PRESSURE STABILIZER

Abstract

Herein is described a pressure resistant shell for stabilizing a welding seam of a weldable tubing as well as a method of using it.

Claims

1. A pressure resistant shell for stabilizing a welding seam of a weldable tubing, wherein a) the pressures resistant shell comprises either at least two components wherein one component comprises a groove and the other an elevation which fits the groove wherein one of said at least two components is manufactured from plastic or glass or b) the pressure resistant shell comprises at least one BarbLock® that secures a welding seam of a weldable tubing.

2. The shell according to claim 1 wherein the weldable tubing is an aseptically weldable tubing.

3. The shell according to claim 1 wherein the weldable tubing and/or an aseptically weldable tubing is used at a pressure of between 0-5 bar, optionally 2,5-3,5 bar, optionally 2,8 bar.

4. The shell according to claim 1 wherein the weldable tubing and/or an aseptically weldable tubing further comprising at least one spring encasing 90-100% of the tubing when the spring is relaxed and 50-95% of the tubing when the spring is compressed.

5. The pressure resistant shell according to claim 1, wherein a) the pressure resistant shell comprises at least two components wherein one component comprises a groove and the other an elevation which fits the groove.

6. The pressure resistant shell according to claim 1, wherein the pressure resistant shell comprises at least two components wherein one component comprises a groove and the other an elevation which fits the groove wherein one of said at least two components is manufactured from plastic or glass.

7. The pressure resistant shell for use according to claim 1, wherein the pressure resistant shell comprises at least one BarbLock® device that secures a welding seam of a weldable tubing.

8. A system for continuous production of a protein of interest wherein the system is a production system that comprises at least one aseptically weldable tubing and a product comprising at least one pressure resistant shell according to claim 1.

9. A method for using a production system according to claim 8, wherein during assembly of the production system at least one spring is placed onto a weldable tubing which is to be welded aseptically during production of the protein of interest.

Description

FIGURES

[0059] FIG. 1 shows a schematic drawing of a pressure resistant shell (1) in this example consisting of a first component comprising a groove (2) and a second component comprising an elevation that fits the groove (3) and the two components are spatially fixed in relation to an aseptically weldable tubing (not shown) via two cable ties (4).

[0060] FIG. 2 shows a schematic drawing of a weldable tubing (8)—here a Masterflex BPT LS24—to be welded aseptically. In this case the tubing needs to be welded aseptically, since the filter (5) is to be replaced during the continuous production of a protein of interest under pathogen reduced conditions i.e. the closed state has to be maintained. Thus, in preparation for the aseptical welding springs (9) positioned adjacent to the filter (5) are compressed and fixed in the compressed state by hose clamps (6) thereby exposing the part of the weldable tubing to be welded aseptically. It should be noted that also right and left of the filter springs (9) are present, which are not shown in FIG. 2, but which are shown in FIG. 3. Connecting pieces (7)—here tube connectors secured with barblock retainers—link the weldable tubing to a non-weldable tubing (11) in this example a braided hose.

[0061] FIG. 3 shows a schematic drawing of the setting of FIG. 2 one step further during the process of aseptic welding. In detail the weldable tubing (8) is sealed off and cut at two positions (10) right and left of the filter (5) and exchanged for a new piece of tubing (8.1) comprising a new filter (5.1), new springs 9.1 right and left of the filter and two new hose clamps (6.1) using a Biowelder TC.

[0062] FIG. 4 shows a schematic drawing of the settings of FIGS. 2 and 3 after the aseptic welding process has been completed. In detail, the new filter (5.1) is in place, welding seams (12) connecting the new weldable tubing (8.1) with the weldable tubing (8) are secured with pressure resistant shells (1). The springs (9) and (9.1) respectively, cover and thereby secure the new weldable tubing (8.1) and the weldable tubing (8).

[0063] FIG. 5 depicts a schematic drawing of a BarbLock® of Saint-Gobain performance Plastic. In detail FIG. 5a) depicts the two components “sleeve” and “collet” whereas FIG. 5b) shows how the sleeve and the collet of the BarbLock® are used to secure a welded seam (12).

[0064] FIG. 6 depicts a schematic drawing of a fluid filled, pathogen reduced, closed and ideally bubble free chromatography assembly (13) after aseptic welding. In detail the chromatography column (15) was exchanged via aseptic welding (pressure resistant shells, spring and welding seams not shown) after securing the fluid filled part of the chromatography assembly with pinch valves (16). The pinch valves ensured that no fluid left the system and no gas bubbles entered the system. Following aseptic welding of tubing (8) and prior to removing the pinch valves (16) the bypass path (14) was flushed to remove gas bubbles resulting in a fluid filled, pathogen reduced, closed and ideally bubble free chromatography assembly.