Vial inspection methods and equipment

Abstract

The present disclosure provides a glass vial illumination and inspection system, which may be provided with a light source and a support. The support may have an inner cavity configured to receive at least a portion of the light source. A recess may be positioned in the support, and the recess is configured to receive at least a portion of the glass vial. The support may be configured to direct light output from the light source at the glass vial to illuminate the vial. The support may be configured to position the vial so that an inspector can manually inspect the illuminated vial for defects. Methods of use are also disclosed.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to U.S. Provisional Application Serial No. 62 / 773,985 filed on November 30, 2018 and U.S. Provisional Application Serial No. 62 / 837,521 filed on April 23, 2019, each of which is hereby incorporated by reference in its entirety.

[0003] Incorporated by Reference

[0004] All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. Technical Field

[0005] The present disclosure relates to inspection systems, and more particularly to systems and methods for inspecting glass vials. Background Art

[0006] Various products, such as drugs, are provided in glass vials. Drugs are usually provided in liquid or lyophilized form. Before or during the glass vial filling process, small cracks or cracks may appear in the glass vials. These defects usually occur at the root of the vial (i.e., its outer, bottom edge), or just below the neck where the cap is attached to the top of the vial. These defects may be difficult to detect and may compromise the integrity of the vial and / or its joints. For example, the drug may leak out of the vial through the crack. Air, moisture or other contaminants may enter the vial through the crack and contaminate the drug. The crack may spread into a larger crack and cause the vial to break open. When this happens at the base of the vial, it is called "lensing".

[0007] What is needed, but not provided, in the prior art are improved systems and methods for inspecting leased vials. Summary of the invention

[0008] The present disclosure relates to vial inspection systems and methods. According to aspects of the present disclosure, a glass vial illumination and inspection system may be provided with a light source and a bracket. The bracket may have an inner cavity configured to receive at least a portion of the light source. A recess may be positioned in the bracket, and the recess is configured to receive at least a portion of a glass vial. The bracket may be configured to direct light output from the light source toward the glass vial to illuminate the vial. The light directed to the vial passes through the vial glass and interacts with defects, making them easier to distinguish. The bracket may be configured to position the vial so that an inspector can manually inspect the illuminated vial for defects.

[0009] In some embodiments, the light source is a flashlight, and the bracket is configured to receive the flashlight in a central hole therein. The bracket can cause the light source to be maintained in a vertical orientation and is configured to maintain the vial above the light source. In some embodiments, the bracket further includes a base having a generally square shape. The top of the bracket is provided with at least two crenels. In some embodiments, the top of the bracket is configured to hold a vial of a first type, and the top is configured to releasably receive a vial adapter, the vial adapter being used to hold a vial of a second type different from the vial of the first type. The adapter may include a plurality of notches around its circumference, wherein the notches are configured to cooperate with the crenels extending from the bracket. In some embodiments, the notches and the crenels cooperate to prevent the adapter from rotating relative to the bracket. The system may further include a plurality of vial adapters, each vial adapter being configured to receive a different type of vial.

[0010] In some embodiments, the system further comprises a vial adapter configured to hold a vial at a non-vertical angle. The vial adapter may be configured to hold a vial at an angle of about 40 degrees from vertical. In some embodiments, the system may further comprise a bottom cover configured to releasably retain the light source within the inner cavity of the support.

[0011] According to other aspects of the present disclosure, a method for inspecting a glass vial is provided. In some embodiments, the method includes providing an illumination and inspection system as described above, inserting a glass vial into a recess of a holder, and inspecting the vial for defects. The method may further include rotating the vial in the recess while inspecting the vial for defects, and in some embodiments of the method, the vial is rotated at least two times. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The novel features of the present invention are particularly set forth in the appended claims. For a better understanding of the features and advantages of the present invention, reference is made to the following detailed description of illustrative embodiments, in which the principles of the present invention are utilized, and to the accompanying drawings:

[0013] FIG. 1 is a side view showing a prior art glass vial to be inspected;

[0014] Figure 2 is an exploded perspective view illustrating components of a first exemplary embodiment of a vial illumination and inspection system constructed in accordance with aspects of the present disclosure;

[0015] Figure 3 It is shown Figure 2 Side view of the top of the vial holder of the system shown, with dimensions in millimeters;

[0016] Figure 4is an exploded perspective view illustrating components of a second exemplary embodiment of a vial illumination and inspection system constructed in accordance with aspects of the present disclosure;

[0017] Figure 5 It is shown Figure 4 An exploded perspective view of the components of the system and the vial adapter 220;

[0018] Figure 6 yes Figure 5 A bottom perspective view of a vial adapter;

[0019] Figure 7 yes Figure 5 A side perspective view of a vial adapter;

[0020] Figure 8 yes Figure 5 A top view of the vial adapter, with dimensions in millimeters;

[0021] Fig. 9 yes Figure 5 Side view of a vial adapter with dimensions in millimeters;

[0022] Fig.10 yes Figure 5 Bottom view of the vial adapter, dimensions in millimeters;

[0023] Fig.11 It is shown Figure 4 An exploded perspective view of the components of the system and the vial adapter 240;

[0024] Fig.12 yes Fig.11 Bottom view of the vial adapter, dimensions in millimeters;

[0025] Fig.13 yes Fig.11 A top perspective view of a vial adapter;

[0026] Fig.14 yes Fig.11 Front view of the vial adapter, dimensions in millimeters;

[0027] Fig.15 yes Fig.11 A top view of the vial adapter with dimensions in millimeters; and

[0028] Fig.16 yes Fig.11 Side view of the vial adapter with dimensions in millimeters. DETAILED DESCRIPTION

[0029] Before further describing the present invention, it should be understood that the present disclosure is not limited to the specific embodiments described, as such may of course vary. It should also be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to limit the present invention, as the scope of the present disclosure will be limited only by the appended claims.

[0030] Where a numerical range is provided, it is understood that each intervening value between the upper and lower limits of the range (based on one-tenth of the unit of the lower limit, unless the context clearly dictates otherwise) and any other stated or intermediate value within the stated range are included within the present invention. The upper and lower limits of these smaller ranges may be independently included in the smaller ranges and are also included within the present invention, subject to any explicitly excluded limits within the stated range. When the stated range includes one or two limits, ranges excluding one or both of those included limits are also included within the present invention.

[0031] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those of ordinary skill in the art to which the present disclosure belongs. Although any methods and materials similar to or equivalent to those described herein can also be used in the practice or testing of the present invention, preferred methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials associated with the cited publications.

[0032] It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a component" includes reference to one or more components, and so on. It should also be noted that the claims may be drafted to exclude any optional elements. As such, this statement is intended to serve as antecedent basis for use of exclusive terminology, such as "only," "only," and the like, in connection with the recitation of claim elements or as a "negative" limitation.

[0033] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior invention.

[0034] Further, the dates of publication provided may be different from the actual publication dates which may need to be independently confirmed.

[0035] Referring to FIG. 1 , an exemplary glass pharmaceutical vial 10 is shown. Pharmaceutical vials are manufactured in a variety of shapes and sizes, but generally have a main portion 12 of constant diameter, a neck 14 of reduced diameter, and a lip 16 or flange located at the top of the neck 14 around the vial mouth (not shown). The diameter of the flange 16 may be greater than the diameter of the neck 14 to provide an undercut portion or collar 18. After the vial 10 is filled with medication, the top may be sealed with a septum material or crown 20, which is held in place by a metal band, crimp, seal, or cladding 22 (which covers a portion of the crown 20, flange 16, and collar 18). The crown 20 may be pierced with a hypodermic needle to withdraw medication from the vial into a syringe. The curved edge located at the bottom of the main portion 12 where the sidewall 24 transitions into the bottom surface or base 26 of the vial may be referred to as the heel 28 of the vial.

[0036] Lensing can occur in glass vials (which can be identified by the base of the vial removed from the bottle body). Vial tension events are caused by defects in the root 28 of the vial 10, which can be difficult to detect due to the refraction of light in the curvature of the vial root. Defects can also occur in the neck of the vial during the crimping process of the seal. Although this neck defect is not considered lensing, it can also be difficult to detect because it is partially obscured by the seal.

[0037] The above defects may compromise the integrity of the vial and / or its contents. For example, in some cases, the drug may leak from the vial through a crack. Air, moisture or other contaminants may enter the vial through the crack and contaminate the drug. The crack may spread into a larger crack and cause the vial to break open. Therefore, it is necessary to detect defects in the vial before any of the above adverse consequences occur. Detecting defects as soon as possible can enable the vial to be removed from distribution as early as possible, thereby improving public safety and reducing costs. According to aspects of the present disclosure, the vial can be inspected for cracks or fissures immediately before and / or after filling and sealing.

[0038] refer to Figure 2, a first exemplary embodiment of a vial lighting and inspection system 100 constructed in accordance with aspects of the present disclosure will be described. In this exemplary embodiment, the inspection system 100 is configured to hold one vial 10 at a time for inspection, each vial 10 being a 100cc clear glass vial, but the system 100 can be modified to inspect vials of other sizes and types, as described below, the system 100 includes a vial holder bottom 102 and a vial holder top 104. The vial holder bottom 102 can be provided with a base 106 having a generally square shape as shown to increase stability and allow the system to be more easily indexed in a desired orientation. The vial holder bottom 102 has an inner cavity (not shown) configured to receive a light source 108. The light source 108 emits light in an upward direction toward the vial 10. In this exemplary embodiment, the light source 108 is a standard LED flashlight having a maximum diameter of 1 inch, but other types of light sources may also be used, such as a remotely located light source coupled to the vial holder bottom 102 by a fiber optic bundle. The upper cylindrical portion of the holder bottom 102 may be provided with an outer groove 110 sized to partially receive an O-ring 112. In some embodiments, the vial holder bottom 102 and the vial holder top 104 may be made of a thermoplastic such as polylactic acid (PLA). These components may be produced using 3-D printing, injection molding, or other manufacturing techniques.

[0039] refer to Figures 2 to 3 , the vial holder top 104 can be provided with an inner hole 114 sized to receive the upper cylindrical portion of the holder bottom 102. The inner hole 114 can be provided with an inner groove 116 sized to partially receive the O-ring 112. With this arrangement, the vial holder top 104 can be slid onto the vial holder bottom 102 and releasably locked in place by the O-ring 112.

[0040] The vial holder top 104 may be configured to hold a 100cc clear glass vial in an inverted position so that the base may be inspected for defects. Figure 3As shown, the support top 104 can be provided with an inner cavity 118 for receiving the vial 10. The cavity 118 can have a stepped downward portion 120, which is sized to abut against the shoulder of the vial 10, thereby maintaining the vial at a predetermined height. In this exemplary embodiment, when the vial 10 is fully inserted therein, the bottom surface of the vial is recessed below the top edge 122 of the support top 104, so that the support top 104 provides a uniform background for viewing the bottom surface or "base" of the vial. This white uniform background enhances the inspector's ability to identify dark / opaque defects that may exist at the base of the lower sidewall area of ​​the vial. In other embodiments, the bottom surface of the vial 10 may be flush with the top edge 122 or protrude. The support top 104 can be made of a white material or coated with a white material to assist in inspecting the vial 10. The support top 104 can be provided with a cutout portion 124 extending 180 degrees in a circumferential direction, as shown in the figure, for exposing a portion of the side of the vial 10. With this arrangement, the inspector can rotate the vial 10 while it is inserted into the rack top 104, such as by using his or her thumb on the side of the vial.

[0041] like Figure 2 As shown, the system 100 can be provided with a diffuser plate 126 in the bottom 102 of the support between the light source 108 and the vial 10 to optimize the lighting conditions to locate the defects in the vial 10. In some embodiments, the thickness of the diffuser plate 126 is 0.3 mm. In some embodiments, a plurality of diffusers with various thicknesses are provided, and the diffusers are configured to be interchangeable depending on the type of defect being inspected. A bottom cover or spacer ring 128 can be positioned within the bottom of the vial support bottom 102 to retain the light source 108 therein. The bottom cover 128 can be provided with an outer diameter larger than the inner diameter of the support bottom 102, and its circumference can be provided with a longitudinal gap. With this arrangement, when the bottom cover 128 is inserted or removed from the support bottom 102, the bottom cover can be bent inward (narrowing the longitudinal gap). When in the support bottom 102, the bottom cover 128 applies an outward force to retain itself and the light source 108 in the support bottom 102. This allows the on / off switch of the light source 108 to be easily removed and accessed.

[0042] In operation, the inspector removes the bottom cover 128 and / or the light source 108 to turn on the light source and replaces both into the vial holder bottom 102. In some embodiments (not shown), the light source 108 may be inserted from the top of the vial holder bottom 102 with or without first removing the vial holder top 104. The inspector then places the vial 10 in an inverted orientation in the top recess of the vial holder top 104. The lighting, viewing, and background conditions provided by the inspection system 100 allow for easier detection of defects in the root of the vial 10. The inspector may rotate the vial 10, the vial holder top 104, and / or the vial holder bottom 102 at least 360 degrees to view it from every angle. In some embodiments, the vial 10 may then be removed and replaced into the holder top 104 in an upright orientation to inspect other portions of the vial 10, such as the neck area below the seal. The vial 10 may then be removed from the system 100 and replaced with the next vial to be inspected. If the inspector wishes to inspect different vial types and / or inspect for different defect types, the vial holder top 104 can be removed from the vial holder bottom 102 and replaced with a different vial holder top customized for the different vial types and / or defects. The diffuser 126 can also be replaced with a different diffuser at this time.

[0043] refer to Figure 4 , a second exemplary embodiment of a vial lighting and inspection system 200 constructed in accordance with aspects of the present disclosure will be described. The inspection system 200 is constructed and operates in a similar manner to the system 100. In this exemplary embodiment, the inspection system 200 includes a vial defect lighting rack 202 configured to receive a light source 108 from below within a central cavity. A light source base 204 may be provided within the lighting rack 202 to retain the light source 108 and raise it as close to the vial 10 as possible. Light from the source 108 propagates upward through the central cavity of the rack 202 to illuminate the vial 10, which is received directly in the top of the rack 202 in an inverted orientation. In some embodiments, the rack 202 is configured to receive a 20cc glass vial.

[0044] The top of the lighting support 202 may be provided with two, three or more crenellations 206. In this exemplary embodiment, the crenellations 206 have multiple functions. First, they are configured to securely hold the vials 10 while allowing a more complete view of the illuminated vials. The reduced diameter shoulders 208 at the base of the crenellations 206 allow the inverted neck of the vials 10 to extend into the support 202, but prevent the body of the vials from falling below the crenellations 206. Therefore, the bottom root and the entire body of the vials 10 can be observed when they rotate within the crenellations 206. In addition, the crenellations 206 are used to releasably interlock with the mating notches on the vial adapter, as described below, to prevent the adapter from rotating relative to the support 202 and to prevent light from escaping between the adapter and the support 202.

[0045] refer to Figure 5 , shows a vial inspection system 200 having a vial adapter 220. The adapter 220 is assembled to the top of the lighting bracket 202 (wherein the 20cc vial is mounted as described above), and illuminates the 15cc vial and inspects it for defects. In the exemplary embodiment, the adapter 220 has three notches 222 arranged around its lower periphery and configured to receive three crenellations 206 extending from the top of the bracket 202. The adapter 220 has a center hole that is configured to receive a 15cc vial in an upright orientation. In some embodiments, the adapter 220 has a cutout portion 224 as shown, which allows a portion of the body and / or bottom root of the vial 10 to be inspected. As described above, the entire body and / or root can be inspected by rotating the vial 10 within the adapter 220. The adapter 220 has an upper portion that can be tilted relative to the lower portion of the adapter. In some embodiments, the tilt angle is 40 degrees from the vertical, such as Fig. 9 As shown. Applicants have found that this angle provides exceptional illumination of defects in vial 10. In other embodiments, the tilt angle is about 20 degrees to about 60 degrees from vertical. Adapter 220 can be made of or coated with a dark or opaque material to reduce light leakage through the adapter.

[0046] refer to Figures 6 to 10 , provides views of various sizes of the vial adapter 220 described above.

[0047] refer to Fig.11 , a vial inspection system 200 having a vial adapter 240 is shown.

[0048] The adapter 240 fits to the top of the lighting bracket 202 (where the 20cc vial is mounted as described above) and illuminates the 6cc vial and inspects it for defects. In this exemplary embodiment, the adapter 240 has three notches 242 arranged around its lower periphery and configured to receive three crenellations 206 extending from the top of the bracket 202. The adapter 240 has a central hole that is configured to receive a 6cc vial in an inverted orientation. In some embodiments, the adapter 240 has a cutout portion 244 as shown, which allows light from the light source 108 to ideally illuminate the portion of the vial 10 that is easy to detect, while limiting the amount of light directed to the inspector. A label or lettering 246 such as "Face this side" can be provided on the adapter 240 opposite the cutout portion 244 to indicate which side of the adapter 240 should be open to the inspector.

[0049] refer to Figures 12 to 16 , provides views of various sizes of the vial adapter 240 as described above.

[0050] The inspection system disclosed herein can be used to spot check a batch of vials, or can be used to inspect 100% of a batch of vials. According to aspects of the present disclosure, in some embodiments, the inspector must first be qualified / certified for the use of the fixture. Once the inspector is qualified to use the fixture appropriately, a good manufacturing practice (GMP) inspection and release of the batch of vials can be performed. In certain identification schemes, a set of acceptable vials with defective batches and numbers and randomly assembled can be provided. In some cases, there is a mix of at least four acceptable vials with one defective vial. The set can also include a master defect list that describes the defect category, type, and defect location for each vial included in the set. When the detection rate of defects reaches 100%, according to certain schemes, the manual inspector is considered qualified.

[0051] In some embodiments, the following definitions may be used to classify defects:

[0052] Serious defects: defects that affect consumer safety when using the product and / or do not comply with mandatory regulations.

[0053] Major defects: defects that may negatively affect the functionality of the product.

[0054] Minor Defect: Any defect known not to have a negative impact on the form, fit or function of the product or on the health of the patient.

[0055] According to aspects of the present disclosure, an exemplary inspection method is provided below:

[0056] Vial fixture setup and use

[0057] 1. Ensure that all necessary materials are available (e.g. Figure 2 Materials shown in

[0058] 2. Arrange the enhanced inspection device by inserting the provided flashlight from underneath the device with the light facing upward. The flashlight should be set to the "bright" setting. This can be achieved by pressing the power button once while the power is turned on.

[0059] NOTE: Flashlight batteries should be replaced at the beginning of each day before any inspections are performed.

[0060] 3. Insert the 3D printed prop under the flashlight to push the flashlight to the specified height.

[0061] 4. Place the device in front of a black background. Make sure the side with the label "Face this side" is facing you.

[0062] 5. Adjust the table and chair so that the top of the clamp is approximately at eye level.

[0063] Enhanced Focus Inspection Technology

[0064] 1. Before inspecting the tensioned vial defect set, inspect the provided labeled and unlabeled sample defect vials using the techniques described in Steps 2 and 3. Ensure that the chair and bench are adjusted to various heights for ergonomics and proper inspection using the fixture.

[0065] 2. Carefully invert the vial and place it over the opening of the device.

[0066] 3. Slowly and gently rotate the vial completely at least two (2) times and inspect the root area for defects against a black background only. Do not rotate the clamp. Hold the clamp still (steady it with one hand if necessary) and rotate the vial in the clamp with your index finger.

[0067] The length of time for each vial inspection must be at least 10 seconds, but may be longer if necessary. There is no time limit for the inspection of each vial.

[0068] 4. If the root area of ​​the vial has no defects, place the vial in the "Acceptable" tray.

[0069] 5. If a vial has severe defects in the root area*, cull and separate from the colony, placing the vial in a "reject" tray. Do not remove any caps from the rejected vials. Simply separate from the main colony.

[0070] 6. Perform a pull-off for 5 minutes every 15 minutes.

[0071] 7. Repeat steps 2-6 until all vials in the kit have been inspected.

[0072] 8. After all vials have been checked, record the results on the Protocol Data Sheet.

[0073] *If any other root defects are observed, they should be removed (see defect types listed above.)

Claims

1. A glass vial lighting and inspection system comprising: light source; a bracket having an inner cavity configured to receive at least a portion of the light source; a recess positioned in the holder and configured to receive at least a portion of a glass vial, wherein the support is configured to direct light output from the light source toward the glass vial to illuminate the vial, and wherein the support is configured to position the vial so that an inspector can manually inspect the illuminated vial for defects, wherein the top of the holder is configured to hold a first type of vial, and the top is configured to releasably receive a vial adapter for holding a second type of vial different from the first type of vial, wherein the vial adapter includes a plurality of notches around its circumference, The notch of the vial adapter is configured to cooperate with at least two castellations extending from the support to prevent the vial adapter from rotating relative to the support but to allow the illuminated vial to rotate relative to the vial adapter and the support.

2. The glass vial illumination and inspection system of claim 1, wherein the light source is a flashlight and the bracket is configured to receive the flashlight in the central aperture therein.

3. The glass vial illumination and inspection system of claim 2, wherein the support is configured to hold the light source in a vertical orientation and is configured to hold the vial above the light source.

4. The glass vial illumination and inspection system of claim 1, wherein the support further comprises a base having a generally square shape.

5. The glass vial lighting and inspection system according to claim 1, wherein the top of the support is provided with at least two of the crenelations.

6. The glass vial illumination and inspection system of claim 1, wherein the glass vial illumination and inspection system further comprises a plurality of vial adapters, each of the vial adapters being configured to receive a different type of vial.

7. The glass vial illumination and inspection system of claim 1, wherein the glass vial illumination and inspection system further comprises a vial adapter configured to hold a vial at a non-vertical angle.

8. The glass vial illumination and inspection system of claim 7, wherein the vial adapter is configured to hold a vial at an angle of about 40 degrees from vertical.

9. The glass vial illumination and inspection system of claim 1, further comprising a bottom cover configured to releasably retain the light source within the interior cavity of the holder.

10. The glass vial lighting and inspection system of claim 1, further comprising: Multiple vial adapters, wherein the support is configured to hold the light source in a vertical orientation and to hold the vial above the light source, wherein the top portion of the holder is configured to releasably receive the plurality of vial adapters one at a time, and Wherein at least one of the plurality of vial adapters is configured to hold a vial at a non-vertical angle.

11. The glass vial illumination and inspection system of claim 10, wherein the support further comprises a base having a generally square shape.

12. The glass vial illumination and inspection system of claim 10, wherein at least one of the plurality of vial adapters is configured to hold a vial at an angle of about 40 degrees from vertical.

13. The glass vial illumination and inspection system of claim 10, further comprising a bottom cover configured to releasably retain the light source within the interior cavity of the support.

14. A method for inspecting a glass vial, the method comprising: Providing a glass vial lighting and inspection system according to claim 1; inserting a glass vial into the recess of the holder; as well as The vials were inspected for defects.

15. The method of claim 14, further comprising rotating the vial within the recess of the holder while inspecting the vial for defects.

16. The method of claim 15, wherein the vial is rotated at least two times.

17. A method for inspecting a glass vial, the method comprising: Providing a glass vial lighting and inspection system according to claim 10; inserting a glass vial directly into the recess of the holder, or inserting a glass vial directly into a vial adapter located in the recess of the holder; as well as While inspecting the vial for defects, manually rotate the vial at least two revolutions within the holder's recess or the vial adapter.

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