Method for preparing a blood product container

Abstract

To solve the problem in which although, in the sector concerned with preparation of blood-derived product containers, a quality control test is carried out thereon to detect possible defects in the container, yet visual inspection of the containers is not sufficient as it is difficult to detect defects, which means that many containers arrive at end users in poor condition.SOLUTION: A method of preparing containers for blood-derived products at least includes: filling the blood-derived product containers with the blood-derived product; virally inactivating the blood-derived product containers; and controlling the quality for detecting possible defects in the blood-derived product containers. The viral inactivation is carried out by placing the blood-derived product containers in contact with steam at sub-atmospheric pressure in a chamber adapted for that purpose.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present application discloses a method for preparing a container for a blood product that has novel properties that are advantageous compared to known properties. [Background technology]

[0002] One of the methods for inactivating viruses known in the prior art for the field of technology related to blood products consists of heat treatment by submerging a container or bag of the product in water. The water is heated until the product reaches a target temperature, which depends on the requirements of the blood product, and from that time begins a circulation that inactivates the viruses using a water bath. During this circulation, which lasts for a number of hours, the temperature must be maintained within a very limited range. Once the circulation is complete, the product is quickly cooled again to prevent excessive exposure of the product to high temperatures.

[0003] In the field of blood product container preparation, quality control tests are performed on the containers to detect potential defects within them. However, visual inspection of the containers is not sufficient because it is difficult to detect defects, meaning that many containers reach the end user in an insufficient state. In many cases, the containers, which may be bags made of plastic materials, have defective sealing operations that cannot be detected with the naked eye due to defects such as defective welds in the container, breaks, ruptures, and holes in the container wall, and other types of defects that cannot be seen with the naked eye. The defects sometimes become apparent when the containers are already available to consumers. Summary of the Invention [Problem to be solved by the invention]

[0004] The present invention aims to overcome this drawback by subjecting the container to a challenge test during the process of inactivating viruses in the product in order to amplify defects in the container so as to facilitate the detection of defects in the process of visually inspecting the product for quality control. The challenge test has the additional advantage of replacing previously used virus inactivation methods in the field of blood products.

[0005] The objective of the present invention is to achieve more effective and simpler quality control while also replacing conventional methods of virus inactivation of blood product containers.

[0006] The present invention discloses a method for simultaneously inactivating and challenge testing blood product containers for viruses, and aims to overcome some of the drawbacks found in the prior art. [Means for solving the problem]

[0007] More specifically, the present invention discloses a method for preparing a container for a blood product, comprising: - filling the blood product container with the blood product; - virus inactivation of blood product containers; - a quality control process to detect potential defects in blood product containers; wherein the step of inactivating viruses is carried out by contacting the blood product container with steam at subatmospheric pressure in a chamber adapted for the purpose.

[0008] Preferably, the method includes an additional cooling step after the step of inactivating viruses in the blood product container. More preferably, the cooling step is performed by recirculating chilled air.

[0009] More preferably, in the virus inactivation step, the steam is "sterile", in other words, the steam is free of contaminating particles. Even more preferably, the steam used in the virus inactivation step is steam of sanitary quality. Contaminating particles found in the steam may be rust, scale, dust and deposits that may be caused by the water used to generate the steam. Sanitary quality steam is understood as steam produced from sanitary quality water, the parameters and parameter values ​​of which meet those established by the World Health Organization in the guidelines for drinking water quality.

[0010] More preferably, the steam used in the virus inactivation step is saturated steam. Alternatively, superheated steam may be used.

[0011] Preferably, the quality control step includes visual inspection of the blood product containers to detect defects in the containers. More preferably, the purpose of said visual inspection is to detect containers with defective sealing operations.

[0012] More preferably, the blood product is albumin and the virus inactivation step is carried out at a temperature between 55°C and 65°C and an absolute pressure between 190mbar and 210mbar. Even more preferably, the blood product is albumin and the virus inactivation step is carried out at a temperature between 59.5°C and 60.5°C and an absolute pressure of 200mbar. When the blood product is albumin, the virus inactivation step preferably lasts for 10 to 11 hours.

[0013] Alternatively, the blood product is Factor VIII and the step of inactivating the virus is carried out at a temperature between 80°C and 82°C and at an absolute pressure between 450 mbar and 550 mbar.

[0014] These pressure and temperature conditions in the virus inactivation process cause the steam to be in a gaseous state.

[0015] Preferably, the container is a bag made of a plastic material. Alternatively, the container is a vial. In an alternative, the container is made of any other material that allows the blood product contained therein to meet health standards in this respect.

[0016] For a better understanding, the accompanying drawings of embodiments of the invention are provided as illustrative but non-limiting examples. [Brief explanation of the drawings]

[0017] [Figure 1] 1 illustrates the steps of the method according to the invention; DETAILED DESCRIPTION OF THE INVENTION

[0018] FIG. 1 shows step 1 of filling the container with blood product, a second virus inactivation step 2 with a steam connection inlet 2' at sub-atmospheric pressure, and a third quality control step 3 followed by storage 4. [Example]

[0019] In a first embodiment according to the method of the examples, the method for preparing a blood product container uses albumin as the product. In filling step 1, the container is filled. In this embodiment, the container is preferably a bag made of a plastic material. In virus inactivation step 2, virus inactivation is carried out using steam at subatmospheric pressure in direct contact with the bag made of a plastic material. The step is carried out at a temperature between 55°C and 65°C and an absolute pressure between 190 mbar and 210 mbar. In a more preferred embodiment, the step is carried out at a temperature between 59.5°C and 60.5°C and an absolute pressure of 200 mbar.

[0020] During the virus inactivation step 2, the bag is subjected to the temperature and pressure conditions described above for a sustained period of 10 to 11 hours. The sustained period under these temperature and pressure conditions constitutes a stress test and a seal test of the bag, which exacerbates small existing defects. If the bag has defects, the steam used has the ability to penetrate the bag, and the penetration is easily visible to the naked eye, simplifying visual detection of the defects.

[0021] Next, a step of cooling the bag made of plastic material is carried out. The cooling step is an air cooling step. In addition, it is desirable to incorporate an air venting device. Preferably, the air is filtered through a sterilizing filter.

[0022] Finally, quality control step 3 involves visual inspection, where, among other things, the container is inspected for sealing defects, such as defects in the welding of the container, cracks, ruptures, and holes in the container wall, and other types of defects.

[0023] The objective of quality control is to discard defective containers. To do this, means of artificial observation and image processing may be used, for example. According to the present invention, defects may be detected by detecting water in the container.

[0024] Alternatively, in this first embodiment, a glass container may be used.

[0025] In a second embodiment according to the method of the examples, the method for preparing a blood product container uses Factor VIII as the product. In filling step 1, the container is filled. In this embodiment, the container is usually a vial. Alternatively, the container may be another type of container. After filling, the product is freeze-dried, and after said freeze-drying, virus inactivation step 2 is carried out. In virus inactivation step 2, virus inactivation is carried out by direct contact of steam with a bag made of a plastic material under subatmospheric pressure. The step is carried out at a temperature between 80°C and 82°C and an absolute pressure between 450 mbar and 550 mbar.

[0026] During the virus inactivation step 2, the bag is subjected to the temperature and pressure conditions mentioned above for a duration of 72 to 74 hours. The duration at these temperature and pressure conditions represents a stress test and a seal test of the bag that exacerbates small existing defects. If the bag has defects, the steam used has the ability to penetrate the bag, and the penetration is easily visible to the naked eye, making visual detection of the defects easy.

[0027] The vials are then cooled. This cooling step is an air cooling step. In addition, it is desirable to incorporate an air vent. Preferably, the air is filtered through a sterilizing filter.

[0028] Finally, quality control step 3 involves visual inspection, where, among other things, sealing defects are checked, such as defects in welding the container, breaks, ruptures, and holes in the container wall, and other types of defects.

[0029] The objective of quality control is to discard defective containers. To do this, methods of artificial observation and image processing may be used, for example. According to the present invention, defects may be detected by detecting water in the container.

[0030] Various tests were performed using non-defective bags and defective control bags, showing that for the defective bags, steam penetrated them and for the non-defective bags, steam did not penetrate, demonstrating the feasibility of the method described in this application, both for inactivating viruses and for detecting defects.

[0031] Although the present invention has been described and illustrated on the basis of various representative examples, it is understood that said embodiments, given by way of example, do not in any way limit the invention, and therefore all variations which are included directly or as equivalents in the content of the appended claims should be considered to be included within the scope of the invention. [Explanation of symbols]

[0032] 1: The process of filling containers with blood products 2: Virus inactivation process 2': Steam connection inlet at subatmospheric pressure 3: Quality control process 4: Storage

Claims

1. 1. A method of preparing a container for a blood product, comprising: filling the blood product container with the blood product; inactivating viruses in the blood product container; wherein the step of inactivating viruses is carried out by contacting the blood product container with steam at sub-atmospheric pressure in a chamber adapted for the purpose, and is carried out simultaneously with a challenge test so as to facilitate the detection of defects in the quality control process; the step of inactivating viruses is followed by a step of quality control for detecting defects visible to the naked eye in a container of the blood product, the step of quality control including a visual inspection of the container to detect defects in the container; The blood product is medical albumin, and the virus inactivation step is carried out at a temperature between 55°C and 65°C, at an absolute pressure of 190 mbar to 210 mbar, for 10 to 11 hours; or A method wherein the blood product is Factor VIII and the step of inactivating viruses is carried out at a temperature between 80°C and 82°C, at an absolute pressure of 450 mbar to 550 mbar, for 72 to 74 hours.

2. 10. The method of claim 1, further comprising the step of cooling the blood product container after the step of inactivating viruses.

3. 3. The method of claim 2, wherein the cooling step is carried out by contacting the blood product container with purified water.

4. 10. The method of claim 1, wherein the steam used in the virus inactivation step is sanitary quality steam.

5. 10. The method of claim 1, wherein the steam used in the virus inactivation step is saturated steam.

6. 2. The method of claim 1, wherein the blood product is medical grade albumin and the step of inactivating viruses is carried out at a temperature between 59.5°C and 60.5°C and an absolute pressure of 200 mbar.

7. The method of claim 1 , wherein the container is a bag made of a plastic material.

8. The method of claim 1 , wherein the container is a vial.

Images