this. Irradiation at this wavelength leads on the one hand to relatively low protein damage and also, however, on the other hand to effective virus inactivation. In addition, mercury lamps which radiate the same wavelength can also be used for this purpose. Furthermore, laser light can also be used.
According to the invention, the lower outflow has two connections for passing on the liquid, one connection being closable with the aid of a first control unit if the irradiation of the liquid deviates from the defined conditions. In this case, the liquid can only pass the second connection, i.e. the unclosable connection. Consequently, once the first connection has been closed, that is after a problem has arisen with the irradiation, the liquid can be diverted into another container, that is to say be collected separately from the amount of liquid already irradiated under normal conditions. Correctly and possibly incorrectly irradiated amounts of liquid are consequently separated, so that any contamination of reliably irradiated serum with viruses is ruled out.
In a preferred embodiment, a second control unit is provided; which switches off the irradiation unit and/or interrupts the upper inflow if the irradiation deviates from the defined conditions.
Furthermore, in a further preferred embodiment, the apparatus according to the invention has a monitoring and documentation unit for at least one, preferably all, of the following parameters:
a) intensity of the irradiation,
b) rotational speed of the cylinder,
c) angle of inclination (&agr;) of the cylinder,
d) temperature of the liquid before and after the irradiation,
e) layer thickness of the liquid within the cylinder,
f) flow rate of the liquid through the cylinder.
These parameters are measured and documented at time intervals which can be freely set, whereby a chronologically complete documentation of the operating state is obtained. These operating data are preferably logged twice, to be specific both on a printer and on a storage medium, for example an exchangeable hard disk or a zip drive, which can be sealed and the tape of which can be exchanged at fixed intervals. The storage medium is required to ensure parameter storage in the event of failure of the printer. Furthermore, the recording on the storage medium may serve as forgery proof evidence of the operating conditions which is accessible only to selected persons, for instance the device manufacturer. Furthermore, the permanent storage on a data medium may also serve the purpose of providing the user with a statistical overview of his parameters. This achieves the effect that the respective operating conditions can be reconstructed later at any time and for a particular batch.
The monitoring and documentation unit according to the invention is preferably coupled to the first control unit and, if there is one, also to the second control unit in such a way that, if one or more of the parameters falls below a given minimum value or exceeds a given maximum value, the first control unit closes the closable connection of the lower outflow and the second control unit switches off the irradiation unit. If, for example, the lamps are too weak or fail entirely, the irradiation is automatically interrupted. At the same time, the inflow of the liquid into the rotating cylinder is ended. Furthermore, the closable connection at the lower outflow is closed by the first control unit, so that the remaining liquid located in the cylinder at this point in time is diverted through the second connection at the lower outflow into a separate container. Contamination of the already irradiated amount of liquid is avoided as a result. The second connection is preferably
Heith Johann
Mausbach Klaus
Hood Jeffrey C.
Mayekar K.
Meyertons Hood Kivlin Kowert & Goetzel P.C.
Pathogenex GmbH
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