Modular aseptic production system

Patent metadata

Field	Value
Publication number	US-12043436-B2
Application number	US-202217896538-A
Country	US
Kind code	B2
Filing date	Aug 26, 2022
Priority date	Dec 11, 2017
Publication date	Jul 23, 2024
Grant date	Jul 23, 2024

Abstract

A modular production system including a plurality of production modules connected in a linear series to form a production tunnel, and collectively defining a production channel, and wherein at least one fluid inlet port defined along the production tunnel, said inlet port is in fluid communication with a pressurized fluid source, whereby influx of fluid from said fluid source through said fluid inlet port acts to maintain the fluid pressure within the production channel at a higher pressure than the atmospheric pressure outside of the production tunnel; and wherein one of said production modules positioned between said proximal-most and distal-most production modules comprises a depyrogenator and/or sterilization module, comprising a transparent tubular body, and an irradiation source positioned external to said transparent tubular body, said irradiation source capable of heating the internal environment of the depyrogenation and/or sterilization module to a temperature sufficient to depyrogenate or sterilize articles passing therethrough, and associated processes.

First claim

What is claimed is:

1. A process for producing at least one sterile container for material, comprising the steps of:
a) providing at least one container to be sterilized;
b) providing a modular production system comprising: an infeed module having a housing defining an entrance, an exit, and an internal cavity between said infeed housing entrance and infeed housing exit; a sterilization module comprising a transparent tubular housing defining an entrance and exit and an interior cavity extending between said sterilization module entrance and sterilization module exit; and an outfeed module having a housing defining an entrance, an exit and an internal cavity between said outfeed housing entrance and infeed housing exit; wherein the infeed housing exit is operatively connected to the transparent tubular housing entrance, and the transparent tubular housing exit is operatively connected the entrance of the outfeed module, whereby the interior cavities the infeed module, sterilization module and outfeed modules are operatively interconnected and together form a production tunnel;
wherein each of said infeed, sterilization, and outfeed modules comprises a transport system, comprising a drive mechanism, and an internal transport mechanism, which operatively engaged to said drive mechanism having a container support surface;

the at least one container and internal transport mechanism engage to transport the at least one container from a module's entrance to the module's exit, and allows transport of the at least one container from one module to the next, allowing passage of the at least one container from the infeed module entrance to the outfeed module exit;
wherein the production system further comprises: a pressurized fluid source, operatively connected to the production tunnel, said fluid source providing pressurized air or other gas or gas mixture to maintain atmospheric pressure within the production tunnel of the production system at a level which exceeds the ambient atmospheric pressure within which the production system is housed; and
wherein said sterilization module further comprises; an irradiation source which is positioned to irradiate the transparent tubular housing to a sterilization temperature;

c) positioning the at least one container for material in operational engagement with the internal support surface of the internal transport system of the infeed module, and within the greater atmospheric pressure therein, and transporting the at least one container through the infeed module internal cavity along the production tunnel and into the internal cavity of the transparent tubular housing;
d) irradiating the at least one container within the interior cavity of the transparent tubular housing at a time and temperature sufficient to sterilize the at least one container; and
e) transporting the sterilized at least one container to the container support surface of the internal transportation mechanism extending through the internal cavity of the outfeed module.

2. The process of claim 1 , wherein the process further comprises:
providing at least one cooling module, said at least one cooling module each comprising:
a housing, said housing having defined therein an entrance port, an exit port, and an internal cavity extending between said cooling module housing entrance and exit ports;
a transport system, comprising a drive mechanism, and an internal support surface which operatively engages a container within the cooling module which permits transport of the at least one container from the cooling module's entrance port to its exit port; and
a cold air source, for providing cold air, said cold air source operatively connected to the interior cavity of the cooling module, said cold air, emerging from the cold air source acts to maintain the temperature of the cooling module internal cavity below that of the internal temperature of the internal cavity of the sterilization module;
wherein each of said at least one cooling module is positioned between said sterilization module exit, and the entrance of the outfeed module, the internal cavity of one of the at least one cooling module defines a portion of the production tunnel of the production system;

and further includes between steps d and e the step of:
transporting the sterilized at least one container from the sterilization module to the interior cavity of said cooling module, allow said sterilized at least one container to be exposed to the cold air within the cooling module interior cavity to reduce the temperature of the sterilized at least one container to a desired temperature, to generate at least one sterilized and cooled container.

3. The process of claim 2 , further comprising the steps of:
providing a filling module positioned between the at least one cooling module and the outfeed module, said filling module comprising a housing having an entrance, and an exit, and a central cavity extending there between, and a filling mechanism for delivering a material to the cooled container, and a transport system, comprising a drive mechanism, and an internal transport mechanism positioned within the filling module central cavity, said internal transport mechanism comprising a container support surface; said internal transport mechanism operatively engaged with said drive mechanism; the at least one container and internal transport mechanism engage to transport the at least one container from the filling module's entrance to its exit which facilitates transport of the at least one container from one module to the next, allowing passage of the at least one container from the infeed module entrance to the outfeed module exit; and
transporting the sterilized and cooled at least one container to the filling module and delivering a material from the filling mechanism to the at least one container to generate at least one filled container.

4. The process of claim 3 , wherein the production tunnel further comprises: a closure module comprising a closure mechanism for sealing a container, and the process further includes the steps of:
transporting the at least one filled container to the closure module, and
sealing the at least one filled container with a closure to generate at least one filled sealed container.

5. The process of claim 4 , wherein the closure is a cap compressed into an opening in the at least one container.

6. The process of claim 4 , wherein the closure is a seal over an opening of the at least one container.

7. The process of claim 4 , wherein the closure is a crimp around or of a portion of the at least one container.

8. The process of claim 4 , further comprising; the step of transporting the sterilized, filled and sealed at least one container to the outfeed module.

9. The process of claim 8 , further comprising; the step of offloading the sterilized, filled and sealed at least one container from the exit port of the outfeed module.

10. The process of claim 1 , wherein the drive mechanism of the infeed module, the sterilization module, and the outfeed module are external to the production tunnel and comprise at least one drive magnet, and the internal transport mechanism of each of said modules comprise at least one follower magnet, wherein said drive magnet and said follower magnet are magnetically coupled, such that movement of the drive magnet causes movement of the follower magnet, and results in movement of the at least one container by internal transport system.

11. The process of claim 3 , wherein the filling mechanism is adapted to deposit a material into a container.

12. The process of claim 11 , wherein the material is a fluid.

13. The process of claim 12 , whe

Assignees

• Glaxosmithkline Ip Dev Ltd

Inventors

• Sanmartin Francesco

Classifications

• A61L2103/05

  Living organisms or biological materials · CPC title

• B65B55/025

  Packaging in aseptic tunnels · CPC title

• B65B43/42

  Feeding or positioning bags, boxes, or cartons in the distended, opened, or set-up state; Feeding preformed rigid containers, e.g. tins, capsules, glass tubes, glasses, to the packaging position; Locating containers or receptacles at the filling position (by means of filling-nozzles B65B39/00); Supporting containers or receptacles during the filling operation (by filling-nozzles B65B39/00) · CPC title

• B65B7/2821

  applying plugs or threadless stoppers (for bottles or jars B67B1/04) · CPC title

• B65B3/003

  Filling medical containers such as ampoules, vials, syringes or the like · CPC title