Vial stopper for a lyophilization vial and closure method for closing a lyophilization vial

Patent metadata

Field	Value
Publication number	US-11577893-B2
Application number	US-202016831161-A
Country	US
Kind code	B2
Filing date	Mar 26, 2020
Priority date	Sep 28, 2017
Publication date	Feb 14, 2023
Grant date	Feb 14, 2023

Abstract

A vial stopper for closure of a lyophilization vial is disclosed. The vial stopper has a stopper body comprising a first circumferential sealing surface for hermetically sealing against an interior surface of a mouth of the vial in a first position of the vial stopper. The stopper body further comprises a second circumferential sealing surface for hermetically sealing against the interior surface of the mouth of the vial in a second position of the vial stopper. The second sealing surface is spaced apart from the first sealing surface in an axial direction of the stopper body. The stopper body further comprises an intermediate region in between the first and second sealing surfaces, the intermediate region having at least one venting element for venting an interior of the vial in at least one intermediate position of the stopper in between the first and second positions.

First claim

What is claimed is:

1. A vial stopper for closure of a lyophilization vial, the vial stopper having a stopper body, the stopper body comprising:
a first circumferential sealing surface configured for hermetically sealing against an interior surface of a mouth of the vial in a first position of the vial stopper;
a second circumferential sealing surface for hermetically sealing against the interior surface of the mouth of the vial in a second position of the vial stopper, the second sealing surface being spaced apart from the first sealing surface in an axial direction of the stopper body; and
an intermediate region axially positioned between the first and second sealing surfaces, the intermediate region having a vent configured for venting an interior of the vial in an intermediate position of the stopper between the first and second positions;
wherein both the first and second sealing surfaces have cylindrical shapes and identical diameters, and wherein the first and second sealing surfaces have a larger diameter than the intermediate region.

2. The vial stopper according to claim 1 , wherein the vent comprises at least one venting slot.

3. The vial stopper according to claim 2 , wherein the venting slot extends in an axial direction of the stopper body.

4. The vial stopper according to claim 1 , wherein the vent comprises at least one venting opening extending through the stopper body.

5. The vial stopper according to claim 1 , wherein an overall cross-sectional area of the vial stopper in the intermediate region through the vent and perpendicular to an axis of the stopper body is 60% to 90% of a cross-sectional area of the mouth of the vial.

6. The vial stopper according to claim 1 , wherein the mouth of the vial defines a cross-sectional area and the vent provides for a range from 2% to 10% of the cross-sectional area of the mouth of the vial to be kept open when the vial stopper is inserted into the mouth of the vial in the intermediate position.

7. A lyophilization vial kit, comprising:
a lyophilization vial comprising a mouth having an interior surface;
a vial stopper having a stopper body, the stopper body comprising:
a first circumferential sealing surface configured for hermetically sealing against the interior surface;
a second circumferential sealing surface for hermetically sealing against the interior surface, the second sealing surface being spaced apart from the first sealing surface in an axial direction of the stopper body;
an intermediate region axially positioned between the first and second sealing surfaces, the intermediate region having a vent configured for venting an interior of the vial in an intermediate position of the stopper;
wherein both the first and second sealing surfaces have cylindrical shapes and identical diameters, and wherein the first and second sealing surfaces have a larger diameter than the intermediate region; and

the mouth of the lyophilization vial being dimensioned to interact with the vial stopper such that, in a first position of the vial stopper in the mouth, the first circumferential sealing surface hermetically seals against the interior surface, and in a second position of the vial stopper in the mouth, the second circumferential sealing surface hermetically seals against the interior surface;
wherein the intermediate position is between the first and second positions and the interior of the vial is vented to outside of the vial via the vent when the vial stopper is in the intermediate position.

8. The lyophilization vial kit according to claim 7 , wherein the first position, the intermediate position and the second position are positions of the vial stopper relative to the vial, wherein the first position, then the intermediate position and then the second position are sequentially reached when the vial stopper is pushed into the mouth of the vial.

9. A closure method for closing a lyophilization vial, the method comprising the following steps:
a) providing a vial stopper having first and second circumferential sealing surfaces and an intermediate region between the first and second sealing surfaces, the intermediate region having a vent;
b) providing a lyophilization vial comprising a mouth having an interior surface;
c) pushing the vial stopper into the mouth until a first position is reached in which the first circumferential sealing surface hermetically seals against the interior surface;
d) pushing the vial stopper further into the mouth of the vial until an intermediate position is reached, whereby the interior of the vial is vented via the vent; and
e) pushing the vial stopper further into the mouth of the vial until a second position is reached in which the second circumferential sealing surface hermetically seals against the interior surface.

10. The closure method according to claim 9 , wherein, after method step c) and before method step d), an optical inspection step of at least one component contained in the vial is performed.

11. A lyophilization method, comprising:
a) providing a vial stopper having first and second circumferential sealing surfaces and an intermediate region between the first and second sealing surfaces, the intermediate region having a vent;
b) providing a lyophilization vial comprising a mouth having an interior surface;
c) adding at least one liquid into the vial;
d) pushing the vial stopper into the mouth of the vial until a first position is reached in which the first circumferential sealing surface hermetically seals against the interior surface;
e) pushing the vial stopper further into the mouth of the vial until an intermediate position is reached;
f) performing at least one lyophilization process with the vial stopper in the intermediate position, thereby converting at least some of the liquid into at least one solid material and venting at least one gaseous substance from an interior of the vial through the vent; and
g) pushing the vial stopper further into the mouth of the vial until a second position is reached in which the second circumferential sealing surface hermetically seals against the interior surface.

12. The lyophilization method according to claim 11 , wherein, with the vial stopper in the first position, an optical inspection step is performed.

13. A lyophilization apparatus, comprising:
A) a plurality of lyophilization vial kits according to claim 7 ;
B) at least one filling device for adding at least one liquid into the vials of the lyophilization vial kits;
C) at least one pushing device for pushing the vial stoppers of the vials into the mouths of the vials in a stepwise fashion, thereby sequentially bringing the vial stoppers into the first position, the intermediate position and the second position;
D) a temperature applicator; and
E) a pressure applicator.

14. A lyophilization apparatus, comprising:
A) a plurality of lyophilization vial kits according to claim 7 ;
B) at least one filling device for adding at least one liquid into the vials of the lyophilization vial kits;
C) at least one pushing device for pushing the vial stoppers of the vials into the mouths of the vials in a stepwise fashion, thereby sequentially bringing the vial stoppers into the first position, the intermediate position and the second position;
D) a temperature applicator;
E) a pressure applicator; and
F) at least one optical inspection device for optically inspecting the lyophilization vial kits.

Assignees

• Hoffmann La Roche

Inventors

• Heinlein Harald

Classifications

• F26B5/06 Primary

  the process involving freezing · CPC title

• B65D51/241 Primary

  provided with freeze-drying means · CPC title

• A61K9/19

  lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)} · CPC title