Patent Description:
Sterile "cleanroom" environments demand that any person or item entering the room be free of a certain level of contaminants. Sterilized environments are most commonly designed for use in manufacturing facilities and medical research and treatment facilities in the pharmaceutical, biotechnology, and healthcare industries, to name a few. Sterile cleanroom environments may be classified under a variety of classification schemes, including the International Organization of Standardization ("ISO") Cleanroom Standards, whereby the highest level of sterilization is an ISO <NUM> cleanroom, and normal ambient air (no sterilization) is classified as ISO <NUM>. The ISO standards correspond to the allowed number of particles having a minimum particle size per cubic meter. For example, an ISO <NUM> cleanroom allows the following: a maximum of <NUM>,<NUM> particles with a particle size greater than <NUM>; a maximum of <NUM>,<NUM> particles greater than <NUM>; a maximum of <NUM>,<NUM> particles greater than <NUM>; a maximum of <NUM>,<NUM> particles greater than <NUM>; a maximum of <NUM> particles greater than <NUM>; and a maximum of <NUM> particles greater than <NUM>.

A variety of products are utilized inside cleanroom environments, including paper and paper products used to document manufacturing and testing records within the controlled areas. Such paper products include, but are not limited to, forms, logbooks, tags and batch records. All of these documents are necessary to detail the manufacturing and testing processes so as to ensure that proper procedures are followed and results are documented. Indeed, these documents are subject to review by regulatory agencies, such as the U. Food and Drug Administration, and represent the mechanism by which such agencies can review the manufacturing and testing process details after the manufacture, testing, or handling of a drug product, for example, to assure patient safety.

However, paper and paper products are a significant contamination source due to shedding fibers, particulates and microorganisms (e.g., bacillus and mold). About <NUM>% of paper products used in sterile environments are standard documents that can be pre-printed, packaged and sterilized by known means. However, the remainder of the documents introduced into sterile environments cannot be pre-printed, sterilized and packaged in a timely fashion. Their preparation requires information that is not readily available until days, or even hours, before the manufacturing or testing is to begin. In some instances, they must be prepared while manufacturing and/or testing is underway. Because of this, these documents are forced to be brought into sterilized areas without prior treatment for the reduction of shedding fibers, particulates and microorganisms. Thus, they represent a significant contamination source.

To solve this problem, the invention provides for a portable cleanroom printing cabinet which allows documents to be printed in sterile environments without the introduction of any outside contaminants. <CIT> discloses a portable printing cabinet with a printing device located within its interior, with hinged covers and a paper tray in its top surface for accessing the printing device and depositing printed paper, respectively.

Accordingly, the invention provides a printing cabinet according to the claims.

A more complete appreciation of the invention and many of the attendant advantages thereof will be readily obtained as the same becomes better understood by reference to the following detailed description when considered in connection with the accompanying drawings, wherein:.

Referring to <FIG>, the portable printing cabinet <NUM>, not falling within the scope of the claims, allows the printing of documents within a controlled, cleanroom environment onto sterilized paper at high speeds. This cabinet reduces or eliminates the presence of bioburden (e.g., microorganisms such as bacillus and mold) on printed documents. The printing cabinet <NUM> further assures that particulates and shedding fibers from the paper is minimized or eliminated. The printing cabinet <NUM> may be used in any ISO level controlled area, including cleanrooms at an ISO <NUM> level or lower.

As shown in <FIG>, the printing cabinet <NUM> generally includes a housing <NUM> having at least four sides and a bottom <NUM>. In the embodiment shown, the four sides are formed of thin rectangular-shaped panels and include a left side <NUM>, front side <NUM>, right side <NUM>, and back side <NUM>. The sides <NUM>, <NUM>, <NUM> and <NUM> are preferably joined with the bottom <NUM> of the housing <NUM> to form a substantially rectangular box-shaped cabinet <NUM>. Preferably, the housing <NUM> forms an enclosure that defines an interior space. Cross-member <NUM> may connect the front side <NUM> of the housing <NUM> to the back side <NUM> of the housing <NUM>. The cabinet <NUM> may be supported by any structure known in the art. As shown in <FIG>, the cabinet <NUM> is supported by a plurality of wheels <NUM> fixed to the bottom <NUM>. The use of wheels <NUM> allows the cabinet <NUM> to be moved out of the cleanroom when necessary for cleaning or sterilization treatment. Legs may also be used if the cabinet <NUM> does not need to be moved from one location to another.

The housing <NUM> may be formed of any durable material which can store a printing device and other items, and which prevents the passage of fluids or air into the interior of the cabinet <NUM>. Indeed, the housing <NUM> preferably forms a sealed unit (with covers <NUM> and <NUM>) such that contaminants cannot escape. According to one embodiment, the entire housing <NUM> is formed of stainless steel. According to another embodiment, other durable metals or plastic materials may be used. Metals are preferred such that sterilization of the unit can be performed by an autoclave or other similar devices.

Referring now to <FIG>, a cross-section is shown of the printing cabinet <NUM> taken along line <NUM>-<NUM> of <FIG>. An interior shelf <NUM> may be provided that divides the cabinet <NUM> into an upper portion <NUM> and a lower portion <NUM>. In one embodiment, the interior shelf <NUM> is welded to sides <NUM>, <NUM>, <NUM> and <NUM> of the housing <NUM> to form a complete assembly. The upper portion <NUM> houses a printing device <NUM>, which can be placed on the interior shelf <NUM>. Any printing device known in the art may be used. High-grade printers which emit the lowest level of particulates, reduce shedding, and reduce ink droplet release, are preferred. According to one embodiment, the CDT <NUM> printer manufactured by Colordyne Technologies LLC of Brookfield, Wisconsin, which may include MEMJET® printing technology, may be used. However, it will be appreciated that any suitable or standard printer can be utilized.

The upper portion <NUM> of the cabinet <NUM> may also house an air filtration unit <NUM> having a fan aligned with exterior vents <NUM> positioned on at least one side of the housing <NUM> (see <FIG>). Any filtration unit known in the art may be used, though preferable that the unit achieves a filtration rate of <NUM>%. More specifically, the unit <NUM> must filter air from the interior of the cabinet <NUM> at a rate of <NUM>% with respect to <NUM> micron particles. According to one embodiment, a high-efficiency particulate air ("HEPA") filtration unit may be used. The fan of the air filtration unit <NUM> blows air out of the cabinet through the filter. This maintains the cabinet <NUM> under negative pressure, via the exterior vents <NUM>, such that the risk of transmission of particles to the exterior environment is minimized. Thus, if a door <NUM> or <NUM>, or a cover <NUM> or <NUM>, is opened, the fan will suck air into the housing interior, preventing particles from escaping. In addition, the interior shelf <NUM> may have vents (not shown) which permit equalization of the pressure in the cabinet <NUM> between the upper portion <NUM> and the lower portion <NUM>.

According to a preferred embodiment, at least one hinged cover is fixed to the housing <NUM> of the cabinet <NUM> so as to enclose the upper portion <NUM> and still allow for easy access to the interior of the housing <NUM>, such as to access the printing device <NUM>. As shown in <FIG>, the upper portion <NUM> is enclosed by two adjacent hinged covers <NUM> and <NUM> having a generally triangular cross-section. Specifically, hinged covers <NUM> and <NUM> may each have angled edges <NUM> which engage the front side <NUM> and back side <NUM> of the housing <NUM>. The front cover <NUM> may be hinged to cross-member <NUM> of the housing <NUM> along one lateral side <NUM> that extends transversely across from side <NUM> to side <NUM>. Any method of hinging one member to another member may be used, including piano style mechanical hinges or the inclusion of a polymer strip (e.g., polypropylene) between the cover <NUM> and the cross-member <NUM> along side <NUM>. While the air filtration unit <NUM> adequately maintains the interior of the cabinet <NUM> under negative pressure so as to minimize the risk of contamination, gaskets or rubber seals may optionally be utilized between the hinged covers <NUM> and <NUM> and the housing <NUM> (on any side) to further ensure contamination protection.

The front cover <NUM> may include a paper tray <NUM> on an outer surface for receiving printed documents. In another embodiment, the paper tray <NUM> need not be on the front cover <NUM>, but may be separate from the housing <NUM> and attached thereto. Alternatively, the printed paper may be ejected from an opening in the housing <NUM> located on any side adjacent to the end of the printing device <NUM> (see <FIG> and <FIG>).

As seen in <FIG>, the printing device <NUM> may include a paper guide <NUM> extending from an end thereof. The paper guide <NUM> may be a C-shaped paper dispensing guide having a plurality of rollers <NUM> along its length. In one embodiment, the paper guide <NUM> is a half circle with a radius of between <NUM> and <NUM> inches, such that a variety of paper sizes may be accommodated. When the printed paper is expelled from the printing device <NUM>, it is moved along by the rollers <NUM> on the paper guide <NUM> in direction "A. " The paper guide <NUM> guides the paper upward to be received in the paper tray <NUM>, which is then accessible without needing to lift the front cover <NUM> to access the printing device <NUM>. In this way, the paper guide <NUM> transfers the paper from the printing device <NUM>, inside of the housing <NUM>, to the paper tray <NUM>, outside of the housing <NUM>. The printed paper should be ejected from the printing device <NUM> with a force sufficient to push the paper along the rollers <NUM> of the paper guide <NUM> and deposited into paper tray <NUM> above. In one embodiment, a gear-driven assembly having a motor (not shown) may be used to rotate the rollers to thereby push or pull the printed paper along the paper guide <NUM>. The front cover <NUM> includes an opening <NUM> in communication with the paper tray <NUM> so as to allow the printed paper to pass through. Specifically, the paper guide <NUM> is connected to the top of the opening <NUM> in the front cover <NUM> such that the paper can be deposited into the paper tray <NUM> on top of any paper previously printed. The front cover <NUM> only needs to be lifted if the printing device <NUM> experiences a paper jam or lodged paper needs to be removed from the paper guide <NUM>. The front cover <NUM> may include a handle <NUM> designed for use by an individual wearing a protective glove.

The rear cover <NUM> may be configured similarly to the front cover <NUM>. The rear cover <NUM> may be used to feed paper into the printing device <NUM>. Specifically, the rear cover <NUM> may be hinged to cross-member <NUM> of the housing <NUM> along a lateral side <NUM> opposite the side connected to the front cover <NUM>. The hinging mechanism may be similar to those used with the front cover <NUM>, as discussed above. The rear cover <NUM> may have a handle <NUM>, which is designed for use by an individual wearing a protective glove. The opened first and second covers <NUM> and <NUM>, respectively, are illustrated in <FIG>.

The left side <NUM> of the housing <NUM> may include one or more doors <NUM> (one is illustrated in <FIG>) for access to the printing device <NUM> and upper portion <NUM> of the printing cabinet <NUM>. Specifically, while not limited to such an embodiment, the door <NUM> may be used for printer cartridge replacement. Because high-quality printing devices are preferred, numerous printing cartridges may need to be used and replaced often. The user may access the printing device <NUM> to replace printing cartridges by opening the door <NUM>, as shown in <FIG>. While the door <NUM> is depicted on the left side <NUM> of the cabinet <NUM> in <FIG> and <FIG>, it may be positioned on any side of the cabinet <NUM> which allows access to the printing device <NUM> (e.g., front side <NUM>). Like the front and rear covers <NUM> and <NUM>, respectively, gaskets or rubber seals may optionally be utilized between door <NUM> and the housing <NUM> to further ensure contamination protection.

As shown in <FIG>, the right side <NUM> of the housing <NUM> may include ports for the connection of a data cable and/or power cable. Specifically, two data connection ports <NUM> and one power outlet <NUM> are shown, although any number of ports may be present for various purposes. According to another embodiment, the ports <NUM> and outlet <NUM> may be provided on any side of the cabinet <NUM>. The data connection ports <NUM> and outlet <NUM> may be present on both the outside of the housing <NUM> (as shown in <FIG>) and the inside of the housing <NUM> for connection to the printing device <NUM> or any other devices inside the cabinet <NUM>. Specifically, the printing device <NUM> and other electronics may be plugged into the power outlet <NUM>, for example, from the inside of the housing <NUM>. From the outside of the housing <NUM>, an AC electrical power cord, which is plugged into a power source, may then be plugged into the power outlet <NUM>. As shown in <FIG>, the power outlet <NUM> on the outside of the housing <NUM> is a male connector (with two or three prongs) that is inset into the housing <NUM> so as to protect it from damage. At the interior of the housing <NUM>, the outlet <NUM> is a female receptacle to accept the power plugs from the printing device <NUM> and other electrical components. The placement of ports <NUM> and power outlet <NUM> on the exterior surface of the cabinet <NUM> are advantageous in that the doors <NUM> (discussed below) need not be opened in order to plug and unplug the printing device <NUM>, such as when the cabinet <NUM> is moved from one location to another.

As a portable unit, the cabinet <NUM> may operate on either AC electrical power (i.e., 110V AC in the U. or 220V AC globally) or battery power. In one embodiment, a battery (not shown) is located within the lower portion <NUM> of the cabinet <NUM> and is electrically connected to the power outlet <NUM>. The battery may be of a type that would power the printing device <NUM> and one or more air filtration units <NUM> for a period of up to six hours. When not in use, the battery may be charged via electrical power delivered through the outlet <NUM>.

The lower portion <NUM> of the printing cabinet <NUM> is located below the interior shelf <NUM> and may be used for storage of miscellaneous items such as sterilized paper. The lower portion <NUM> may be accessible to a user via one or more doors <NUM> fixed to any of the side(s) of the cabinet <NUM>. As shown in <FIG> and <FIG>, the lower portion <NUM> has two doors <NUM> fixed to the front side <NUM> of the cabinet <NUM>, although more than two doors may be included. The lower portion <NUM> may also house an air filtration unit (not shown) similar to the filtration unit <NUM> housed in the upper portion <NUM>. As discussed herein, gaskets or seals may be utilized between the outer periphery of the door(s) <NUM> and the housing <NUM> to further ensure contamination protection.

In an alternative embodiment (not shown), the housing <NUM> is substantially enclosed, such that it has no openings or doors, except opening <NUM> where the printed paper passes into the paper tray <NUM>. The presence of the air filtration unit <NUM> within the housing <NUM> maintains negative pressure within the cabinet <NUM>, such that protection against contamination is ensured.

In practice, the printing device <NUM> and air filtration unit(s) <NUM> may be controlled via a wireless connection or hard wire connection to a network. According to one embodiment where hard wiring is used, a USB cable or an Ethernet cable may be connected from the PC to the ports <NUM>, and then another cable may be connected from ports <NUM> to the printing device <NUM> on the inside of the housing <NUM>. In another embodiment, any known wireless communication methods may be used, including, but not limited to, WiFi and Bluetooth® capabilities. Control of the printing device <NUM> may be accomplished within the cleanroom by any known wireless or wired devices, including, but not limited to, a network computer, an iPad®, a PC, or a laptop computer. When it receives a signal, the printing device <NUM> prints the required document and expels it into the paper tray <NUM> for collection by a user. The motor can activate the rollers <NUM>, for instance, when the printing device <NUM> is activated. In an embodiment, the motor can have a wireless or wired connection and can receive the same signal as the printing device <NUM>.

To further ensure the sterility of the cleanroom environment, the printing device <NUM> prints onto pre-sterilized paper. Any methods of sterilizing the paper known to one skilled in the art may be used, including, but not limited to, steam, heat, chemical treatment, or gamma irradiation. Preferably, a non-shedding paper product is used. In one embodiment, a plastic, non-shedding printing medium, such as Teslin® manufactured by PPG Industries of Pittsburgh, Pennsylvania, may be used. However, any suitable paper or printing medium can be used. The paper or printing medium may be provided on rolls at a predetermined length, or it may be provided as cut sheets prepared in ream. As set forth above, this paper may be stored in the lower portion <NUM> of the cabinet <NUM> when not in use.

The printing cabinet <NUM> is fully portable. All contents located within the cabinet <NUM> (e.g., printing device <NUM>, air filtration unit <NUM>) are enclosed within the housing <NUM>. The printing cabinet <NUM> can be wheeled to other locations and plugged into any standard AC power source.

An embodiment of a portable printing cabinet <NUM> in accordance with the present invention is illustrated in <FIG> and <FIG>. In this embodiment, the printing cabinet <NUM> and its housing <NUM> generally have the same structure as printing cabinet <NUM>, including at least four sides and a bottom surface, but the upper portion <NUM> of housing <NUM> has a different shape and design. Like cabinet <NUM>, printing cabinet <NUM> is supported by a plurality of wheels <NUM> fixed to its bottom surface <NUM>, which allows the cabinet <NUM> to be moved out of the cleanroom when necessary for cleaning or sterilization treatment. The housing <NUM> may be formed of the same material(s) as housing <NUM> and should form an enclosed unit to prevent contaminants from escaping.

The interior of the printing cabinet <NUM> is arranged similarly to the interior of cabinet <NUM>, wherein an interior shelf <NUM> is provided that divides the cabinet <NUM> into an upper portion <NUM> and lower portion <NUM>. The interior shelf <NUM> may be coupled to the housing <NUM> in the same manner as interior shelf <NUM> is to housing <NUM>, as set forth above. The upper portion <NUM> houses the printing device <NUM> which is positioned on the interior shelf <NUM>. The lower portion <NUM> may house at least one air filtration unit <NUM> aligned with vents <NUM> positioned on the outside of at least one side of the housing <NUM>. The lower portion <NUM> may further include doors <NUM> on a front surface <NUM> thereof that allow for easy access to the storage area within the lower portion <NUM> and the air filtration unit <NUM>.

In one embodiment, the upper portion <NUM> and lower portion <NUM> are designed as separate and discrete housings, each having a top, bottom, and four sides generally forming a substantially rectangular shape. The lower portion <NUM> can act as a base unit that supports the upper portion <NUM>. The upper portion <NUM> can act as a printer unit that sits on the lower portion <NUM> and houses the printing device <NUM>. In another embodiment, the lower portion <NUM> is optional and the upper portion <NUM> may house all components, including the printing device <NUM> and the at least one air filtration unit <NUM>, and be supported by legs (not shown).

As shown in <FIG>, the upper portion <NUM> has a top surface <NUM> and two opposing ends <NUM> and <NUM>. The top surface <NUM> has a raised or step-up portion <NUM> (see <FIG>) adjacent to end <NUM>. The step-up portion <NUM> is raised because that end <NUM> receives the larger paper loading section of the printing device <NUM> which allows for large volumes of paper to be received therein.

Part of the step-up portion <NUM> is formed by at least one hinged cover <NUM>, which is fixed to the housing <NUM> and encloses the upper portion <NUM> while allowing for easy access to the printing device <NUM>. As best shown in <FIG>, the hinged cover <NUM> may be hinged to the housing <NUM> using any rotatable attachment mechanism know in the art, including piano style mechanical hinges. When the hinged cover <NUM> is lifted using the handle <NUM>, access to the printing device <NUM> is provided so as to allow a user to feed paper into the printing device <NUM>, fix paper jams, and the like.

The hinged cover <NUM> generally has an "L" shape formed by two joined surfaces <NUM> and <NUM>. The top surface <NUM> forms part of the step-up portion <NUM>, and side surface <NUM> forms part of a side <NUM> of the upper portion <NUM>. The upper portion <NUM> also has an opposing side <NUM> at end <NUM>. The top surface <NUM> may include a window <NUM>, such as a glass window, so that the user can see the printing device <NUM> and ensure that it is working properly (e.g., to check paper levels) without having to open the hinged cover <NUM>. While the air filtration unit <NUM> adequately maintains the interior of the cabinet <NUM> under negative pressure so as to minimize the risk of contamination, gaskets or rubber seals may optionally be utilized between the hinged cover <NUM> and the housing <NUM> to further ensure contamination protection. A bar <NUM> is fixed to the side <NUM> of the upper portion <NUM> of the housing <NUM> to assist the user in moving the printing cabinet <NUM>.

As shown in <FIG>, a second hinged cover <NUM> forms a part of the top surface <NUM> of the upper portion <NUM> at end <NUM>. The second hinged cover <NUM> encloses the upper portion <NUM> while also allowing for easy access to the dispensing end <NUM> (i.e., where the printed document is expelled) of the printing device <NUM>. The second hinged cover <NUM> may be hinged to the housing <NUM> using any means set forth herein.

The first hinged cover <NUM> and second hinged cover <NUM> may remain in an opened position when opened by a user so that the user need not hold them in place while accessing the inside of the printing cabinet <NUM>. For example, first hinged cover <NUM> may have a bar <NUM> that holds it open and/or a slow close mechanism (not shown) to avoid the first hinged cover <NUM> from slamming down onto the housing <NUM> when closed. The second hinged cover <NUM> may also include a bar and/or slow close mechanism.

A paper tray <NUM> is coupled to the side <NUM> of the upper portion <NUM> to receive printed paper Z being expelled from the printing device <NUM> in direction Y. As shown in <FIG>, side <NUM> of the upper portion <NUM> has a generally rectangular opening <NUM> formed therein. The opening <NUM> is aligned with and in communication with the printing device <NUM>, specifically the area where the printed document is expelled from the printing device <NUM>. Since the printing device <NUM> is inside the printing cabinet <NUM>, the paper exits the printing device <NUM> and is directly expelled through the opening <NUM> to be received in the paper tray <NUM> on the outside of the printing cabinet <NUM>. In one embodiment, the paper tray <NUM> includes at least two prongs <NUM> at one end thereof. The prongs <NUM> engage the side <NUM> at the opening <NUM> and function as hooks so as to hold the paper tray <NUM> in place when the weight of paper tray <NUM> is allowed to rest on the edge of opening <NUM>. In this way, the paper tray <NUM> can be securely held in place at an angle extending toward the ground so as to allow the printed paper to slide down into the paper tray <NUM> in direction B when exiting through the opening <NUM>. The paper tray <NUM> can also be easily removed to be cleaned, replaced, or to allow access to the opening <NUM>. The paper tray <NUM> is sized and configured so as to be able to receive paper of various sizes and in large volumes. The paper tray <NUM> is generally formed of the same material used to form the housing <NUM> (e.g., stainless steel). In an alternative embodiment, the paper tray <NUM> need not be separate from the housing <NUM>, but can be a lower part of the housing <NUM>.

Claim 1:
A printing cabinet (<NUM>) for housing a printing device (<NUM>) having a dispensing end that expels printed paper, comprising:
a housing (<NUM>) having at least four sides (<NUM>; <NUM>), a bottom surface (<NUM>) and a top surface (<NUM>) that together form an enclosed interior for receiving the printing device (<NUM>) and said top surface (<NUM>) including at least one hinged cover (<NUM>; <NUM>) that encloses an upper portion (<NUM>) of the housing (<NUM>);
wherein the housing further comprises an opening (<NUM>) formed in the side (<NUM>) of the housing (<NUM>), the opening (<NUM>) aligned with the dispensing end of the printing device (<NUM>); and
the printing cabinet (<NUM>) further comprises a paper tray (<NUM>) at the side (<NUM>) of the housing (<NUM>) and positioned outside of the housing (<NUM>), said paper tray (<NUM>) aligned with the opening (<NUM>) of the housing (<NUM>) and arranged to receive the printed paper expelled by the printing device (<NUM>) wherein the paper tray (<NUM>) extends towards the ground so as to allow the printed paper to slide down into the paper tray (<NUM>).