SEALABLE AND AUTOSAMPLER COMPATIBLE MICROAMPULE FOR PACKAGING AND A METHOD FOR PERSEVERING ANALYTICAL AND BIOPHARMACEUTICAL SAMPLES

Abstract

The present invention is a sealable microampule for storage of environment sensitive material which is autosampler compatible and provides a space, small enough to make low volumes of liquid available for auto-injector needle. The microampule fits inside an autosampler vial and breaks open at a certain height to allow stable accommodation inside the autosampler vial. The microampule has a longer length which provides space to apply the force to snap break the seal at the opening level of the autosampler vial.

Claims

1. A microampule and vial device, comprising: a microampule that is divided into a top portion with a top-height and a bottom portion with a bottom-height, which are divided by a scoring line to allow for the breakage of the microampule, wherein the bottom portion is configured to hold a fluid, and a vial configured to receive and hold the bottom portion of the microampule, the vial having a vial-height that matches a bottom-height of the microampule and wherein the top portion of the microampule sticks out of the vial, whereby the top portion of the ampule is used as a handle to apply a force to break off the top portion from the scoring line, thereby allowing access to the fluid in the bottom portion.

2. The microampule and vial device of claim 1, wherein the vial is configured to receive a sealable cap once the top portion of the microampule is broken off.

3. The microampule and vial device of claim 1, wherein the vial is fused to the microampule just below the scoring line.

4. The microampule and vial device of claim 1, wherein the bottom of the bottom portion has a V-shaped, round shaped, flat shaped or narrow shaped for high recovery.

5. The microampule and vial device of claim 1, further having a spring placed inside the vial, wherein the bottom of the bottom portion engages with the spring to push the microampule upwards.

6. The microampule and vial device of claim 1, wherein the microampule is cylindrical.

7. The microampule and vial device of claim 1, wherein the microampule is made from glass, plastic or ceramic, and can contain borosilicate, lime soda and lead, and can be clear or colored.

8. The microampule and vial device of claim 1, wherein the height of the microampule is between 40 mm to 100 mm.

9. The microampule and vial device of claim 1, wherein the outer diameter of the microampule is between 5 mm to 8 mm and an internal diameter of the microampule is between 3 mm to 6 mm.

10. The microampule and vial device of claim 1, wherein the dimension of the microampule is configured to store air sensitive material comprising material for analytical standards and biopharmaceuticals in volumes less than 300 μl.

11. A method for manufacturing a sealable and vial compatible microampule, comprising: making a microampule by closing a bottom of a glass tube; placing a specified volume of a fluid inside the microampule; heating and closing a top of the microampule; scoring the microampule at a scoring height to divide the microampule into a top portion and a bottom portion, placing the microampule inside a vial.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Embodiments herein will hereinafter be described in conjunction with the appended drawings provided to illustrate and not to limit the scope of the claims, wherein like designations denote like elements, and in which:

[0030] FIG. 1A (Prior art) shows a conventional ampoule that can be sealed and can protect the containment;

[0031] FIG. 1B (Prior art) shows a screw cap vial with or without inserts;

[0032] FIG. 1C (Prior art) shows a glass low volume insert inside a screw cap vial;

[0033] FIG. 2 shows the process of manufacturing, packaging and using the microampule of the present invention;

[0034] FIG. 3A is a view of a V-shape microampule according to the present invention;

[0035] FIG. 3B is a view of a round bottom microampule according to the present invention;

[0036] FIG. 3C is a view of a flat bottom microampule according to the present invention;

[0037] FIG. 3D is a view of a high-recovery microampule according to the present invention;

[0038] FIG. 3E is a view of a spring-attached microampule according to the present invention;

[0039] FIG. 4A is a view of a microampule showing the scoring height;

[0040] FIG. 4B is a view of a microampule with spring showing the scoring height;

[0041] FIG. 5A shows a microampule made independent of the autosampler vial;

[0042] FIG. 5B shows the microampule made independent of the autosampler vial and then fused to the autosampler vial;

[0043] FIG. 5C shows the microampule made as a part of the autosampler vial;

[0044] FIG. 5D shows the microampule in two pieces where a glass micro-lid is placed on the top of the microampule before sealing;

[0045] FIG. 5E shows the microampule in two pieces where a glass micro-lid is inserted on the opening of the microampule at the top before sealing;

[0046] FIG. 5F shows the microampule in two pieces where a screw/bolt shaped glass micro-lid screwed on the top of the microampule before sealing;

[0047] FIG. 6A shows the advantage of adding a top spacer in preventing heat induced degradation of the sample during sealing process;

[0048] FIG. 6B shows an embodiment to produce the sealed microampoule according to the present invention;

[0049] FIG. 6C shows another embodiment to produce the sealed microampoule according to the present invention;

[0050] FIG. 6D shows another embodiment to produce the sealed microampoule according to the present invention, and

[0051] FIG. 6E shows another embodiment to produce the sealed microampoule according to the present invention;

[0052] FIG. 7A shows the microampule without a spacer which is broke short and did not fit properly in the autosampler vial to show the advantage of adding a top spacer to allow the sealed microampule snap break at the right position to fit in an autosampler vial according to the present invention;

[0053] FIG. 7B shows the microampule with a short spacer which upon breaking may cause chopped edges or destroy the microampule to show the advantage of adding a top spacer to allow the sealed microampule snap break at the right position to fit in an autosampler vial according to the present invention, and

[0054] FIG. 7C shows the advantage of adding a right length for the top spacer to allow the sealed microampule snap break at the right position to fit in an autosampler vial according to the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0055] According to FIG. 2 the microampule 100 is a cylindrical container in dimensions and scoring level tubes for analytical autosampler by snap breaking. The microampule can be made of any material including but not limited to any type of glass (borosilicate, lime soda, lead, clear, amber, etc.), plastic, ceramic, etc. The microampule is made by closing the bottom end of a glass tube in various shapes.

[0056] The microampule can be sealed on the top and placed inside an autosampler vial and break open at a certain height to be used right after snap breaking, Therefore, removing the liquid transfer step while keeping the material intact from manufacturing step to the point of use.

[0057] The microampule has a body comprising an outer diameter (OD) of 5-8 mm ±1.5 mm and an internal diameter (ID) of 3-6 mm±1 mm configured to provide a space, small enough to make low volumes of liquid available for auto-injector needle. The height of the microampule is between 40 mm±4mm-100 mm±4 mm. The microampule has a bottom portion 101 as a scoring height and a top portion 102 as a spacer. The bottom portion 101 and the top portion are spaced apart at a scoring point 104. The top portion of the microampule acts as a handle so that the longer length of the spacer 102 provides a space to apply the force to snap break the seal at the opening level of the autosampler vial.

[0058] The bottom portion 101 has a scoring height of 32-25 mm and serves as the sample container 300 and the top portion 102 serves as a spacer. The “microampule” is scored by a diamond scoring tool at the height of 25 mm-33 mm so that after breaking the ampoule 100, the opening of the insert aligns with the opening of the autosampler vial 400 for screw capping. The top portion 102 of the microampule works as a spacer to prevent the heat to spread down to the liquid 300 when heat sealing the ampule. The top portion 102 of the microampule further acts as a handle. The longer length of the microampule 100 provides a space to apply the force to break the microampule 100 at a certain position on the walls so that its opening aligns with the opening of the autosampler vial 400 for tight screw capping or crimp capping. The microampule is suitable to store air sensitive material such as analytical standards and biopharmaceuticals in volumes under 300 μl.

[0059] As shown in FIGS. 3A to 3E the microampule 100 is made by closing the bottom end of a glass tube in various shapes. As shown in FIG. 3A the bottom end can be in v-shape, or round bottom as shown in FIG. 3B, flat bottom as shown in FIG. 3c, high-recovery as shown in FIG. 3D, or spring-attached as shown in FIG. 3E, etc.

[0060] The microampule of present invention 100 uses a closed end glass or plastic container that is slim enough to hold small quantities of liquid in proper height for auto injector needle, while the tube can be used in an autosampler compatible vial acting as a holder. This makes the system: 1) sealable after packaging 2) able to hold small volumes of liquid 3) compatible with autosampler systems.

[0061] According to FIGS. 4A and 4B the microampule has a scoring height 103. The scoring height 103 depends on the shape of the microampule 100. According to FIG. 4B if the microampule 100 is spring-attached to push the insert up, then the scoring point 104 would be closer to the bottom portion 101. The tube should be scored by a scoring tool to allow removal of the spacer 102. The scoring could be made at the manufacturing step or by the end user.

[0062] According to FIGS. 2 and 5A in manufacturing 60 the Microampule can be made as a stand-alone microampule 100a and independent of the autosampler vial 400, or fused to the autosampler vial 100b as shown in FIGS. 5B and 5C. The fusion can happen by fusing an individual microampule with an individual autosampler. In this case the microampule is made independent of the autosampler vial and is then fused to the autosampler vial or by making an autosampler vial that contains the microampules in its primary body at the moulding step (as shown in FIG. 5C). In this case the microampule 100c is a part of the autosampler vial design and makes a seamless assembly.

[0063] According to FIGS. 5D to 5F the Microampule can come in a single piece 100D that can be sealed by heat-fusing at the top, or in multiple pieces where an auxiliary glass piece will act as a micro-lid 410 to close the top of the ampule before sealing.

[0064] According to FIG. 6A the dimensions of the microampule is important and specific to make the microampule fit inside a 8-425/9-425/10-425 autosampler vial. The height of the microampule is also important and specific because it adds a spacer 102 to the insert. The advantage of adding the spacer is as following: [0065] a) Increase the height of the tube which acts as a buffer to prevent the heat flow 200 to run down to microampule when the glass is being sealed by flame and therefore, to protect the containment 300 in the bottom portion 101 of the microampule from the heat damage; [0066] b) The spacer 102 works as a handle/lever to increase the force for snap breaking the microampule with fingers at the breaking point/scoring point 104.

[0067] There are several ways to produce the microampoule with the previously specified properties and dimensions. As shown in FIG. 6B one can heat 200 the microampoule at the top until the wall of the tube melts down and collapses to passively make a seal (top seal). As shown in FIG. 6C, one can heat the tube in the middle and seal the tube by pressing the two edges of the softened microampule to fuse the building material together. As shown in FIG. 6D one can start with a longer glass tube, heat it at the sealing point 204 and then remove the top part of the long glass tube to result in the microampule. As shown in FIG. 6E, a glass lid 110 can be placed on the top of the ampule before sealing and fuse the glass of the lid to the body of micro ampule to seal the top.

[0068] FIG. 7A shows the microampule without an spacer which is broke short and did not fit properly in the autosampler vial to show the advantage of adding a top spacer to allow the sealed microampule snap break at the right position to fit in an autosampler vial. If the spacer is not present, the user can not break the glass at the scoring point without damaging the tube. FIG. 7B shows the microampule with a short spacer which by breaking may cause chopped edges or destroy the microampule.

[0069] FIG. 5C shows the advantage of adding a right length for the top spacer to allow the sealed microampule snap break at the right position to fit in an autosampler vial. It is important to mention that the specified height of the tube and the specified position of the scoring point makes it possible to open the microampule by breaking the insert tube inside an autosampler vial with a height of 32 mm and mouth opening of 5-7 mm and pushing with fingers. This design makes it very simple to quickly open a sealed tube and provides it to the autosampler for analysis.

[0070] Referring to FIG. 2 the following is the process of manufacturing, packaging and using the microampule:

[0071] Packaging 70: The packaging is the process of placing the containment inside the microampule and sealing it for the purpose of storage. It takes place in two main steps: [0072] a) Adding (inserting) the containment (liquid or solid) to the microampule: The insertion process can be done at the manufacturing facility where the samples are prepared for the end user working out of the facility, or in a lab where the packaging person is the same as the end user. Placing the sample inside the microampule can be accomplished by a human using a pipette or by machine. The added volume is typically under 200 μl. [0073] b) Sealing the microampule at the top using heat. If glass is used as the packaging material, the microampule can be sealed by flame, plasma arc, metal element, or any other device that can melt the glass to bind it together for sealing. If plastic is used any low heat generating device such as hot press, flame, heat gun, etc. could be used to seal the microampule. The sealing process removes the change of air exchange between the sample and the environment to zero.

[0074] Point of use 80: To use the microampule, the user has to break the glass or plastic to expose the containment to the autosampler. The microampule is designed to work with autosampler systems that use autosampler vials. Although glass inserts are being used widely in the industry, autosampler trays that hold insert by itself are not readily available. The common practice is to open a screw cap autosampler vial, place the insert inside the vial and then cap the vial. In this fashion, the vial works as a holder for the insert. The auto-injector needle can access the containment by piercing through the cap septum at the center and aspirating the liquid.

[0075] The design of the microampule makes it possible for the user to snap break the glass with ease by: placing the insert inside the vial, aligning the scoring point with the opening of the vial and gently pushing the spacer against the wall of the vial. The spacer will be discarded and the insert which perfectly fits inside the vial after capping and can hold small quantities of the liquid. The specification of the design renders the microampule a new ready-to-use packaging system where the sample is ready by a simple snap break. It is important that the glass is scored at the right position on the insert, otherwise the insert will be too long to screw cap the vial or it would be too short for the needle to safely access it.

[0076] The foregoing is considered as illustrative only of the principles of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, it is not desired to limit the invention to the exact construction and operation shown and described, and accordingly, all suitable modifications and equivalents may be resorted to, falling within the scope of the invention.

[0077] With respect to the above description, it is to be realized that the optimum relationships for the parts of the invention in regard to size, shape, form, materials, function and manner of operation, assembly and use are deemed readily apparent and obvious to those skilled in the art, and all equivalent relationships to those illustrated in the drawings and described in the specification are intended to be encompassed by the present invention.