Deep draw container forming method
The present disclosure is directed to processes for manufacturing shaped articles for unit-dose packaging with at least one formed recess (e.g., a blister), in particular for unit-dose packaging of pharmaceutical dosage forms. In certain embodiments, the first step of the process is directed to drawing the film material (e.g., metal-plastic foil) with one or more plungers to form a primary contour, the contour having a depth of at least 100% and up to 150% of the depth of the formed recess. The second stage involves shaping the primary contour with one or more plunger(s) to the desired formed recess, with a depth that is less than the depth of the primary contour, while substantially maintaining the surface area of the primary contour formed in the first stage. The formed recess may be formed using warm-forming or cold-forming techniques.
1. A process for manufacturing a shaped article for unit-dose packaging with at least one formed recess, which comprises:
(a) holding a film between at least one retaining tool and at least one die, wherein the die has at least one die opening;
(b) driving a first plunger into the die opening, which causes the film to be formed into a primary contour, the contour having a depth of at least about 100% and up to about 150% of the depth of the formed recess, and an Area Ratio of about 1.0 to about 3.0; and
(c) driving a second plunger into the primary contour to a depth that is less than the depth of the primary contour, wherein the second plunger forms a different geometric shape for the formed recess with substantially the same Area Ratio as the primary contour.
2. The process of claim 1 , wherein the film is a metal-plastic laminate.
3. The process of claim 1 , wherein the Area Ratio is about 2.0.
4. The process of claim 1 , wherein step (b) is performed using a warm-forming step.
5. The process of claim 1 , wherein step (b) is performed using a cold-forming step.
6. The process of claim 1 , wherein step (c) is performed using a warm-forming step.
7. The process of claim 1 , wherein step (c) is performed using a cold-forming step.
8. The process of claim 1 , wherein steps (b) and (c) are performed using a warm-forming process.
9. The process of claim 1 , wherein steps (b) and (c) are performed using a cold-forming process.
10. The process of claim 1 , wherein the second plunger is driven into the primary contour to a depth of up to 95% of the formed recess.
11. The process of claim 1 , wherein the second plunger redistributes the film which forms the different geometric shape for the formed recess.
12. The process of claim 1 , wherein the shaped article comprises one or more shaped blisters.
13. The process of claim 12 , wherein the shaped article comprises one or more multi-layer blisters with multiple chambers.
14. The process of claim 1 , wherein the shaped article comprises one or more stacked blisters with lidding.
15. The process of claim 1 , wherein the shaped article comprises two or more connected shaped blisters.
16. The process of claim 1 , further comprising placing a unit dose of a pharmaceutical dosage form in the packaging recess.
17. The process of claim 16 , wherein the pharmaceutical dosage form comprises one or more active ingredients.
18. The process of claim 17 , wherein the upper die plate comprises the first plunger and the second plunger.
19. The process of claim 17 , wherein the lower die plate comprises a primary forming chamber and a final forming chamber.
20. The process of claim 16 , wherein the pharmaceutical dosage form is in aqueous form.
21. The process of claim 1 , further comprising placing a fluid for dispensing in the packaging recess.
22. The process of claim 1 , wherein a foil lidding is sealed onto the shaped article.
23. The process of claim 1 , wherein the retaining tool is an upper die plate and the die is a lower die plate.
24. The process of claim 1 , wherein the first plunger comprises a high friction forming surface.
25. The process of claim 1 , wherein the second plunger comprises a low friction forming surface.
26. The process of claim 1 , wherein driving the first plunger into the film has a higher friction than driving the second plunger into the film.
27. The process of claim 1 , wherein the die has a plurality of spaced die openings.
28. The process of claim 1 , wherein the Area Ratio is from about 1.1 to about 3.
29. The process of claim 1 , wherein the Area Ratio is from about 1.5 to about 2.5.
30. The process of claim 1 , wherein step (b), step (c) or steps (b) and (c) further comprise warming the die by exogenous heat to a temperature above ambient and below the melting point of the film.
31. The process of claim 30 , wherein the die is warmed to a temperature between 35° C. and 95° C.