TERMINAL STERILIZATION OF BIOLOGICS

Abstract

The invention involves the use of supercritical or near supercritical fluids to inactivate pathogens in biologic materials which may or may not be contaminated by pathogens. The pathogen reduced material is then inserted into empty, sterile containment vessels. The apparatus can be used as a means to achieve terminal sterilization of the biologic materials. The preferred method of use for the apparatus includes operation of a conveyor belt to move and fill bottles, flasks, containers, or vials in an assembly line to create the finished product in an effective and timely fashion.

Claims

1. An apparatus for delivering a material in a terminal containment vessel comprising: (a) a first conduit for conveying a first fluid stream having a material for placing in a containment vessel; (b) a second conduit for conveying a second fluid stream having a supercritical, critical or near critical fluid; (c) a third conduit in communication with said first conduit and said second conduit for forming an admixture fluid of said first fluid and second fluid under super critical, critical, or near critical conditions; and (d) a delivery means for placing said admixture into said containment vessel.

2. The apparatus of claim 1 wherein said delivery means comprises a nozzle, said delivery means includes a backpressure regulator, and said third conduit comprises an in-line mixer.

3. A method of inactivating pathogens potentially associated with a fluid containing a material to be placed in a terminal containment vessel comprising the steps of: (a) producing a first fluid stream of said product fluid; (b) providing a second fluid stream of a supercritical, critical or near critical fluid; (c) forming an admixture fluid of said first fluid and second fluid under supercritical, critical or near critical fluid; and (d) directing said admixture into said terminal containment vessel to deposit said materials in said containment vessel as said supercritical, critical, or near critical fluid is vested to leave a material that is pathogen free.

4. A method of claim 3 for depositing said admixture in containment vessel comprising of the use of a nozzle.

5. A method of claim 3 for conveying the vials comprising of (a) a conveyor belt, turntables, endless belts, slide surfaces; (b) a vial conveying means is enclosed to maintain sterility; (c) a laminar hood or vacuum to achieve enclosure; and (d) an enclosed vial conveying means that includes an aperture to release gases of admixture,

6. A method of claim 3 or sealing the containment vessels by placing covers or lids on top of containment vessels.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 depicts an apparatus having features of the present invention.

DETAILED DESCRIPTION

[0013] Embodiments of the present invention will be described in detail as a method or apparatus for inactivating pathogens. This detailed description is directed to the best mode or modes to practice the invention as presently contemplated. The methods and apparatus of the present invention feature two in-line streams; one consisting of product fluid and the other consisting of supercritical, near critical or critical fluids.

[0014] FIG. 1 illustrates a preferred apparatus for inactivating the pathogens through the means of the two-inline streams combining in a third conduit.

[0015] The preferred apparatus includes the two in-line fluids combining in a third conduit, where the mixing and extraction process is conducted. The first in-line material solution (1) is combined with the second in-line supercritical fluids (2), in a mixing device, referred to as the third conduit (3). The supercritical fluids work to extract pathogens from the solution or substance (4). Post-extraction the materials are inserted into terminal containment vessels (5) where the material is eventually stored therein (6). This may be done on a conveyer belt, as a preferred apparatus, but is not limited to such an apparatus (7). A backpressure regulator is also included in the apparatus (8). A nozzle (9) for inserting said mixture into containment vessel by means of the belt. To ensure maximum sterilization the containment vessels and belt are enclosed in a device such as a laminar hood or vacuum (11). The enclosed vacuum or hood should also include an aperture to release gases of the admixture (12).

[0016] Embodiments of the present method and apparatus are ideally suited for biological materials that need be free of microbes and pathogens. The invention will inactivate microbes and pathogens through the use of the supercritical fluid expansion process by combining the biological material with the solvent. The embodiments of the invention will cause the biological material to be separated from the microbes and pathogens, rendering the biological material free of the microbes and pathogens. Thereby, rendering the biological material sterile and ultimately terminally sterile.

[0017] A particular super critical, critical, or near critical fluid will be selected based upon at least two factors. First, the fluid should be capable of achieving the desired result of inactivating viruses. Secondly, the fluid should be selected with the goal of minimally affecting the material being treated. For example, in the case of a protein, a fluid with an operating temperature below 60° C., that does not chemically denature or otherwise adversely affect the material is preferred.

[0018] The particular fluid selected as well as the time of exposure of the critical fluid to the material, the temperature and pressure of the mixture are interdependent and together or individually may determine the appropriate conditions for the desired result. Namely, the time the critical fluid is exposed to the material may affect the degree of the pathogen inactivation. Therefore, the conditions for treating the material include sufficient time exposure to ensure that the material has the desired pathogen reduction or complete eradication of the pathogen post-treatment.

[0019] Preferably, the first in-line fluid (material) is separated from the second in-line fluid (critical fluid) in the third conduit under aseptic conditions. If for example, a solution containing a protein to achieve separation, the mixture is decompressed thereby resulting in a phase separation of the fluid from the solution containing the proteinaceous product. The material then is isolated under aseptic conditions.

[0020] Isolating the material refers to separating the material from the equipment of the invention such as in a sterile bottle, flask, container or vial. It does not simply mean separating the material from the critical fluid into a compartment or container that is part of the sterilization equipment of the invention. Nevertheless, it should be understood that the terminal containment vessel used in isolating the material may be at least temporarily attachable to the equipment of the invention so as to facilitate in the transfer of the material from the apparatus to its isolated state in the terminal containment vessel.

[0021] Embodiments of the present apparatus are ideally suited for inactivating pathogens that is associated with biological materials. The supercritical, critical or near critical fluid is selected to have minimal effects on the material aside from the eradication of pathogens.

[0022] The preferred apparatus includes a source of fluid, a high pressure, recirculation loop, a separation chamber, and at least one low-pressure trap. Viral inactivation occurs in the high-pressure, recirculation loop, which is rated for continuous operation at 5,000 prig and 100° C.

[0023] Thus, the inventions have been described in detail with respect to the best mode. Those skilled in the art will readily understand that the description is capable of modification and alteration without departing from the teaching herein. Therefore, the invention should not be limited to the precise details presented but should encompass the subject matter of the claims that follow and their equivalents.