Cold blow-fill-seal packaging system and process

1. A method for blow-fill-seal packaging in a blow-fill-seal machine of a heat sensitive product that is subject to denaturing and/or precipitation in the event that the product becomes too warm, said method comprising steps of:

forming a container to provide a formed container in a mold of the blow-fill-seal machine;

cooling the formed container to a container temperature between 60° C. to 80° C., said cooling step consisting of waiting a duration of from more than one second to about 5 seconds from when the container is formed,

filling the formed container with the product after the cooling step, and wherein the container is at a temperature between 60° C. to 80° C. at the start of the filling step and the product employed in the filling step has a temperature between about 0° C. to about 20° C. and immediately after filling the formed container, has a temperature no greater than 40° C.; and

sealing the container;

wherein the blow-fill-seal (BFS) packaging is a packaging in which in a sterile and pyrogen-free state, formation of a container by blowing an extruded resin, filling of a product in the formed container and sealing of the container are carried out by means of a single mold.

2. The method of claim 1 , wherein the product is passed through a heat-exchanger prior to said filling step.

3. The method of claim 2 , wherein the heat exchanger is a counter-current heat exchanger.

4. The method of claim 1 , wherein the waiting step has a duration of from about 2 to about 5 seconds from when the container is formed.

5. The method of claim 1 , wherein the product, immediately after filling the formed container, has a temperature of about 40° C.

6. The method of claim 1 , wherein the product, immediately after filling the formed container, has a temperature of less than about 40° C.

7. The method of claim 1 , wherein the product, immediately after filling the formed container, has a temperature of less than about 38° C.

8. The method of claim 1 , wherein the product, immediately after filling the formed container, has a temperature of less than about 36° C.

9. The method of claim 1 , wherein a resin melt parison used to form the container is extruded at a temperature of between about 160° C. to 180° C.

10. The method of claim 9 , wherein a flash formed when the mold closes around the parison is at a temperature between about 120° C. to 140° C.

11. A system for cold blow-fill-seal packaging of a heat sensitive product that is subject to denaturing and/or precipitation in the event that the product becomes too warm, said system comprising:

a holding tank for holding the heat sensitive product that is subject to denaturing and/or precipitation in the event that the product becomes too warm; and

a blow-fill-seal machine adapted to:

(a) form a container in a mold of the blow fill seal machine to provide a formed container in the mold;

(b) cool the formed container in the mold to a temperature between 60° C. to 80° C., by a cooling step consisting of waiting for more than one second to about five seconds once the container is formed, and

(c) fill the heat sensitive product into the formed container having the temperature between 60° C. to 80° C. in the mold after cooling the formed container to the temperature between 60° C. to 80° C., and wherein the product, immediately after filling has a temperature no greater than 40° C.; and

(d) seal the container;

wherein the blow-fill-seal (BFS) machine is a machine in which in a sterile and pyrogen-free state, formation of the container by blowing an extruded resin, filling of the product in the formed container and sealing of the container are carried out by means of a single mold.

12. The system of claim 11 , further comprising a buffer tank located between the holding tank and the blow-fill-seal machine and fluidly connected to the flow line.

13. The system of claim 11 , wherein the heat exchanger is a counter-flow heat exchanger.

14. The system of claim 11 , wherein the flow line is insulated.