Patent Description:
Vials containing agents, medicine, products or biological and/or chemical agents are fragile and require careful handling. Further, because common shapes of vials are cylindrical, it can be difficult to label the vials, for example, when vials are labeled in bulk. Specialized equipment or manual labor has been employed to label vials. However, current labelling of vials remains cumbersome and expensive. Further, the storage of bulk vials can require bulky equipment to make sure that the vials do not tip over and spill.

What is needed are devices, methods and systems for efficient packaging and labelling of a vial and/or a sterile product. <CIT> describes a medical implant package including a vial and a cap connected by a hinge. The vial includes a cavity for housing at least a portion of a dental implant. To access the implant the cap is rotated about the hinge from a closed position to an open position.

The present invention provides a packaging system for housing a sterile product as recited in claim <NUM>. Optional features are recited in the dependent claims.

The primary packaging holder receiving portion can have a region with at least a portion of an interior surface having an arc-shape that is configured to receive and hold a primary packaging holder having a substantially cylindrical shape.

The secondary packaging holder can have a base at a second end opposite to the first end, and can have at least one substantially planar wall that extends from the first end to the second end of the secondary packaging holder.

The base of the tertiary packaging holder can be rectangular and the at least one substantially planar wall can extend from at least one side of the base.

The at least one substantially planar wall can extend from the first end to the second end of the tertiary packaging holder. An interior surface of the at least one planar wall of the tertiary packaging can contact an exterior surface of the at least one surface of the secondary packaging holder.

Two substantially planar walls of the tertiary packaging holder can extend from respective sides of the base to the secondary packaging holder receiving portion. Further, two substantially planar walls of the secondary packaging holder can extend from the respective sides such that interior surfaces of the two substantially planar walls of the tertiary packaging holder contact exterior surfaces of the two substantially planar walls of the secondary packaging holder.

Two non-planar walls of the tertiary packaging holder can extend from other respective sides of the base to the secondary packaging holder receiving portion.

Each of the non-planar walls of the tertiary packaging holder can outline an aperture in a middle section of the non-planar wall. Further, spacings in between the two planar walls of the secondary packaging holder can overlap with the apertures when the secondary packaging holder is securely and irreversible held. The overlapped apertures and spacings can allow for direct access through the walls on the side.

The apertures can allow for direct access of least a portion of a side of the primary packaging holder when the primary packaging holder is securely and irreversibly held in the secondary packaging holder and tertiary packaging holder.

The spacings of the secondary packaging holder can extend from the primary packaging holder receiving portion to a lip on the base.

The base of the secondary packaging holder along each space can include a lip that borders the base in between the substantially planar walls and that extends towards the first end.

The lips of the secondary packaging holder can be configured to contact an interior surface of substantially arc-shaped walls of the tertiary packaging holder.

The primary packaging holder can include a sealable port configured to enclose an interior space of the primary packaging holder when sealed. The secondary and tertiary packaging holders can permit direct access to the interior space via the port.

The tertiary packaging holder can have an external profile configured to permit close packing of a plurality of tertiary packaging holders in at least two dimensions.

The primary packaging holder can be a vial.

The present invention also provides a method of packaging a sterile product as recited in claim <NUM>. Optional features are recited in the dependent claims.

The depositing of a sterile product in the interior space can occur after securing the primary packaging holder to the secondary packaging holder. The depositing a sterile product in the interior space can occur after securing the secondary packaging holder to the tertiary packaging holder.

The method can further include affixing an identifying label to the substantially planar exterior surface of the tertiary packaging holder.

The secondary packaging holder can be configured to snap fit to a neck of the primary packaging holder to securely and irreversibly hold the primary packaging holder.

Additional features, advantages, and embodiments of the invention are set forth or apparent from consideration of the following detailed description, drawings and claims. Moreover, it is to be understood that both the foregoing summary of the invention and the following detailed description are exemplary and intended to provide further explanation without limiting the scope of the invention as claimed.

The term "securely" is intended to have a broad meaning that may be used in holding packaging units. A primary packaging holder can be "securely" held by a secondary packaging holder when the secondary packaging holder is sized to hold the primary packaging holder without allowing movement of the primary unit relative to the secondary packaging holder. Similarly, a secondary packaging holder can be "securely" held by a tertiary packaging holder when the tertiary packaging holder is sized to hold the secondary packaging holder without allowing movement of the secondary packaging holder relative to the tertiary packaging holder.

The term "irreversibly" is intended to have a broad meaning as, for example, configured to remain as assembled during normal use; tamper evident.

The term "primary packaging holder" is intended to have a broad meaning as, for example, a packaging unit or device configured to hold a sterile product and maintain sterility of the sterile product during handling, storage, and transportation.

The term "secondary packaging holder" is intended to have a broad meaning as, for example, a packaging unit or device configured to hold a primary packaging holder, in particular to securely and irreversibly hold the primary packaging holder.

The term "tertiary packaging holder" is intended to have a broad meaning as, for example, a packaging unit or device configured to hold a secondary packaging holder, in particular to securely and irreversibly hold the secondary packaging holder.

The term "non-enclosing" is intended to have a broad meaning as, for example, a secondary and/or tertiary packaging holder is non-enclosing if at least a portion of the exterior of the primary packaging holder is accessible without disrupting the secondary and/or tertiary packaging holder.

The term "direct access" is intended to have a broad meaning as, for example, access to an interior space of a primary packaging holder without the need to open, disrupt or tamper with a secondary or tertiary packaging holder.

<FIG> shows a perspective view of a packaging apparatus <NUM> for holding a sterile product. The packaging apparatus <NUM> can include a secondary packaging holder <NUM> having a base <NUM> at a first end <NUM> and a receiving portion <NUM> at an opposing second end <NUM>. The secondary packaging holder <NUM> can be configured to receive and securely and irreversibly hold a primary packaging holder <NUM>. The packaging apparatus <NUM> can be configured to provide an area adapted for labeling and/or providing identification information, preferably, directed to primary packaging holder <NUM>. As shown, packaging apparatus <NUM> can include at least one substantially planar wall <NUM> that can extend from the first end <NUM> to the second end <NUM>. The at least one substantially planar wall <NUM> can be configured to affix an identifying label thereto.

An interior of the secondary packaging holder <NUM> can be configured to receive the primary packaging holder <NUM> and to snap fit to a neck <NUM> of the primary packaging holder <NUM> to securely and irreversibly hold the primary packaging holder <NUM>. The primary packaging holder <NUM> can be permanently secured in the secondary packaging holder <NUM>. When the primary packaging holder <NUM> is securely and irreversibly held, the primary packaging holder <NUM> can have a portion <NUM> exposed outside of the secondary packaging holder <NUM>. As shown, the exposed portion <NUM> can be based on a height relationship between the secondary packaging holder <NUM> and the primary packaging holder <NUM>. This can allow for the secondary packaging holder <NUM> not to interfere with the integrity of a cap <NUM> of the primary packaging holder <NUM>. The height relationship between the secondary packaging holder <NUM> and the primary packaging holder <NUM> can also allow for the secondary packaging holder <NUM> not to interfere with removal of the cap <NUM>. For example, when the primary packaging holder <NUM> is being securely and irreversibly held, an entirety of the cap <NUM> can be exposed outside the secondary packaging holder <NUM> allowing for cap <NUM> removal. Further, product from the primary packaging holder <NUM> can also be removed without regard to interference from the secondary packaging holder <NUM>.

The secondary packaging holder <NUM> can be made of plastic or other sturdy and resilient materials. The secondary packaging holder <NUM> can be transparent or opaque. At least one non-planar wall <NUM> can extend from a side of the base <NUM> different from the at least one substantially planar wall <NUM> of the secondary packaging holder <NUM>. The at least one non-planar wall <NUM> can extend from the first end <NUM> to the second end <NUM>. The secondary packaging holder <NUM> can allow for the primary packaging holder <NUM> to be thawed within the secondary packaging holder <NUM> in a variety of thaw mechanisms. For example, thawing can take place in a customized dry heater block to fit to the shape of the secondary packaging holder <NUM>. Further, for example, thawing can take place in a saline bath or at room temperature.

Each of the non-planar walls <NUM> can outline an aperture <NUM> along a substantial portion of a longitudinal axis of the non-planar wall <NUM>. The aperture <NUM> can provide for direct access to the primary packaging holder <NUM>. The primary packaging holder <NUM> can include a sealable port <NUM> configured to enclose an interior space of the primary packaging holder <NUM> when sealed. The sealable port can be sealed by the cap <NUM>. The secondary and tertiary packaging holders (see <FIG>) permit direct access to the interior space via the sealable port <NUM>.

<FIG> shows an identifying label <NUM> affixed to the secondary packaging holder for illustration purposes. However, the identifying label <NUM> is not part of the secondary packaging holder <NUM>. The identifying label <NUM> can be a primary label that can be used to identify the product of the primary packaging holder <NUM>. The identifying label can be permanently affixed to the secondary packaging holder <NUM>. As shown, the secondary packaging holder <NUM> can be a vial holder. The secondary packaging holder <NUM> and the identifying label can be designed with tamper evident features. Once the primary packaging holder <NUM> has been inserted into the secure and irreversible position, the primary packaging holder <NUM> cannot be removed without noticeably destroying or damaging the secondary packaging holder <NUM>. The secondary packaging holder <NUM> can accept the primary packaging holder <NUM>. The primary packaging holder <NUM> can be a vial. For example, the vial can be a frozen, un-labeled product vial. The vial can be without a label and the vial identification unique to that vial can be included on the label <NUM>. Various information about the vial and/or the vial contents can be included on the label, such as, lot number, serial number, etc..

Assembly of the primary packaging holder <NUM> into the secondary packaging holder <NUM> can be rapid and can be performed with gloved hands and/or tools. Based on the ability for the primary packaging holder <NUM> and the secondary packaging holder <NUM> to be assembled, the packaging apparatus <NUM> can allow for the allowable temperature exposure time for a drug product contained in the primary packaging holder <NUM> to not be exceeded. The plurality of vials can be at a site of secondary packaging and distribution. The assembly process can allow for advantages. With regard to supply chain, first, the packaging apparatus can move labelling operations outside a predetermined manufacturing time window. For example, a predetermined manufacturing time window can be three hours. Next, labeling can be co-located with the secondary packaging holder <NUM> and can be applied at the same time as the secondary packaging holder <NUM> receives the primary packaging holder <NUM>. Through the inventive principles described herein, investment of specialized labeler/robotics and serialization equipment and/or other machinery can be avoided or mitigated. Additionally, segregation of country-specific labeled product during long-term storage can be avoided or mitigated.

The packaging apparatus has additional commercial and regulatory advantages as well. For example, labeling for specific markets can occur closer to a customer. The labeling can be better aligned with forecast/orders and can allow for more flexibility for demand changes. Further, a label can be designed to meet country-specific regulatory and language requirements. Thus, the packaging apparatus can be multi-functional, can be user-friendly, and can include distinguished branding.

The packaging apparatus <NUM> allows for increased surface area for labeling. Further, the packaging apparatus <NUM> by having a substantially planar surface for which to affix the identifying label can provide for an improved label adhesion at room temperature. The identifying label that the packaging apparatus is configured to affix can meet country-specific regulatory and language requirements for all markets. Information on the label can take on various forms including, for example, text and/or machine readable code, sensors, etc. The identifying label can be adhesive. Alternatively, the identifying label can be printed directly onto the substantially planar surface. Labeling of the secondary packaging holder can be performed either manually or in an automated way.

The packaging apparatus <NUM> allows for a customizable, injection mold design where many sizes and style options are possible. The shape of the packaging apparatus can leverage cryo-cart or similar environment through an assembly operation for the handling of frozen drug product. Rapid, manual operation can be utilized to limit product exposure to ambient temperatures. Small, customized "batch operations" can be utilized using the packaging apparatus to fulfill regional orders as needed. The vial can be permanently secured in the secondary packaging holder by means of a quick, "snap-fit" assembly. The snap-fit assembly may consist of the secondary packaging holder having shoulders that irreversibly snap fit at a neck <NUM> of a primary packaging holder <NUM>. Other portions of the secondary packaging holder <NUM> and primary packaging holder <NUM> interacting are possible as well, including, for example, the base of the secondary packaging holder snapping into the bottom portion of the primary packaging holder <NUM>. The base of the secondary packaging holder <NUM> can provide for a stable presentation of the packaging apparatus <NUM>. The stable presentation can result from a lower center of gravity, for example, caused by a weight of the base. <FIG> shows an exploded representation of a primary packaging holder <NUM> outside of a secondary packaging holder <NUM>.

<FIG> shows a side view of the packaging apparatus <NUM>. <FIG> shows that the primary packaging holder <NUM> is in a received position of the secondary packaging holder <NUM>. As can be seen, the at least one substantially planar walls <NUM> can be in a rectangular shape that extends from a side of the base of the first end <NUM> to the second end <NUM>.

<FIG> shows a cross section of <FIG>. As can be seen from <FIG>, primary packaging holder <NUM> can make contact with a substantial portion of its exterior surface with an interior surface of the secondary packaging holder <NUM>. The secondary packaging holder <NUM> can include two substantially planar walls <NUM>.

<FIG> shows an embodiment of the invention. <FIG> shows a packaging system <NUM> for housing a sterile product that can include a secondary packaging holder <NUM> having a primary packaging holder-receiving portion <NUM> at a first end <NUM>. The secondary packaging holder <NUM> can be configured to securely and irreversibly hold a portion of a primary packaging holder <NUM> that is configured to hold a sterile product. The packaging system <NUM> can also include a tertiary packaging holder <NUM> having a base <NUM> and having a secondary packaging holder receiving portion <NUM> at an opposing end <NUM> to the base <NUM>. The tertiary packaging holder can be configured to receive and securely and irreversibly hold the secondary packaging holder.

The tertiary packaging holder <NUM> can include at least one substantially planar wall <NUM> extending from the base <NUM> to the opposing end <NUM> of the tertiary packaging holder <NUM>. The at least one substantially planar wall <NUM> can have an exterior surface configured to affix an identifying label thereto. In one embodiment, the tertiary packaging holder <NUM> can have two substantially planar walls <NUM>.

When the primary packaging holder <NUM> is securely and irreversibly held, the primary packaging holder <NUM> can have a portion exposed outside of the secondary packaging holder <NUM> based on a height relationship between the secondary packaging holder <NUM> and the primary packaging holder <NUM>. This can allow for the secondary packaging holder <NUM> to not interfere with the integrity of the cap <NUM> of the primary packaging holder <NUM>. Cap <NUM> attaches to the top end <NUM> of primary packaging holder <NUM>. The height relationship between the secondary packaging holder <NUM> and the primary packaging holder <NUM> can also allow for the secondary packaging holder <NUM> to interfere with removal of the cap <NUM>. In one embodiment, a height of the secondary packaging holder <NUM> can be approximately the same as a height of the tertiary packaging holder <NUM>.

The primary packaging holder receiving portion <NUM> can have a region <NUM> with at least a portion of an interior surface having an arc-shape. The region <NUM> can be configured to receive and hold a primary packaging holder having a cylindrical primary packaging holder. In one embodiment, the primary packaging holder can be a vial that houses a sterile product.

The secondary packaging holder <NUM> can be made of plastic or other sturdy and resilient materials. The secondary packaging holder <NUM> can be transparent or opaque. The secondary packaging holder <NUM> can have a base <NUM> at a second end <NUM> opposite to the first end <NUM>, and at least one substantially planar wall <NUM> that extends from the first end <NUM> to the second end <NUM> of the secondary packaging holder <NUM>.

The tertiary packaging holder <NUM> can be made of plastic or other sturdy and resilient materials. The tertiary packaging holder <NUM> can be transparent or opaque. The base <NUM> of the tertiary packaging holder <NUM> can be rectangular and the at least one substantially planar wall <NUM> of the tertiary packaging holder <NUM> can extend from at least one side of the base <NUM>.

The at least one substantially planar wall of the tertiary packaging holder <NUM> can extend from the base <NUM> to the opposing end <NUM> of the tertiary packaging holder <NUM>. An interior surface of the at least one planar wall <NUM> of the tertiary packaging holder <NUM> can contact an exterior surface of the at least one surface of the secondary packaging holder <NUM>.

In one embodiment, two substantially planar walls <NUM> of the tertiary packaging holder <NUM> can extend from respective sides of the rectangular base <NUM> to the secondary packaging holder receiving portion <NUM>. Further, two substantially planar walls <NUM> of the secondary packaging holder <NUM> can extend from the respective sides such that interior surfaces of the two substantially planar walls <NUM> of the tertiary packaging holder <NUM> can contact exterior surfaces of the two substantially planar walls <NUM> of the secondary packaging holder <NUM> in a received position.

In one embodiment, two non-planar walls <NUM> of the tertiary packaging holder <NUM> can extend from other respective sides of the rectangular base <NUM> to the secondary packaging holder receiving portion <NUM>. Each of the non-planar walls <NUM> of the tertiary packaging holder <NUM> can outline an aperture <NUM> in a middle section of the non-planar wall <NUM>. Spacings <NUM> in between the two planar walls <NUM> of the secondary packaging holder <NUM> can overlap with the apertures <NUM> of the tertiary packaging holder <NUM> when the secondary packaging holder <NUM> is securely and irreversibly held. The overlapped apertures and spacings allowing for direct access through the walls on the side to the primary packaging holder when the primary packaging holder <NUM> is securely and irreversibly held in the secondary packaging holder <NUM> and the tertiary packaging holder <NUM>. Thus, the apertures can allow for direct access to at least a portion of a side of the primary packaging holder <NUM> when the primary packaging holder <NUM> is securely and irreversibly held in the secondary packaging holder <NUM> and tertiary packaging holder <NUM>.

The spacings <NUM> of the secondary packaging holder <NUM> can extend from the primary packaging holder receiving portion <NUM> to a lip <NUM> on the base. The base <NUM> of the secondary packaging holder <NUM> along each of the spacings <NUM> can include a lip <NUM> that borders the base <NUM> and that extends along the longitudinal axis in between the planar surfaces. The lips of the secondary packaging holder <NUM> can be configured to contact an interior surface <NUM> of substantially arc-shaped walls of the tertiary packaging holder <NUM>. In some embodiments, the secondary packaging holder <NUM> can be configured to snap fit into the tertiary packaging holder <NUM>.

The primary packaging holder can be a necked cylinder, and the secondary packaging holder can have shoulders configured to irreversibly snap fit at a neck <NUM> of the primary packaging holder <NUM>. Other portions of the secondary packaging holder <NUM> and primary packaging holder <NUM> interacting are possible as well, including, for example, the base of the secondary packaging holder snapping into the bottom portion of the primary packaging holder <NUM>.

The packaging unit can include a sealable port <NUM> configured to enclose an interior space of the primary packaging holder when sealed. The secondary and tertiary packaging holders permit direct access to the interior space via the sealable port <NUM>.

<FIG> shows that a packaging apparatus <NUM> for housing a sterile product can include a substantially cylindrical vial holder <NUM> having a receiving portion <NUM> at a first end <NUM> and a base <NUM> at a second opposing end. The packaging apparatus <NUM> can include a label stand <NUM> that is adjacent to the substantially cylindrical vial holder <NUM>. The label stand <NUM> can have a cross-section shape that is different than a cross-section shape of the cylindrical vial holder. For example, rather than having a circular cross-section, the label stand <NUM> can be a substantially non-uniform cross-section shape. As can be seen from <FIG>, a portion of the label stand <NUM> cross-section shape can share an edge with the cylindrical vial holder portion. Thus, the label stand <NUM> cross section can be concave.

When the primary packaging holder <NUM> is securely and irreversibly held, the primary packaging holder <NUM> can have a portion <NUM> exposed outside of the secondary packaging holder <NUM> based on a height relationship between the secondary packaging holder <NUM> and the primary packaging holder <NUM>. This can allow for the secondary packaging holder <NUM> not to interfere with the integrity of cap <NUM> of the primary packaging holder <NUM>. The height relationship between the secondary packaging holder <NUM> and the primary packaging holder <NUM> can also allow for the secondary packaging holder <NUM> to interfere with removal of the cap <NUM>.

The packaging apparatus <NUM> can include lock-in units <NUM> that are disposed on an interior surface of the receiving portion <NUM>. The lock-in units <NUM> can be configured to lock in a vial <NUM> (see <FIG>) once the vial <NUM> has been inserted into the cylindrical vial holder a predetermined amount. For example, a predetermined amount can be until the vial has been inserted up until a neck <NUM> of the cylinder. Through the lock-in units <NUM>, the vial <NUM> can be snap fit into the cylindrical vial holder <NUM>.

The substantially cylindrical vial holder <NUM> can have a height h that allows for a user to remove a vial holder lid after the vial has been locked-in.

The label stand <NUM> can be formed by a first wall <NUM> that is integral with the cylindrical vial holder <NUM> and that extends in a tangential plane from a longitudinal line at a first point along the cylindrical vial holder and a second wall <NUM> that is integral with the cylindrical vial holder and that extends in a tangential plane from a longitudinal line at a substantially opposing point than the first point along the cylindrical vial holder <NUM>. Exterior surfaces of the first and second walls <NUM>, <NUM> can include at least one substantially planar labelling surface <NUM> configured to affix an identifying label <NUM> thereto. The first and second walls <NUM>, <NUM> can join in a substantially rounded manner forming an arc-shaped curve. The arc-shaped curve can have a circular portion that has a smaller arc-length than an arc-length of the cylindrical vial holder.

<FIG> shows an exploded view of the secondary packaging holder, and <FIG> shows an alternative perspective of the exploded view of <FIG>. While <FIG> show label <NUM>, it is to be understood that this is for illustrative purposes only and that label <NUM> is not part of the secondary packaging holder.

In another embodiment, <FIG> shows a method of packaging a sterile product. The method can include in step S <NUM> providing a primary packaging holder. The primary packaging holder can have a sterile interior space and a sealable port. The method can include step S120 depositing a sterile product. The step S120 can include depositing into the interior space through the port. The method can include S130 sealing the port. The port can be sealed by securing a cap on the primary packaging holder. The method can further include S <NUM> receiving the primary packaging holder through a receiving portion of a secondary packaging holder. The method can further include S150 snapping fit the primary packaging holder to the secondary packaging holder. The steps S140 and S150 can be such that the secondary packaging holder securely and irreversibly holds the primary packaging holder. The method can further include S160 receiving the secondary packaging holder through a receiving portion of a tertiary packaging holder. The step S160 can be such that the tertiary unit securely and irreversibly holds the secondary unit. The tertiary packaging holder can include a substantially planar exterior surface that is configured to affix an identifying label thereto. The method can include S170 snapping fit the secondary packaging holder to the tertiary packaging holder.

The method can further include step S180 affixing a label to the tertiary packaging holder. The method can further include affixing an identifying label to the substantially planar exterior surface of the tertiary packaging holder. The exterior surface can be substantially planar. The identifying label can be an adhesive label.

The depositing a sterile product in the interior space can take place after securing the primary packaging holder to the secondary packaging holder. The depositing a sterile product in the interior space can also occur after securing the secondary packaging holder to the tertiary packaging holder.

<FIG> show alternative packaging apparatuses. As shown in <FIG>, the packaging apparatus <NUM> can include a secondary packaging holder <NUM> that is configured to hold a primary packaging holder <NUM>. The secondary packaging holder <NUM> can have a substantially cuboid exterior shape. The secondary packaging holder <NUM> can be made of two halves 119A and 119B that can connect by means of a hinge pin <NUM> near a base <NUM> of the secondary packaging holder <NUM>. As seen from <FIG>, the base <NUM> can be square-shaped. The hinge pin <NUM> can be used to lock the two halves together. Various configurations are contemplated for locking the two halves together using the hinge pin such as, for example, pressing the two halves together or by pressing the hinge pin, for example, by a user. The secondary packaging holder <NUM> can have a circularly-shaped opening near a top portion to snap fit to a neck <NUM> of the body and lid <NUM> of the primary packaging holder <NUM>.

The secondary packaging holder <NUM> can include one surface <NUM> that may be substantially planar. The surface <NUM> can be configured such that a label <NUM> can adhere thereto. The secondary packaging holder <NUM> can outline an aperture <NUM> on one or more sides from the base <NUM> to the receiving portion <NUM>.

As shown in <FIG>, the packaging apparatus <NUM> can include a secondary packaging holder <NUM> that has a circular base <NUM> and a circular receiving portion <NUM>. The base <NUM> can have an outer diameter that substantially conforms to the outer diameter of a primary packaging holder <NUM>. Similarly, the receiving portion <NUM> can have an outer diameter that substantially conforms to the outer diameter of the primary packing holder <NUM>. The circular base <NUM> can have a lower rim <NUM> and an upper rim <NUM>. The secondary packaging holder <NUM> can connect the base <NUM> to a receiving portion <NUM> by means of a connecting portion <NUM>. The connecting portion <NUM> can extend outwardly from the base and have a generally planar portion configured to receive a label <NUM> thereto. Thus, when inserted, a gap between the primary packaging holder <NUM> and the single portion <NUM> of the secondary packaging holder <NUM> can be more pronounced than the distance between the regions near the receiving portion <NUM> and the base <NUM>.

The secondary packaging holder <NUM> can outline an aperture <NUM> around a majority of the secondary packaging holder <NUM> from the base <NUM> to the receiving portion <NUM>. After receiving the primary packaging holder <NUM>, the secondary packaging holder <NUM> can secure the primary packaging holder <NUM> by means of a ratchet pin <NUM>. Various configurations are contemplated for locking the secondary packaging holder <NUM> using the ratchet pin. The ratchet pin <NUM> can work by snapping the pin to lock, for example, by a user. For example, the ratchet pin <NUM> can be located at the receiving portion <NUM>.

As shown in <FIG>, the packaging apparatus <NUM> can include a secondary packaging holder <NUM> that has a circular base <NUM> and a circular receiving portion <NUM>. The circular base <NUM> has a diameter that is substantially larger than a diameter of a primary packaging holder <NUM> that is configured to be received therein. Similarly, the receiving portion <NUM> can have a diameter that is substantially larger than the outer diameter of the primary packaging holder <NUM>. The secondary packaging holder <NUM> can connect the base <NUM> to the receiving portion <NUM> by means of at least one side panel <NUM>. The secondary packaging holder <NUM> can be configured such that at least one aperture <NUM> is formed between the base <NUM> and the receiving portion <NUM>.

The receiving portion can include a substantially planar region <NUM> that is configured to receive at least one label <NUM>. The base <NUM> can include crush ribs <NUM> that can allow for the secondary packaging holder <NUM> to securely and tightly fit the primary packaging holder <NUM>. Various configurations are contemplated for locking the secondary packaging holder <NUM>. For example, the primary packaging holder <NUM> can be pushed to interact with the crush ribs and thus lock the primary packaging holder <NUM> inside the secondary packaging holder <NUM>.

As shown in <FIG>, the packaging apparatus <NUM> can include a secondary packaging holder <NUM> that has a circular base <NUM> and a circular receiving portion <NUM>. The base <NUM> can have an outer diameter that substantially conforms to the outer diameter of a primary packaging holder <NUM>. Similarly, the receiving portion <NUM> can have an outer diameter that substantially conforms to the outer diameter of the primary packing holder <NUM>. The secondary packaging holder <NUM> can connect the base <NUM> to the receiving portion <NUM> by means of at least one side panel <NUM>. The secondary packaging holder <NUM> can be configured such that at least one aperture is formed between the base <NUM> and the receiving portion <NUM>.

Towards the receiving portion <NUM>, as seen from <FIG>, a region <NUM> that spans at least a portion of a surface of the secondary packaging holder <NUM> can be configured to adhere at least one label <NUM> thereto. The secondary packaging holder <NUM> can have flex arms that slide and snap to lock the secondary packaging holder <NUM>. Various configurations are contemplated of using the flex arms to slide and snap to lock, thus securely and tightly fitting the primary packaging holder <NUM> inside the secondary packaging holder <NUM>.

As shown in <FIG>, the packaging apparatus <NUM> can include a secondary packaging holder <NUM> that has at least a partially circular base <NUM> and at least a partially circular receiving portion <NUM>. The secondary packaging holder <NUM> includes a stand <NUM> that projects outwardly from a side of the secondary packaging holder <NUM>. The stand <NUM> can include at least one buttons or locking mechanisms <NUM> that are configured to be snapped to lock the primary packaging holder <NUM> inside the secondary packaging holder <NUM>. The stand <NUM> can include at least one substantially planar surface <NUM> that is configured to receive at least one label <NUM>.

Claim 1:
A packaging system (<NUM>) for housing a sterile product comprising:
a secondary packaging holder (<NUM>) having a primary packaging holder (<NUM>) receiving portion (<NUM>) at a first end (<NUM>), the secondary packaging holder (<NUM>) being configured to securely and irreversibly hold a portion of a primary packaging holder (<NUM>) comprising a necked (<NUM>) cylinder that is configured to hold a sterile product; and
a tertiary packaging holder (<NUM>) having a base (<NUM>) and having a secondary packaging holder receiving portion (<NUM>) at an opposing end (<NUM>), the tertiary packaging holder (<NUM>) being configured to receive and securely and irreversibly hold the secondary packaging holder (<NUM>),
wherein the tertiary packaging holder (<NUM>) includes at least one substantially planar wall (<NUM>) extending from the base (<NUM>) to the opposing end (<NUM>) of the tertiary packaging holder (<NUM>), the substantially planar wall (<NUM>) having an exterior surface configured to affix an identifying label thereto,
wherein the secondary packaging holder (<NUM>) has shoulders (<NUM>) configured to irreversibly snap fit at the neck (<NUM>) of the primary packaging holder (<NUM>).