Abstract:
A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure. The apparatus similarly allows the fluid path to be unprotected for use without the use of gloves, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontamination is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated.

Description:
TECHNICAL FIELD 
       [0001]    This document relates generally to controlled environment enclosures and in particularly to a method for protecting and unprotecting the fluid path in a controlled environment enclosure. 
       BACKGROUND 
       [0002]    Controlled environment enclosures are known in the art. Such enclosures are used, for example, for containment of hazardous materials. In other examples controlled environment enclosures are used to provide controlled environments with limited numbers of particulates. 
         [0003]    In the art controlled environment enclosures are typically fitted with ports for transfer of materials in and out of the enclosure and the ports are fitted with gloves for manual manipulation of equipment, parts or materials inside the enclosure. Such gloves are subject to significant risk of puncture. 
         [0004]    In some examples known in the art the controlled environment enclosure is also used to limit exposure to viable particulates. Such controlled environment enclosures may be required for aseptic processing of cell cultures and for the manufacture of pharmaceutical products, medical devices, food or food ingredients. In these cases it is a requirement that the controlled environment enclosure be decontaminated. This may be done thermally using steam or chemically using chemical agents. Suitable chemical agents known in the art include hydrogen peroxide, ozone, beta-propiolactone, aziridine, formaldehyde, chlorine dioxide, ethylene oxide, propylene oxide, and peracetic acid. In most cases the decontamination and sterilization operations has to be preceded by a cleaning process. Such cleaning processes have the function of removing major contamination by simple mechanical and chemical action. 
         [0005]    In some examples in the prior art the controlled environment also contains automated equipment. Such automated equipment includes machines for filling of vials. The automated equipment located in the controlled environment is typically of such a size and complexity that it cannot be operated fully automatically without human intervention. Such human intervention typically requires the use of gloves with the associated risk of puncture. 
         [0006]    Fluid paths within the controlled environment enclosures may be made from flexible tubing materials and can therefore have significant gas permeability. Gases that naturally occur in air, such as oxygen and carbon dioxide, as well as chemical decontamination agents, are known to diffuse into these tubing materials. Accumulation of these agents in flexible tubing and subsequent delayed release can be a major contamination problem during operation. This applies in particular to products or solutions that are sensitive to exposure to alkylating agents, oxidizers, radicals or carbon dioxide. A typical example of human intervention involving the use of gloves is the installation of the fluid path or multiple fluid paths after the completion of decontamination. 
         [0007]    In view of the above there remains a need for controlled environments that do not require human intervention via the use of gloves. 
       SUMMARY OF THE INVENTION 
       [0008]    In one aspect of the invention there is provided a method for installing a fluid path within a controlled environment enclosure comprising, protecting the fluid path against an environment external to the fluid path; introducing the fluid path into the controlled environment enclosure; decontaminating the controlled environment enclosure; and mechanically unprotecting the fluid path within the controlled environment enclosure. The mechanically unprotecting can be by a robotic arm manipulation system. The decontaminating the controlled environment enclosure is automatically done after the introducing the fluid path into the controlled environment enclosure. The unprotecting is automatically done after the decontaminating the controlled environment enclosure. 
         [0009]    In one aspect of the invention there is provided a method for transferring within a controlled environment enclosure a fluid along a fluid path to a destination within the controlled environment enclosure, comprising protecting the fluid path against an environment external to the fluid path; introducing the fluid path into the controlled environment enclosure; decontaminating the controlled environment enclosure; mechanically unprotecting the fluid path within the controlled environment enclosure; and transferring the fluid to the destination along the fluid path. The mechanically unprotecting can be by a robotic arm manipulation system. The fluid path can comprise a pre-sterilized tube. The method can further comprise filtering the fluid in the fluid path and the filtering can be sterile filtering. The destination can be at least one of a culture of cells, a culture of tissue, an enzyme solution, a suspension of immobilized enzymes, a mix of active ingredients, and an excipient. The fluid can be an aseptic fluid. The controlled environment enclosure can be an isolator. The destination can be microwell plates or containers for pharmaceutical products. 
         [0010]    In one aspect of the invention there is provided a method for uninstalling a fluid path from a controlled environment enclosure, comprising mechanically protecting the fluid path within the controlled environment enclosure; decontaminating the controlled environment enclosure; opening the controlled environment enclosure; and removing the fluid path from the controlled environment enclosure. The mechanically protecting can be by a robotic arm manipulation system. The decontaminating the controlled environment enclosure can be done automatically after the protecting the fluid path. The opening the controlled environment enclosure can be done automatically after the decontaminating the controlled environment enclosure. 
         [0011]    In one aspect of the invention there is provided a method for decontaminating a controlled environment enclosure having a fluid path, the method comprising mechanically protecting by a robotic action the fluid path within the controlled environment enclosure; decontaminating the controlled environment enclosure; and opening and closing the controlled environment enclosure. The opening and closing the controlled environment enclosure can be done before or after the decontaminating the controlled environment enclosure. The mechanically protecting can be by a robotic arm manipulation system. The decontaminating the controlled environment enclosure can be done automatically after the mechanically protecting the fluid path. 
         [0012]    In one aspect of the invention there is provided an apparatus for protection and unprotection of a fluid path within a controlled environment enclosure that includes a fluid path terminated by a fill needle with removable sheath, and a remotely operated manipulation system for protection and/or unprotection of the fluid path. The remotely operated manipulation system can include a robotic arm manipulation system. The apparatus can further include a tamper-evident device positioned to reveal a breach of seal between the sheath and the fill needle. The apparatus can further include a removal station that includes a surface operative to interact with part of the sheath. The remotely operated manipulation system can include a robot end tool including at least one surface that is shaped to hold the fill needle. The fluid path can be a pre-sterilized unit. 
         [0013]    In one aspect of the invention there is provided an apparatus for installing a fluid path within a controlled environment enclosure that includes means for conveying the fluid, and remotely operated means for protecting and/or unprotecting the means for conveying the fluid. 
         [0014]    The inventors envision that compact and well-designed automated equipment can be operated inside closed controlled environments without the use of any gloves, eliminating thereby the risk of leaky gloves. The invention provides a method of installing a fluid path inside a controlled environment enclosure without the use of gloves. This requires the fluid path to be protected during the decontamination process and to be unprotected prior to the use of the fluid path. Furthermore the fluid path can be automatically closed after use. 
         [0015]    The closed fluid path can be re-opened and re-used at a later time. This can be useful for continuing the use of the fluid path after unplanned events that require breaking of the integrity of the enclosed controlled environment. Additionally the closing of the fluid path can be particularly useful in situations where the fluid path has been in use for transfer of hazardous substances. After closing of the fluid path, the enclosed environment can be cleaned and decontaminated; after which the fluid path can be removed. 
         [0016]    Other features, elements, steps, characteristics and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0017]    In the drawings, which are not necessarily drawn to scale, like numerals may describe similar components in different views. Like numerals having different letter suffixes may represent different instances of similar components. The drawings illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. 
           [0018]      FIG. 1  shows an apparatus for the protecting and unprotecting of a fluid path in a controlled environment enclosure. 
           [0019]      FIG. 2  shows detail of an end piece of an apparatus for the protecting and unprotecting of a fluid path in a controlled environment enclosure 
           [0020]      FIG. 3  shows detail of a robotic arm forming part of an apparatus for the protecting and unprotecting of a fluid path in a controlled environment enclosure 
           [0021]      FIG. 4  is a flow chart for the typical prior art method. 
           [0022]      FIG. 5  shows a method flow chart of an aspect of the invention 
           [0023]      FIG. 6  shows a method flow chart of another aspect of the invention 
           [0024]      FIG. 7  shows a method flow chart of another aspect of the invention 
           [0025]      FIG. 8  shows a method flow chart of another aspect of the invention 
       
    
    
     DETAILED DESCRIPTION 
       [0026]      FIG. 1  shows an embodiment of an apparatus for protecting and unprotecting of a fluid path  404  in a controlled environment enclosure  420 . The term “fluid” as used herein denotes any liquid, gas, liquid-gas mixtures and any mixture of solids in liquid that has fluid attributes, such as flowability or having appreciable fluidity at ambient temperature and pressure, including, without limitation, a dispersion of a solid or solids in a liquid, an emulsion, a slurry, a micro-emulsion, colloidal suspension, a suspension, a suspension of liposomes, a suspension of micelles or the like. The term “fluid path” as used herein denotes any single channel or multi channel tubing, rigid or flexible, for transporting a fluid. 
         [0027]    A fluid path  404  starts at a container  401 . The term “container” as used herein denotes any vessel suitable to hold a fluid, including without limitation any vial, syringe, ampoule, carpule, bottle, flask, beaker, bag, well in micro-well plates, well in multi-well plates, or tube. The container  401  is fitted with an air filter  402 . The container  401  can be equipped with optional sensors (not shown) to measure volume, weight of fluid, or other parameters. In some embodiments there can be multiple containers connected in parallel or in series with one another. Along the fluid path  404  there can be optional measuring devices (not shown) that measure properties, including without limitation any one or more of pressure, flow, temperature, density and conductivity. The fluid path  404  can be fitted with a filter element  403 . The filter element  403  can be selected to be suitable for sterile filtration of fluids. 
         [0028]    The fluid path  404  enters the controlled environment enclosure  420  at opening  406 . In  FIG. 1  the fluid path  404  consists of flexible tubing  405 . Opening  406  is sealed. The sealing can be, for example, via the use of a suitable flange (not shown). The container  401  and air filter  402  can be located outside the controlled environment enclosure  420 , as shown in  FIG. 1 . In other embodiments of the invention the container  401  and air filter  402  can be located inside the controlled environment enclosure  420 . 
         [0029]    Controlled environment enclosure  420  is equipped with an inlet filter  430 , an inlet valve  431 , a blower  432 , an outlet filter  433  and an outlet valve  434 . The characteristics of blower  432 , inlet filter  430  and outlet filter  433  are chosen to yield a controlled environment inside controlled environment enclosure  420 . As understood by those skilled in the art, various other filter and blower arrangements are possible to establish a controlled environment inside controlled environment enclosure  420 . A suitable controlled environment can be obtained, for example without limitation, by means of any one or more of turbulent airflow, horizontal unidirectional airflow and vertical unidirectional airflow. 
         [0030]    The fluid from container  401  can be transferred through the fluid path  404  by a number of different mechanisms, including without limitation a peristaltic pump  410  as shown in  FIG. 1 , a difference in pressure between the container  401  and the controlled environment enclosure  420 , a difference in static height of the container  401  and the end of the fluid path  404 , a gear pump, a lobe pump, a membrane pump, a piston pump, or a syringe pump. 
         [0031]    The flexible tubing  405  of the fluid path  404  can terminate with an end piece  414 . A suitable end piece can be, for example without limitation, a fill needle, a pipette dispensing system, a syringe dispensing system, a valve dispensing system, quick connectors, aseptic connectors, dispense tips and a needle for piercing of elastomers. In  FIG. 1  the end piece  414  is selected to be a fill needle. 
         [0032]    The end piece  414  can be manipulated inside the controlled environment enclosure  420  by mechanical means, for example, a robotic arm manipulation system  415 . Suitable robotic arm manipulation systems for mechanically manipulating end piece  414  include, but are not limited to, 6-axis robotic arms, Selective Compliant Articulated Robot Arm (SCARA) systems, r-theta robots, or combinations of linear actuators and rotary actuators. 
         [0033]    Fluids are transferred along the fluid path  404  to a destination, which can be containers such as the tray with vials  411  located on pedestal  412  in  FIG. 1 . The fluid path  404  may be employed for a variety of purposes including without limitation the filling of empty containers, washing and rinsing of containers, adding fluid to containers with a freeze dried powder, adding fluids to containers containing excipients and/or active ingredients, adding medium to cells, tissue or microbes, inoculating cells or microbes, adding substrate to enzyme solutions or suspensions of immobilized enzymes, adding gases such as argon or nitrogen to create an inert head space in containers, adding gases such as nitrogen, air or carbon dioxide to cells and removing fluids out of containers by suction. The term “excipient” as used herein denotes an inert substance used as a diluent or vehicle for a drug. 
         [0034]    Fluid path  404  may in some applications be required for aseptic transfer of fluids. In such a case fluid path  404  can be pre-sterilized before installation in the controlled environment enclosure  420 . The aseptic part of the fluid path  404  can start with container  401  or with filter  403 . Installation of the aseptic fluid path  404  requires sealing of the end piece  414 . 
         [0035]      FIG. 4  is a flowchart showing the prior art method for installing a fluid path in a prior art controlled environment enclosure. The prior art method requires the steps in sequence of decontaminating ( 100 ) the prior art controlled environment enclosure; transferring ( 110 ) the fluid path into the prior art controlled environment enclosure; and installing ( 120 ) by hand the fluid path in the prior art controlled environment enclosure, before using ( 130 ) the fluid path for the purpose for which it is intended. 
         [0036]    In an aspect of the invention there is provided a method for installing a fluid path  404  in the controlled environment enclosure  420 . Referring to the apparatus of  FIG. 4  and the flow chart of  FIG. 5 , the method comprises protecting ( 301 ) the fluid path  404  against an environment external to the fluid path  404 , introducing ( 302 ) the fluid path  404  into the controlled environment enclosure  420 , decontaminating ( 303 ) the controlled environment enclosure  420 , and mechanically unprotecting ( 304 ) the fluid path  404 . In its unprotected state fluid path  404  can then be used for transporting ( 305 ) fluids to destination  411 , which fluids can be aseptic or sterile fluids. Such transporting ( 305 ) of fluids can comprise filtering the fluid in the fluid path  404  using filter element  403  and the filtering can be sterile filtering. The terms “sterile” and “aseptic” are used interchangeably in this specification. The term “decontamination” as used herein denotes a process for removing or inactivating contamination, including without limitation viruses, bacteria, spores, prions, molds, yeasts, proteins, pyrogens and endotoxins, to acceptable levels. “Decontamination” as used herein includes both sterilization (that is, the destruction of all microorganisms, including bacterial spores to a probability of surviving organisms of typically less than 1:10 6 ) and disinfection (that is, the destruction and removal of specific types of micro-organisms). 
         [0037]    In  FIG. 2  a suitable arrangement for mechanically unprotecting ( 304 ) fluid path  404  is shown, comprising end piece  414  of fluid path  404  in the form of a fill needle, together with a fill needle sheath  503 . The fill needle  414  comprises fill needle tubing  501  and fill needle hub  502 . When the fluid path  404  is within controlled environment enclosure  420 , the fill needle sheath  503  can be stored in a sheath removal station  413  of the controlled environment enclosure  420  shown in  FIG. 1 . 
         [0038]    The fill needle hub  502  and the fill needle tubing  501  can be glued or welded together. In alternative embodiments the fill needle hub  502  and the fill needle tubing  501  can be made as one part out of solid material. The fill needle sheath  503  can be manufactured using materials with different thermal expansion coefficients to allow it to slide on and off the fill needle hub  502  after thermal expansion. Alternatively the needle sheath  503  can be designed to have a sliding fit on the fill needle hub  502  using porous PTFE or a steam permeable elastomeric material. 
         [0039]    Protecting ( 301 ) the fluid path  404  comprises sealingly placing the fill needle sheath  503  over the fill needle  414  such that the fill needle sheath  503  seals with the needle hub  502 . The fill needle sheath  503  and needle hub  502  can be equipped with one or multiple of tamper evident features  504  that will provide evidence of breaking the seal between needle hub  502  and fill needle sheath  503 . Possible tamper evident features  504  include but are not limited to heat shrink bands, tape seals, breakable ring, tear-off connectors and snap connect tear-off connectors. Unprotecting ( 304 ) the fluid path  404  comprises removing the fill needle sheath  503  from the fill needle  414 , thereby exposing the fill needle  414  to an environment within the controlled environment enclosure  420 . When the fill needle  414  is in use within the controlled environment enclosure  420 , the fill needle sheath  503  is stored in the sheath removal station  413 . 
         [0040]    The mechanically unprotecting ( 304 ) the fill needle  414  when it is within controlled environment enclosure  420  can comprise using a robotic arm manipulation system  415  shown in  FIG. 1 .  FIG. 3  illustrates part of the robotic arm manipulation system  415  of  FIG. 1 , wherein a forearm  601  is connected to a wrist  602 , and the wrist  602  is connected to a tool flange  603 . The end tool  604 , shown in  FIG. 3  as being fork shaped, has a partially opened bore of such diameter that the end tool  604  can slide around a narrow tubular section of needle hub  502  and the end tool  604  can move upwards to establish a precise locating fit to needle hub  502 . For unprotecting ( 304 ) the fill needle  414  the end tool  604  moves the fill needle  414  with the fill needle sheath  503  and places the fill needle  414  with the fill needle sheath  503  in sheath removal station  413 . 
         [0041]    In one embodiment of the apparatus and method, the sheath removal station  413  heats the fill needle sheath  503 , which thereby expands and releases its grip or seal to the needle hub  502 . Practitioners in the field will appreciate that there are many different ways by which the fill needle sheath  503  can be removed from the fill needle  414 . The end tool  604 , through the motion of the robotic arm manipulation system  415 , removes the fill needle  414  from the fill needle sheath  503 . The fill needle sheath  503  can remain in the sheath removal station  413  while the robotic arm manipulation system  415  moves the fill needle  414  to the destination. In one embodiment of the apparatus and method the destination shown is the tray with vials  411  located on the pedestal  412  in  FIG. 1 . 
         [0042]    The end tool  604  and the needle hub  502  can have various different other shapes allowing the use of various other closure systems such as, for example without limitation, a plug, a cap with sliding fit o-ring seal with minimal occluded surface area, a cap with membrane peel-off seal, or a twist-off cap. As understood by those skilled in the art, some closure systems will be more suitable than other closure system for use with particular sterilization methods. 
         [0043]    Materials of lesser permeability can be used in the manufacture of the flexible tubing  405 , but this is not always an option. Tubing permeability can also be reduced by adding additional layers to the tubing. Example methods for establishing such additional layers around the flexible tubing  405  include, but are not limited to, heat shrinking with non-permeable polymer such as FEP, multilayer coextrusion with non-permeable polymers, creating a diffusion barrier by polymeric coating such as poly(p-xylylene), encasing with layers of tape, and the fitting of a sleeve. 
         [0044]    In a further aspect of the invention there is provided a method for uninstalling a fluid path  404  from the controlled environment enclosure  420 . Referring to the apparatus of  FIG. 1  and the flow chart of  FIG. 6 . The method comprises mechanically protecting ( 306 ) the fluid path  404  within the controlled environment enclosure  420  once the use of fluid path  404  has been completed, decontaminating ( 303 ) the controlled environment enclosure  420 , and removing ( 307 ) the fluid path  404  from the controlled environment enclosure  420 . The mechanically protecting ( 306 ) the fill needle  414  can comprise using the robotic arm manipulation system  415  shown in  FIG. 1 . 
         [0045]    The mechanically protecting ( 306 ) the fill needle  414  within controlled environment enclosure  420  can comprise using the robotic arm manipulation system  415  of  FIG. 1 . The end tool  604  (See  FIG. 3 ) of robotic arm manipulation system  415  is used to move the fill needle  414  to and place it in the fill needle sheath  503 , which is housed in the sheath removal station  413 . The sheath removal station  413  heats the fill needle sheath  503  until the fill needle sheath  503  can slide over fill needle  414  to suitably seal to needle hub  502  after cooling, to thereby protect ( 306 ) the fill needle  414  within controlled environment enclosure  420 . The robotic arm manipulation system  415  can then further move the protected fluid path  404  as may be required. 
         [0046]    In a further aspect of the invention the mechanically unprotecting ( 304 ) and the mechanically protecting ( 306 ) the fill needle  414  using the robotic arm manipulation system  415  can be done automatically. For example, a suitable controller  440  (see  FIG. 1 ), communicating control instruction with the controlled environment enclosure  420  via a control line  450 , can be programmed to automatically unprotect ( 304 ) the fill needle  414  using the robotic arm manipulation system  415  once the decontaminating ( 303 ) the controlled environment enclosure  420  has been completed. Such automation obviates human intervention in the step of mechanically unprotecting ( 304 ) the fill needle  414 . In an embodiment of the method, the step of decontaminating ( 303 ) the controlled environment enclosure  420  can also be managed by controller  440  This allows the remainder of the steps of installing the fill needle  414 , beyond the step of introducing ( 302 ) the fluid path  404  into the controlled environment enclosure  420 , to be automated using controller  440 , including the use of the fill needle for the purpose for which it is installed, and the mechanically protecting ( 306 ) the fill needle  414  after such use. 
         [0047]    In a further aspect of the invention there is provided a method for decontaminating the controlled environment enclosure  420  having a fluid path  404 . The method comprises mechanically protecting ( 306 ) the fluid path  404  within the controlled environment enclosure by sealingly placing the fill needle sheath  503  over the fill needle  414  such that the fill needle sheath  503  seals with the needle hub  502 ; decontaminating ( 303 ) the controlled environment enclosure  420 ; and opening ( 308 ) and closing ( 309 ) the controlled environment enclosure  420 . The opening ( 308 ) and closing ( 309 ) the controlled environment enclosure  420  can either be done after the decontaminating ( 303 ) the controlled environment enclosure  420 , as may be the case when the fluid or the materials at the destination  411  are dangerous. This is shown in  FIG. 7 . Alternatively, the opening ( 308 ) and closing ( 309 ) the controlled environment enclosure  420  can either be done before the decontaminating ( 303 ) the controlled environment enclosure  420 . This is shown in  FIG. 8 , as may be the case when the external environment holds potential of contaminating the fluid or the materials at the destination  411 . The mechanically protecting ( 306 ) the fill needle  414  can comprise using the robotic arm manipulation system  415  shown in  FIG. 1 , as already described. 
         [0048]    The protecting ( 306 ) the fill needle  414  using the robotic arm manipulation system  415  can be done automatically via controller  440  (see  FIG. 14 ). Controller  440  can be programmed for automatically mechanically protecting ( 306 ) the fill needle  414  using the robotic arm manipulation system  415 , prior to opening ( 308 ) and closing ( 309 ) the controlled environment enclosure  420 . The opening ( 308 ) and closing ( 309 ) the controlled environment enclosure  420  can likewise be automated via controller  440 . 
       Additional Notes 
       [0049]    The above detailed description includes references to the accompanying drawings, which form a part of the detailed description. The drawings show, by way of illustration, specific embodiments in which the invention can be practiced. These embodiments are also referred to herein as “examples.” All publications, patents, and patent documents referred to in this document are incorporated by reference herein in their entirety, as though individually incorporated by reference. In the event of inconsistent usages between this document and those documents so incorporated by reference, the usage in the incorporated reference(s) should be considered supplementary to that of this document; for irreconcilable inconsistencies, the usage in this document controls. 
         [0050]    In this document, the terms “a” or “an” are used, as is common in patent documents, to include one or more than one, independent of any other instances or usages of “at least one” or “one or more.” In this document, the term “or” is used to refer to a nonexclusive or, such that “A or B” includes “A but not B,” “B but not A,” and “A and B,” unless otherwise indicated. In the appended claims, the terms “including” and “in which” are used as the plain-English equivalents of the respective terms “comprising” and “wherein.” Also, in the following claims, the terms “including” and “comprising” are open-ended, that is, a system, device, article, or process that includes elements in addition to those listed after such a term in a claim are still deemed to fall within the scope of that claim. Moreover, in the following claims, the terms “first,” “second,” and “third,” etc. are used merely as labels, and are not intended to impose numerical requirements on their objects. 
         [0051]    Method examples described herein can be machine or computer-implemented at least in part. Some examples can include a tangible computer-readable medium or machine-readable medium encoded with instructions operable to configure an electronic device to perform methods as described in the above examples. An implementation of such methods can include code, such as microcode, assembly language code, a higher-level language code, or the like. Such code can include computer readable instructions for performing various methods. The code can form portions of computer program products. Further, the code can be tangibly stored on one or more volatile or non-volatile computer-readable media during execution or at other times. These computer-readable media can include, but are not limited to, hard disks, removable magnetic disks, removable optical disks (e.g., compact disks and digital video disks), magnetic cassettes, memory cards or sticks, random access memories (RAM&#39;s), read only memories (ROM&#39;s), and the like. 
         [0052]    The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to comply with 37 C.F.R. §1.72(b), to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment. The scope of the invention should be determined with reference to the appended claims, along with the full scope of equivalents to which such claims are entitled.