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Title:
FIELD-CHANGEABLE MULTI-MODE CLEANROOMS AND LABORATORIES
Document Type and Number:
WIPO Patent Application WO/2023/146908
Kind Code:
A1
Abstract:
A building includes a building shell, a moveable interior wall, and a feature grid. The building shell includes a first divider guide and a second divider guide. The moveable interior wall is configured to couple to only one of the first divider guide or the second divider guide at a time. When the moveable interior wall is coupled to the first divider guide, a first building layout including a plurality of first building layout rooms is provided and when the moveable interior wall is coupled to the second divider guide, a second building layout including a plurality of second building layout rooms is provided. The feature grid provides a feature layout for features such that each room of the plurality of first building layout rooms and the plurality of second building layout rooms contain an appropriate subset of the features regardless of a location of the moveable interior wall.

Inventors:
SERLE JEFFREY Q (US)
KYLE KEVIN THOMAS (US)
PENNY MATTHEW (US)
Application Number:
PCT/US2023/011532
Publication Date:
August 03, 2023
Filing Date:
January 25, 2023
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
GERMFREE LABORATORIES INC (US)
International Classes:
E04H1/12; E04B2/82; F24F7/00
Foreign References:
KR102188658B12020-12-08
US7228664B22007-06-12
KR102254161B12021-05-21
Attorney, Agent or Firm:
COMBS, Sean E. (US)
Download PDF:
Claims:
CLAIMS

What is claimed is:

1. A building comprising: a building shell comprising a first divider guide and a second divider guide; a moveable interior wall that is configured to couple to only one of the first divider guide or the second divider guide at a time, wherein when the moveable interior wall is coupled to the first divider guide, a first building layout comprising a plurality of first building layout rooms is provided and when the moveable interior wall is coupled to the second divider guide, a second building layout comprising a plurality of second building layout rooms is provided; and a feature grid providing a feature layout for features such that each room of the plurality of first building layout rooms and the plurality of second building layout rooms contain an appropriate subset of the features regardless of a location of the moveable interior wall.

2. The building of claim 1, further comprising a fan filter unit.

3. The building of claim 2, wherein the feature grid includes a plurality of air intakes and a plurality of air returns coupled to the fan filter unit, wherein the appropriate subset of the features for each room of the plurality of first building layout rooms and the plurality of second building layout rooms comprises one or more air intakes or air returns coupled to the fan filter unit, one or more light fixtures, and one or more electrical outlets for equipment.

4. The building of claim 3, wherein each room of the plurality of first building layout rooms and the plurality of second building layout rooms are configurable to provide one or more of: a positive air pressure or a negative air pressure at a time; a unidirectional or a bidirectional airflow; and a predetermined minimum number of air changes per hour.

5. The building of claim 3, wherein the appropriate subset of the features for each room of the plurality of first building layout rooms and the plurality of second building layout rooms further comprises one or more of an air damper, an air louver, an air valve, and an air actuator.

6. The building of claim 5, wherein the appropriate subset of the features for each room of the plurality of first building layout rooms and the plurality of second building layout rooms further comprises one or more of: a gas decontamination port; air, gas, or vacuum piping; a particle count sensor or monitor; a contamination control sensor; a fire suppression system; and a biosecurity control sensor.

7. The building of claim 1, wherein the moveable interior wall comprises a door.

8. The building of claim 7, wherein the moveable interior wall further comprises a material ingress/egress port.

9. The building of claim 1, wherein the first divider guide and the second divider guide comprise a coved structure for hermetic sealing with the moveable interior wall.

10. The building of claim 9, wherein the coved structure of the first divider guide and the second divider guide is removeable when not in use.

11. The building of claim 1 , wherein the building shell is a mobile building shell.

12. The building of claim 1, wherein the building shell is a modular building shell.

13. The building of claim 1, wherein the feature grid supports environmental conditions that meet regulatory standards, guidelines, and compliance requirements for one or more of a biopharmaceutical cleanroom, a biocontainment area, a pharmacy cleanroom, and a hazardous drug area.

14. The building of claim 1, further comprising a second moveable interior wall that is configured to couple to only one of the first divider guide or the second divider guide at a time, and wherein when the first moveable interior wall is coupled to the first divider guide or the second divider guide and the second moveable interior wall is coupled to the other of the first divider guide or the second divider guide, a third building layout comprising a plurality of third building layout rooms is provided, wherein the feature grid provides the appropriate subset of features for each room of the plurality of third building layout rooms of the third building layout.

15. The building of claim 14, further comprising: a third divider guide; and a third moveable interior wall that is configured to couple to the third divider guide, wherein when the third moveable interior wall is coupled to the third divider guide, a fourth building layout comprising a plurality of fourth building layout rooms is provided, wherein the feature grid provides the appropriate subset of features for each room of the plurality of fourth building layout rooms of the fourth building layout.

16. The building of claim 1, further comprising an environmental controller configured to: receive an indication of a change in use or a change in building layout; and adjust one or more settings of the features of the feature grid to provide appropriate environmental conditions associated with the change in use or the change in the building layout.

17. The building of claim 16, wherein the indication of the change in use or the change in building layout is received by the controller via user input.

18. The building of claim 16, wherein the indication of the change in use or the change in building layout is received by the controller via one or more environmental sensors.

19. The building of claim 16, wherein the adjusting of the one or more settings of the features of the feature grid comprises adjusting air pressure in at least one room of the plurality of first building layout rooms or the plurality of second building layout rooms from positive pressure to negative pressure or from negative pressure to positive pressure.

20. The building of claim 16, wherein the adjusting of the one or more settings of the features of the feature grid comprises adjusting air flow in at least one room of the plurality of first building layout rooms or the plurality of second building layout rooms from unidirectional air flow to bidirectional airflow or from bidirectional airflow to unidirectional airflow.

Description:
FIELD-CHANGEABLE MULTI-MODE CLEANROOMS AND LABORATORIES

BACKGROUND

[0001] With new bacteria and viruses (including variants of existing bacteria and viruses) emerging, the need for cleanroom and laboratory space is at an all-time high. However, additional space for these cleanrooms and/or laboratories may take years to build due to the complexity of the requirements for safe and effective working conditions. Even incorporating new or additional equipment may require reconfiguration of cleanroom and/or laboratory space. Furthermore, needs for treating bacteria and viruses may change from development of vaccines (e.g., for viruses), antibacterial drugs (e.g., for treatment of bacteria), as well as development of therapeutics for diseases to mass production of those vaccines, antibacterial drugs, and therapeutics. Currently, it takes a lot of time to change a cleanroom or laboratory space for one particular type of use (e.g., vaccine development) to another type of use (e.g., mass production of a vaccine). Therefore, the ability to quickly change a layout and/or use of a laboratory or cleanroom is important to enable safe and effective working conditions for the desired type of use as well as to meet the needs for effective treatment of new bacteria and viruses.

BRIEF SUMMARY

[0002] Techniques and systems for using field-changeable multi-mode cleanrooms and laboratories are described. Advantageously, when needs for laboratory and/or cleanroom space change, using field-changeable multi-mode cleanrooms and laboratories provides the safe and effective ability to quickly change a layout and/or use of a laboratory and/or cleanroom space. This flexibility cuts significant cost over building additional and/or modifying existing laboratory and/or cleanroom space.

[0003] A building includes a building shell, a moveable interior wall, and a feature grid. The building shell includes a first divider guide and a second divider guide. The moveable interior wall is configured to couple to only one of the first divider guide or the second divider guide at a time. When the moveable interior wall is coupled to the first divider guide, a first building layout including a plurality of first building layout rooms is provided and when the moveable interior wall is coupled to the second divider guide, a second building layout including a plurality of second building layout rooms is provided. The feature grid provides a feature layout for features such that each room of the plurality of first building layout rooms and the plurality of second building layout rooms contain an appropriate subset of the features regardless of a location of the moveable interior wall.

[0004] In some cases, the building further includes a fan filter unit. In some cases, the feature grid includes a plurality of air intakes and a plurality of air returns coupled to the fan filter unit, and the appropriate subset of the features for each room of the plurality of first building layout rooms and the plurality of second building layout rooms comprises one or more air intakes or air returns coupled to the fan filter unit, one or more light fixtures, and one or more electrical outlets for equipment. In some cases, each room of the plurality of first building layout rooms and the plurality of second building layout rooms are configurable to provide one or more of: a positive air pressure or a negative air pressure at a time; a unidirectional or a bidirectional airflow; and a predetermined minimum number of air changes per hour. In some cases, the appropriate subset of the features for each room of the plurality of first building layout rooms and the plurality of second building layout rooms further comprises one or more of an air damper, an air louver, an air valve, and an air actuator. In some cases, the appropriate subset of the features for each room of the plurality of first building layout rooms and the plurality of second building layout rooms further includes one or more of: a gas decontamination port; air, gas, or vacuum piping; a particle count sensor or monitor; a contamination control sensor; a fire suppression system; and a biosecurity control sensor.

[0005] In some cases, the moveable interior wall includes a door. In some cases, the moveable interior wall further includes a material ingress/egress port. In some cases, the first divider guide and the second divider guide comprise a coved structure for hermetic sealing with the moveable interior wall. In some cases, the coved structure of the first divider guide and the second divider guide is removeable when not in use. In some cases, the building shell is a mobile building shell. In some cases, the building shell is a modular building shell. In some cases, the feature grid supports environmental conditions that meet regulatory standards, guidelines, and compliance requirements for one or more of a biopharmaceutical cleanroom, a biocontainment area, a pharmacy cleanroom, and a hazardous drug area.

[0006] In some cases, the building further includes a second moveable interior wall that is configured to couple to only one of the first divider guide or the second divider guide at a time, and when the first moveable interior wall is coupled to the first divider guide or the second divider guide and the second moveable interior wall is coupled to the other of the first divider guide or the second divider guide, a third building layout comprising a plurality of third building layout rooms is provided. The feature grid provides the appropriate subset of features for each room of the plurality of third building layout rooms of the third building layout. In some cases, the building further includes a third divider guide and a third moveable interior wall that is configured to couple to the third divider guide, and when the third moveable interior wall is coupled to the third divider guide, a fourth building layout comprising a plurality of fourth building layout rooms is provided. The feature grid provides the appropriate subset of features for each room of the plurality of fourth building layout rooms of the fourth building layout.

[0007] In some cases, the building further includes an environmental controller configured to: receive an indication of a change in use or a change in building layout and adjust one or more settings of the features of the feature grid to provide appropriate environmental conditions associated with the change in use or the change in the building layout. In some cases, the indication of the change in use or the change in building layout is received by the controller via user input. In some cases, the indication of the change in use or the change in building layout is received by the controller via one or more environmental sensors. In some cases, the adjusting of the one or more settings of the features of the feature grid includes adjusting air pressure in at least one room of the plurality of first building layout rooms or the plurality of second building layout rooms from positive pressure to negative pressure or from negative pressure to positive pressure. In some cases, the adjusting of the one or more settings of the features of the feature grid includes adjusting air flow in at least one room of the plurality of first building layout rooms or the plurality of second building layout rooms from unidirectional air flow to bidirectional airflow or from bidirectional airflow to unidirectional airflow.

[0008] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] Figure 1 illustrates field-changeable multi-mode cleanrooms or laboratories with two divider guides.

[0010] Figures 2-4 illustrate field-changeable multi-mode cleanrooms or laboratories with varying configurations of three divider guides.

[001 1 ] Figure 5 illustrates a process carried out by an environmental controller.

[ 0012] Figure 6 illustrates components of an environmental controller that may be used in certain embodiments described herein. DETAILED DESCRIPTION

[0013] Techniques and systems for using field-changeable multi-mode cleanrooms and laboratories are described. Advantageously, when needs for laboratory and/or cleanroom space change, using field-changeable multi-mode cleanrooms and laboratories provides the safe and effective ability to quickly change a layout and/or use of a laboratory and/or cleanroom space. This flexibility cuts significant cost over building additional and/or modifying existing laboratory and/or cleanroom space.

[0014] Indeed, the systems and methods described herein provide a platform to allow for reconfiguration of rooms in cleanrooms and laboratories that have critical environments that must be maintained within highly specific requirements and/or criteria (e.g., process flow, pressurization, particle counts, air changes per hour, relative humidity, biocontainment, single pass air, etc.). These reconfigurations are accomplished by a combination of moveable, relocatable, fixable, and sealable cleanroom and/or laboratory grade walls, doors, interlocking doors, material ingress/egress ports, and other fixtures that can be removed or moved to make a larger room or reconfigured to create additional rooms or to change environmental conditions within any of those rooms, as well as permanent fixtures that are laid out in a grid system such as lighting, air intakes, and air returns (e.g., a feature grid).

[0015 ] As used herein, an air return may refer to ductwork and/or a plenum that recycles air through a fan filter unit or exhausts air out of the building (e.g., which may or may not be filtered prior to leaving the building depending on the requirements for the use of that room).

[0016] For example, a change in use may require one or more rooms to change from positive pressure (e.g., a cleanroom environment with aseptic conditions for non-hazardous materials) to negative pressure (e.g., for working with materials that are potentially hazardous to personnel and/or the outside environment). This change from a positive pressure room may be accomplished via changes to air control features including, but not limited to, the speed of exhaust fans and/or fan filter units, changes to dampers, louvers, valves, and actuators, as well as building management systems (BMS) and/or engineering controls in those one or more rooms. These changes may be made manually (e.g., a person physically changes one or more of these settings), or automatically (e.g., a cleanroom and/or laboratory environmental controller receives an indication of the change in use and adjusts settings on these air control features to change the environmental conditions for those rooms; the indication of the change in use may be received via user input and/or via sensors that indicate a change in use). Therefore, one or more rooms in a layout can be changed from positive pressure to negative pressure (or any other environmental change that is required for the change in use of one or more rooms in the layout) without changing the layout of the cleanroom and/or laboratory because of the feature grid that is in place in the one or more rooms in the layout.

[0017] As another example, a change in layout (e.g., to make a room larger to accommodate additional equipment, materials, and/or personnel to add or remove rooms to the current layout for additional processes, equipment, materials, and/or personnel) may require changes to settings to maintain the environmental conditions in one or more rooms in the current layout. Because of the feature grid of the cleanroom and/or laboratory, once the physical changes to the layout are made, the environmental conditions may be rebalanced through changes to the speed of exhaust fans and/or fan filter units, changes to dampers, louvers, valves, and actuators, as well as BMS and/or engineering controls. In some cases, the change in layout may be detected by a cleanroom and/or laboratory environmental controller that detects (e.g., via sensors) the change to the layout of the cleanroom and/or laboratory and adjusts the settings to maintain the environmental conditions in one or more rooms in that layout. In some cases, a cleanroom and/or laboratory environmental controller may receive user input that the layout of the cleanroom and/or laboratory has changed and adjust settings in one or more rooms (e.g., one or more rooms having dimensions that have changed) in the new layout to maintain the environmental conditions for those one or more rooms. In some cases, the settings for one or more rooms in the new layout are adjusted manually to maintain the environmental conditions for those rooms.

[0018] As another example, a change in layout may also be accompanied by a change in use. In these cases, changes need to be made to account for the change in use and the change in layout (e.g., dimensions of the rooms in the layout). Because of the feature grid of the cleanroom and/or laboratory, once the physical changes to the layout are made, the environmental conditions may be altered for each room in the new layout through changes to the speed of exhaust fans and/or fan filter units, changes to dampers, louvers, valves, and actuators, as well as BMS and/or engineering controls. In some cases, the change in layout may be detected by a cleanroom and/or laboratory environmental controller that detects (e.g., via sensors) the change to the layout of the cleanroom and/or laboratory) and adjusts the settings to change the environmental conditions in one or more rooms in the new layout. In some cases, a cleanroom and/or laboratory environmental controller may receive user input that the layout of the cleanroom and/or laboratory has changed and adjust settings in one or more rooms (e.g., one or more rooms having dimensions that have changed and/or environmental conditions needing to be changed for the desired use) in the layout to change the environmental conditions (and, in some cases, to additionally maintain environmental conditions in one or more rooms whose dimensions have changed but the desired use remains the same, such as a room for dawning PPE before entering a highly controlled room) for those one or more rooms. In some cases, the settings for one or more rooms in the new layout are adjusted manually to change the environmental conditions (and, in some cases, to additionally maintain environmental conditions in one or more rooms whose dimensions have changed but the desired use remains the same) for those rooms.

[0019] To change a layout of a building shell, divider guides and one or more moveable interior walls are provided. With previous cleanrooms and laboratories, aside from the challenge with providing features to change the use of a room, it is not possible to easily reconfigure a layout of a cleanroom and/or laboratory because moving walls, doors, and/or other dividing elements can lead to unwanted leakage of air (e.g., that includes hazardous agents or particle contaminants) between rooms. Therefore, each divider guide provides structure for hermetic coupling to the moveable interior wall along edges of the moveable interior wall. Indeed, each divider guide includes structure on the floor, walls, and ceiling of a building shell. The structure of the divider guides along with the coupling to the moveable interior walls also allows for coving along the edges that improve biosealing (e.g., for hermetic containment and aseptic conditions) between rooms in the layout. In some cases, specialty sealing materials may be utilized in addition to structural coupling between the moveable interior wall and the divider guide to provide hermetic sealing between rooms in a layout.

[0020] For example, layouts may be optimized for material and/or personnel flow for the intended use of a laboratory and/or cleanroom. However, the optimal layout changes as processes change or scales up or down (e.g., from small batch bioprocessing for R&D to large scale biomanufacturing). The methods and systems described herein provide the ability to conduct aseptic filling, cell and gene therapy production, monoclonal antibody production, vaccine research, viral vector production, and advanced therapy medicinal products production all within the same laboratory and/or cleanroom with minimal on-site changes.

[0021 ] Furthermore, the location of lighting, power, air intakes and air returns (e.g., that are connected to one or more fan filter units), dampers, louvers, valves, and actuators in a grid allow for changes to dimensions of one or more rooms in a layout and/or adding or removing rooms from a layout while also allowing for changes and/or maintaining environmental conditions within those rooms. For example, one or more features listed above may be included in a grid (e.g., a feature grid) such that each room in each possible layout (e.g., by adding, removing and/or moving the moveable interior walls within the building shell) includes the necessary features to provide the minimum acceptable environmental conditions needed for the desired use for that room. For example, this may include redundant features (e.g., a plurality of air intakes and/or air returns) in a large room of a particular layout; and only a single feature (e.g., a single air intake and/or air return) in a small room of a different particular layout (e.g., the large room of the particular layout is divided by a moveable interior wall to create two small rooms of the different particular layout, with each of the smaller rooms having one or more air intakes and/or air returns from the large room because of the placement of the feature grid including the plurality of air intakes and/or air returns).

[0022] In some cases, the building shell may be a mobile building shell. For example, a mobile cleanroom and/or laboratory may be provided. In these cases, placement of features is even more essential due to the limited dimensions of a mobile building shell. Therefore, one or more fan filter units may be placed on the ceiling that control humidity while also providing necessary filtration for the cleanroom and/or laboratory. The design of the plenum from the fan filter unit(s) can be integrated into the shell of the building such that the plurality of air intakes and air returns is included in a feature grid, providing at least one air intake and/or air return to each room in each possible layout. Other air-related features that are included (e.g., in all building shells, but placement being especially important in a mobile building shell) include, but are not limited to low wall returns, filtered exhaust systems, filtered supply air systems, valves, dampers, and louvers. It should be understood that each room in each possible layout includes air-related features that filter air to an extent that is equal to or greater than the minimum required air filtering for the desired use of that room. The minimum required air filtering may include a minimum number of air changes per hour (e.g., with the minimum number being more or less depending upon the requirements/regulations for the use of the room in that layout and optimizing energy consumption), negative or positive pressurization of the room in that layout, single-pass or recirculated air (e.g., depending upon the requirements/regulations for the use of the room in that layout and optimizing energy consumption), and unidirectional or bidirectional airflow.

[0023] In addition to the features described above, other features that may be included in a feature grid in a building shell include connections for any services that may be required for the use of each room include, but are not limited to ports for gas decontamination, piping (e.g., for air, gas, and/or vacuum), monitors and sensors for particle counts, contamination controls and sensors, EMS, BMS, fire suppressions systems, and biosecurity controls and sensors. [0024] Using these features that are provided in a feature grid throughout the building shell, one or more rooms in each possible layout can provide environmental conditions that meet regulatory standards, guidelines, and/or compliance. For example, biopharmaceutical cleanrooms and biocontainment areas may be required to meet cGMP (e.g., Guidance for Industry Sterile Drug Products Produced by Aseptic Processing, Current Good Manufacturing Practice, FDA regulations). Additional standards may apply, including, but not limited to ISO 14644, ISO 14698, EU GMP, and/or GAMP 5. For biocontainment areas (e.g., for use of viral vectors and vaccine development), BMBL (Biosafety in Microbiological and Biomedical Laboratories, CDC and/or NIH regulations) may also apply. For pharmacy cleanrooms and hazardous drug areas (e.g., for use of sterile and hazardous drug compounding), USP 797, USP 800, and/or CAG 003 may also apply.

[0025] Figure 1 illustrates field-changeable multi-mode cleanrooms or laboratories with two divider guides. In particular, Figure 1 illustrates Configuration A, Configuration B, and Configuration C. Referring to Configurations A-C of Figure 1, a field-changeable multimode cleanroom or laboratory building 100 includes an entry room 102, an anteroom 104 (e.g., for dawning PPE and/or to provide interlocking doors between the entry room 102 and the cleanroom/laboratory room 106; note this anteroom is not present in Configuration C), a cleanroom/laboratory room 106, an exit corridor 108 (e.g., to provide a separate space from the cleanroom/laboratory room 106 to remove PPE and exit the building 100; note this exit corridor 108 is not present in Configuration B), and a mechanical room 110 (e.g., for housing certain equipment/sy stems that are necessary for cleanroom/laboratory functionality but that may not need to be immediately accessible to personnel working in the cleanroom/laboratory; note this is an especially important space for a mobile or modular cleanroom/laboratory to have and may not be immediately adjacent to the other rooms in a traditional building).

[0026] A building shell 101 of the cleanroom or laboratory building 100 includes a first divider guide 120 and a second divider guide 122. A first moveable interior wall 124 is coupled to the first divider guide 120 and a second moveable interior wall 126 is coupled to the second divider guide 122. As illustrated, by coupling the first moveable interior wall 124 to the first divider guide 120 and the second moveable interior wall 126 to the second divider guide 122, three rooms (e.g., anteroom 104, cleanroom/laboratory room 106, and exit corridor 108) are created in this layout (as opposed to a single, large room if none of the moveable interior walls or divider guides were present). In some cases, the moveable interior walls 124, 126 are interchangeable such that moveable interior wall 124 could be positioned at either the first divider guide 120 or the second divider guide 122 at a time. In other words, the moveable interior wall 124 is configured to couple to only one of the first divider guide 120 or the second divider guide 122 at a time.

[0027] A feature grid is also included in each room in this layout. The feature grid provides a feature layout for features 130 such that each room in the layout contains an appropriate subset of the features 130 regardless of a location of the moveable interior wall(s) 124, 126. In other words, the feature grid is made up of features 130 that are laid out in a grid to ensure that each room in the layout contains an appropriate subset of the features 130 for any potential purpose for that room. For example, the cleanroom/laboratory room 106 may contain more features 130 than the entry room 102 due to the intended/potential use of the cleanroom/laboratory room 106 (e.g., for sterile and hazardous drug compounding) versus an entry room 102 (e.g., for ingress/egress of potentially non-sterile persons and/or materials).

[0028] Referring to Configuration B, the field-changeable multi-mode cleanroom or laboratory building 100 includes an entry room 102, an anteroom 104, an enlarged cleanroom/laboratory room 112, and a mechanical room 110. The building shell 101 of the cleanroom or laboratory building 100 still includes a first divider guide 120 and a second divider guide 122; however, while the first moveable interior wall 124 is still coupled to the first divider guide 120, the second moveable interior wall 126 of Figure 1 A has been removed, creating the enlarged cleanroom/laboratory room 112 from the space within the cleanroom/laboratory room 106 and the exit corridor 108 illustrated in Configuration A. Therefore, utilizing the feature grid described herein, environmental conditions in the enlarged cleanroom/laboratory room 112 can be maintained or changed to meet the requirements/regulations/compliance needed for the particular use of the enlarged cleanroom/laboratory room 112. Indeed, even though the moveable interior wall 126 of Configuration A has been removed, the features 130 present throughout the building 100 remains the same, allowing for field-changeable, multi-mode use spaces in the building 100.

[0029] Referring to Configuration C, the field-changeable multi-mode cleanroom or laboratory building 100 includes an entry room 102, an enlarged cleanroom/laboratory room 114, an exit corridor 108, and a mechanical room 110. The building shell 101 of the cleanroom or laboratory building 100 still includes a first divider guide 120 and a second divider guide 122; however, while the second moveable interior wall 126 is still coupled to the second divider guide 122, the first moveable interior wall 124 of Configuration A has been removed, creating the enlarged cleanroom/laboratory room 114 from the space within the cleanroom/laboratory room 106 and the anteroom 104 illustrated in Configuration A. Therefore, utilizing the feature grid described herein, environmental conditions in the enlarged cleanroom/laboratory room 114 can be maintained or changed to meet the requirements/regulations/compliance needed for the particular use of the enlarged cleanroom/laboratory room 114. Indeed, even though the moveable interior wall 124 of Configuration A has been removed, the features 130 present throughout the building 100 remains the same, allowing for field-changeable, multi-mode use spaces in the building 100.

[0030] Referring back to Configurations A-C, in some cases, the building 100 further includes a fan filter unit. In some cases, the feature grid includes a plurality of air intakes and a plurality of air returns coupled to the fan filter unit. The features 130 present in each room in each layout (e.g., as seen in Configuration A, Configuration B, and Configuration C) may include one or more air intake and/or air return coupled to the fan filter unit. In some cases, the appropriate subset of the features 130 for each room in each layout includes one or more air intakes and/or air returns coupled to the fan filter unit, one or more light fixtures, and one or more electrical outlets for equipment. Through the use of the appropriate subset of the features 130 for each room in each layout, one or more rooms in each layout can provide one or more of a positive air pressure or a negative air pressure at a time, a unidirectional or a bidirectional airflow, and a predetermined minimum number of air changes per hour. In some cases, all of the rooms in each layout can provide one or more of a positive air pressure or a negative air pressure at a time, a unidirectional or a bidirectional airflow, and a predetermined minimum number of air changes per hour.

[0031] In some cases, the appropriate subset of the features 130 for each room in each layout further includes one or more of an air damper, an air louver, an air valve, and an air actuator. In some cases, the appropriate subset of the features 130 for each room in each layout further includes one or more of gas decontamination port, air, gas, or vacuum piping, a particle count sensor or monitor, a contamination control sensor, a fire suppression system, and a biosecurity control sensor.

[0032] In some cases, the moveable interior wall 124, 126 includes a door. In some cases, the moveable interior wall 124, 126 further includes a material ingress/egress port. In some cases, the first divider guide 120 and/or the second divider guide 122 include a coved structure for hermetic sealing with the moveable interior wall 124, 126 and the building shell 101. As used herein, a coved structure refers to a concave surface between the moveable interior wall 124, 126 and the building shell 101. In some cases, the coved structure is impermeable. In some cases, the coved structure is removable when not in use. For example, when the coved structure is not in use, it may be removed so that the coved structure is not a tripping hazard in the cleanroom/laboratory room. [0033 ] In some cases, the building shell 101 is a mobile building shell (e.g., capable of being placed on and/or integrated with a trailer on one or more axles). In some cases, the building shell 101 is a modular building shell (e.g., completed in one or more modules that can be taken apart and/or reassembled for transportation purposes).

[0034] In some cases, the feature grid supports environmental conditions (e.g., airflow direction, temperature, humidity, minimum number of air changes per hour, air pressure, etc.) that meet regulatory standards, guidelines, and compliance requirements for one or more of a biopharmaceutical cleanroom, a biocontainment area, a pharmacy cleanroom, and a hazardous drug area.

[0035] Figures 2-4 illustrate field-changeable multi-mode cleanrooms or laboratories with varying configurations of three divider guides. Referring to Figure 2, a field-changeable multi-mode cleanroom or laboratory building 200 includes an entry room 202, an anteroom 204 (e.g., for dawning PPE and/or to provide interlocking doors between the entry room 202 and the first cleanroom/laboratory room 206), a first cleanroom/laboratory room 206, a second cleanroom/laboratory room 208, an exit corridor 210 (e.g., to provide a separate space from the second cleanroom/laboratory room 208 to remove PPE and exit the building 200), and a mechanical room 212 (e.g., for housing certain equipment/sy stems that are necessary for cleanroom/laboratory functionality but that may not need to be immediately accessible to personnel working in the cleanroom/laboratory; note this is an especially important space for a mobile or modular cleanroom/laboratory to have and may not be immediately adjacent to the other rooms in a traditional building).

[0036] A building shell 201 of the cleanroom or laboratory building 200 includes a first divider guide 220, a second divider guide 222, and a third divider guide 224. A first moveable interior wall 226 is coupled to the first divider guide 220, a second moveable interior wall 228 is coupled to the second divider guide 222, and a third moveable interior wall 230 is coupled to the third divider guide 224. As illustrated, by coupling the first moveable interior wall 226 to the first divider guide 220, the second moveable interior wall 228 to the second divider guide 222, and the third moveable interior wall 230 to the third divider guide 224, four rooms (e.g., the anteroom 204, the first cleanroom/laboratory room 206, the second cleanroom/laboratory room 208, and the exit corridor 210) are created in this layout (as opposed to a single, large room if none of the moveable interior walls or divider guides were present). In some cases, the moveable interior walls 226, 228, 230 are interchangeable such that moveable interior wall 226 could be positioned at either the first divider guide 220, the second divider guide 222, or the third divider guide 224 at a time. In other words, the moveable interior wall 226 is configured to couple to only one of the first divider guide 220, the second divider guide 222, or the third divider guide 224 at a time. The second moveable interior wall 228 and the third moveable interior wall 230 may provide similar interchangeable functionality. Note that in Figure 2, all of the divider guides 220, 222, 224 are coupled to the building shell 201. Furthermore, although all of the divider guides 220, 222, 224 are illustrated as being coupled to a moveable interior wall 226, 228, 230, any of the moveable interior walls 226, 228, 230 may be removed to allow for different room layouts.

[0037] A feature grid is also included in each room in this layout. The feature grid provides a feature layout for features 240 such that each room in the layout contains an appropriate subset of the features 240 regardless of a location of the moveable interior wall(s) 226, 228, 230. In other words, the feature grid is made up of features 240 that are laid out in a grid to ensure that each room in the layout contains an appropriate subset of the features 240 for any potential purpose (e.g., a biopharmaceutical cleanroom, a biocontainment area, a pharmacy cleanroom, and a hazardous drug area) for that room. For example, the first or second cleanroom/laboratory room 206, 208 may contain more features 240 than the entry room 202 due to the intended/potential use of the first and second cleanroom laboratory 206, 208 (e.g., for sterile and hazardous drug compounding) versus an entry room 202 (e.g., for ingress/egress of potentially non-sterile persons and/or materials).

[0038] Referring to Figure 3, a field-changeable multi-mode cleanroom or laboratory building 300 includes an entry room 302, an anteroom 304 (e.g., for dawning PPE and/or to provide interlocking doors between the entry room 302 and the first cleanroom/laboratory room 306), a first cleanroom/laboratory room 306, a second cleanroom/laboratory room 308, an exit corridor 310 (e.g., to provide a separate space from the second cleanroom/laboratory room 308 to remove PPE and exit the building 300), and a mechanical room 312 (e.g., for housing certain equipment/sy stems that are necessary for cleanroom/laboratory functionality but that may not need to be immediately accessible to personnel working in the cleanroom/laboratory; note this is an especially important space for a mobile or modular cleanroom/laboratory to have and may not be immediately adjacent to the other rooms in a traditional building).

[0039] A building shell 301 of the cleanroom or laboratory building 300 includes a first divider guide 320, a second divider guide 322, and a third divider guide 324. A first moveable interior wall 326 is coupled to the first divider guide 320, a second moveable interior wall 328 is coupled to the second divider guide 322, and a third moveable interior wall 330 is coupled to the third divider guide 324. As illustrated, by coupling the first moveable interior wall 326 to the first divider guide 320, the second moveable interior wall 328 to the second divider guide 322, and the third moveable interior wall 330 to the third divider guide 324, four rooms (e.g., the anteroom 304, the first cleanroom/laboratory room 306, the second cleanroom/laboratory room 308, and the exit corridor 310) are created in this layout (as opposed to a single, large room if none of the moveable interior walls or divider guides were present). In some cases, the moveable interior walls 326, 328, 330 are interchangeable such that moveable interior wall 326 could be positioned at either the first divider guide 320, the second divider guide 322, or the third divider guide 324 at a time. In other words, the moveable interior wall 326 is configured to couple to only one of the first divider guide 320, the second divider guide 322, or the third divider guide 324 at a time. The second moveable interior wall 328 and the third moveable interior wall 330 may provide similar interchangeable functionality. Note that in Figure 3, two of the divider guides 320, 322 are coupled to the building shell 301 and one divider guide 324 is coupled to the other divider guides 320, 322, which allows for different layouts than provided with respect to Figure 2. Furthermore, although all of the divider guides 320, 322, 324 are illustrated as being coupled to a moveable interior wall 326, 328, 330, any of the moveable interior walls 326, 328, 330 may be removed to allow for different room layouts.

[0040] A feature grid is also included in each room in this layout. The feature grid provides a feature layout for features 340 such that each room in the layout contains an appropriate subset of the features 340 regardless of a location of the moveable interior wall(s) 326, 328, 330. In other words, the feature grid is made up of features 340 that are laid out in a grid to ensure that each room in the layout contains an appropriate subset of the features 340 for any potential purpose (e.g., a biopharmaceutical cleanroom, a biocontainment area, a pharmacy cleanroom, and a hazardous drug area) for that room. For example, the first or second cleanroom/laboratory room 306, 308 may contain more features 340 than the entry room 302 due to the intended/potential use of the first and second cleanroom laboratory 306, 308 (e.g., for sterile and hazardous drug compounding) versus an entry room 302 (e.g., for ingress/egress of potentially non-sterile persons and/or materials).

[0041] Referring to Figure 4, a field-changeable multi-mode cleanroom or laboratory building 400 includes an entry room 402, an anteroom 404 (e.g., for dawning PPE and/or to provide interlocking doors between the entry room 402 and the first cleanroom/laboratory room 406), a first cleanroom/laboratory room 406, a second cleanroom/laboratory room 408, an exit corridor 410 (e.g., to provide a separate space from the first and/or second cleanroom/laboratory room 406, 408 to remove PPE and exit the building 400), and a mechanical room 412 (e.g., for housing certain equipment/sy stems that are necessary for cleanroom/laboratory functionality but that may not need to be immediately accessible to personnel working in the cleanroom/laboratory; note this is an especially important space for a mobile or modular cleanroom/laboratory to have and may not be immediately adjacent to the other rooms in a traditional building).

[0042] A building shell 401 of the cleanroom or laboratory building 400 includes a first divider guide 420, a second divider guide 422, and a third divider guide 424. A first moveable interior wall 426 is coupled to the first divider guide 420, a second moveable interior wall 428 is coupled to the second divider guide 422, and a third moveable interior wall 430 is coupled to the third divider guide 424. As illustrated, by coupling the first moveable interior wall 426 to the first divider guide 420, the second moveable interior wall 428 to the second divider guide 422, and the third moveable interior wall 430 to the third divider guide 424, four rooms (e.g., the anteroom 404, the first cleanroom/laboratory room 406, the second cleanroom/laboratory room 408, and the exit corridor 410) are created in this layout (as opposed to a single, large room if none of the moveable interior walls or divider guides were present). In some cases, the moveable interior walls 426, 428, 430 are interchangeable such that moveable interior wall 426 could be positioned at either the first divider guide 420, the second divider guide 422, or the third divider guide 424 at a time. In other words, the moveable interior wall 426 is configured to couple to only one of the first divider guide 420, the second divider guide 422, or the third divider guide 424 at a time. The second moveable interior wall 428 and the third moveable interior wall 430 may provide similar interchangeable functionality. Note that in Figure 4, two of the divider guides 420, 422 are coupled to the building shell 401 and one divider guide 424 is coupled to the second divider guide 322 and a permanent wall within the building shell 401, which allows for different layouts than provided with respect to Figures 2 or 3. Furthermore, although all of the divider guides 420, 422, 424 are illustrated as being coupled to a moveable interior wall 426, 428, 430, any of the moveable interior walls 426, 428, 430 may be removed to allow for different room layouts.

[0043] A feature grid is also included in each room in this layout. The feature grid provides a feature layout for features 440 such that each room in the layout contains an appropriate subset of the features 440 regardless of a location of the moveable interior wall(s) 426, 428, 430. In other words, the feature grid is made up of features 440 that are laid out in a grid to ensure that each room in the layout contains an appropriate subset of the features 440 for any potential purpose (e.g., a biopharmaceutical cleanroom, a biocontainment area, a pharmacy cleanroom, and a hazardous drug area) for that room. For example, the first or second cleanroom/laboratory room 406, 408 may contain more features 440 than the entry room 402 due to the intended/potential use of the first and second cleanroom laboratory 406, 408 (e.g., for sterile and hazardous drug compounding) versus an entry room 402 (e.g., for ingress/egress of potentially non-sterile persons and/or materials).

[0044] As illustrated, the same building/building shell (e.g., building shell 101, 201, 301, and/or 401) can be utilized to create different building layouts when a moveable interior wall is coupled to one of the divider guides. It should be understood that one or more features (e.g., a feature grid) described above are utilized in one or more rooms illustrated in Figures 1- 4, including at least one fan filter unit and a plurality of air intakes and a plurality of air returns coupled to the at least one fan filter unit. These features, in addition to being used to meet standards/regulations/compliance, are configurable to provide at least one of negative and positive pressure at a time, unidirectional or bidirectional airflow, and a minimum number of air changes per hour. Furthermore, the types of rooms described with respect to Figures 1-4 are for exemplary purposes; other room types and/or uses for those rooms may be included in addition to or in lieu of the types of rooms described with respect to Figures 1-4. In addition, more less or less divider guides and/or moveable interior walls (e.g., including different shapes of divider guides and/or moveable interior walls) may be included in a field-changeable multimode cleanroom or laboratory building.

[0045] Figure 5 illustrates a process carried out by an environmental controller. Referring to Figure 5, a process 500 carried out by an environmental controller includes receiving (502) an indication of a change in use or a change in building layout and adjusting (504) one or more features of the feature grid to provide appropriate environmental conditions associated with the change in use or the change in the building layout. In some cases, the indication of the change in use or the change in building layout is received (502) by the controller via user input. For example, the user may input the indication via a user interface that is coupled to the environmental controller. In some cases, the indication of the change in use or the change in building layout is received (502) by the controller via one or more environmental sensors. For example of a change in building layout, a pressure sensor may be placed on a divider guide to detect a presence of a moveable interior wall. If the moveable interior wall is present and then removed (or vice versa), the pressure sensor can send the environmental controller a signal that indicates the change. For example of a change in use, a specific type of equipment that is used for a specific type of use (e.g., a pharmacy cleanroom) can utilize one or more features of the feature grid that is specific to that type of use. In other words, the one or more features of the feature grid may only be utilized and/or necessary for a specific type of use. Therefore, the environmental controller can receive an indication (e.g., via a voltage sensor, connection sensor, pressure sensor, etc.) that those one or more features of the feature grid are in use to determine that the use for that room/layout. This also allows that environmental controller to detect changes in use for the room/layout from an indication via sensors.

[0046] In some cases, the adjusting (504) of the one or more settings of the features of the feature grid includes adjusting air pressure in at least one room of the plurality of the building layout rooms for that layout from positive pressure to negative pressure or from negative pressure to positive pressure. In some cases, the adjusting (504) of the one or more settings of the features of the feature grid includes adjusting air flow in at least one room of the plurality of the building layout rooms for that layout from unidirectional airflow to bidirectional airflow or from bidirectional airflow to unidirectional airflow. In some cases, the adjusting (504) of the one or more settings of the features of the feature grid includes adjustment of other environmental conditions, including but not limited to, air filtration, gas and/or particle decontamination, fire suppression, temperature, and humidity.

[0047] As described above, the appropriate subset of the features for each room in each layout that may be adjusted (504) can include one or more of an air damper, an air louver, an air valve, and an air actuator. In some cases, the appropriate subset of the features for each room in each layout that may be adjusted (504) includes, but is not limited to, one or more of gas decontamination port, air, gas, or vacuum piping, a particle count sensor or monitor, a contamination control sensor, a fire suppression system, and a biosecurity control sensor. In some cases, the appropriate subset of the features for each room in each layout that may be adjusted (504) includes one or more air intakes and/or air returns coupled to the fan filter unit, one or more light fixtures, and one or more electrical outlets for equipment. In some cases, the adjustment (504) of the one or more features of the feature grid is carried out automatically (e.g., via a signal to that feature being adjusted from the controller). In some cases, the adjustment (504) of the one or more features of the feature grid is carried out manually (e.g., via manual adjustment that feature being adjusted after a prompt from the control through a user interface). In some cases, the adjustment of the more features of the feature grid is carried out both automatically and manually (e.g., some features are adjusted automatically and some features are adjusted manually).

[0048] Figure 6 illustrates components of an environmental controller that may be used in certain embodiments described herein. Referring to Figure 6, an environmental controller 600 includes a processing system 610, a storage system 620, and a network/ communications interface 630. Software 625 is stored at the storage system 620, that when executed by the processing system 610, implements functionality (e.g., process 500) of the feature grid described herein. Software 625 and/or hardware components may be utilized to implement functionality of the feature grid described herein. For example, a cleanroom and/or laboratory environmental controller may be utilized to maintain (e.g., when a layout is changed) or change (e.g., when the type of use of a room is changed) environmental conditions for the desired use of each room in a layout to meet requirements/regulations/compliance. For example, the cleanroom and/or laboratory environmental controller may change physical settings of features described herein.

[0049] The cleanroom and/or laboratory environmental controller 600 may be implemented within a single computing device or distributed across multiple computing devices or sub-systems that cooperate in executing program instructions. The cleanroom and/or laboratory environmental controller 600 can include one or more microdevices (e.g., system-on-a-chip), microcontrollers such as Raspberry Pi, blade server devices, standalone server devices, personal computers, mobile devices, routers, hubs, switches, bridges, firewall devices, intrusion detection devices, mainframe computers, network-attached storage devices, and other types of computing devices.

[0050] The processing system 610 of the cleanroom and/or laboratory environmental controller 600 can include one or more processors (e.g., CPU, GPU) and/or other circuitry that retrieves and executes software from a storage system. The processing system 610 may be implemented within a single processing device but may also be distributed across multiple processing devices or sub-systems that cooperate in executing program instructions.

[0051 ] The storage system(s) 620 can include any computer readable storage media readable by the processing system and capable of storing software 625. The storage system 620 may be implemented as a single storage device but may also be implemented across multiple storage devices or sub-systems co-located or distributed relative to each other. The storage system 620 can include removable and/or non-removable memory /storage media.

[0052 ] The network/communications interface 630 provides one or more interfaces for input from and output to the “outside” world. The one or more interfaces can include network interfaces and/or user interfaces (e.g., display, keyboard, microphone, speaker, etc.). A user interface can receive user input, including indications of a change in use or a change in building layout and/or display current environmental conditions in one or more rooms of a layout. In some cases, the user interface enables a graphical user interface. A network interface can provide a connection (wired or wireless) with other devices over a network (e.g., local, wide, Internet, etc.), for example, one or more mobile devices (e.g., that have permission(s) to connect the cleanroom and/or laboratory environmental controller 600) for receiving user input.

[0053] In some cases, the network/communications interface 630 may provide a connection with one or more off-site storage resource(s) 640 and/or server(s) 650. These offsite storage resource(s) 640 and/or server(s) 650 may provide instructions and/or software 655 to the cleanroom and/or laboratory environmental controller 600 for implementing the appropriate environmental conditions for each room in each building layout (e.g., via changes to one or more features of the feature grid).

[0054] Software 625 or 655, including routines for performing computer implemented processes described above, may be implemented in program instructions and among other functions may, when executed by the cleanroom and/or laboratory environmental controller 600 in general or processing system 610 in particular, direct the cleanroom and/or laboratory environmental controller 600 or processing system 610 to operate as described herein.

[0055] Alternatively, or in addition, the functionality, methods and processes described herein can be implemented, at least in part, by one or more hardware modules (or logic components). For example, the hardware modules can include, but are not limited to, application-specific integrated circuit (ASIC) chips, field programmable gate arrays (FPGAs), system-on-a-chip (SoC) systems, complex programmable logic devices (CPLDs) and other programmable logic devices now known or later developed. When the hardware modules are activated, the hardware modules perform the functionality, methods and processes included within the hardware modules.

[0056] Embodiments may be implemented as a computer process, a computing system, or as an article of manufacture, such as a computer program product or computer-readable medium. Certain methods and processes described herein can be embodied as software, code and/or data, which may be stored on one or more storage media. Certain embodiments of the invention contemplate the use of a machine in the form of a computer system within which a set of instructions, when executed, can cause the system to perform any one or more of the methodologies discussed above (e.g., including changes to features of the feature grid). Certain computer program products may be one or more computer-readable storage media readable by a computer system (and executable by a processing system) and encoding a computer program of instructions for executing a computer process. It should be understood that as used herein, in no case do the terms “storage media”, “computer-readable storage media” or “computer- readable storage medium” consist of transitory carrier waves or propagating signals. Instead, “storage” media refers to non-transitory media. [0057 ] Although the subj ect matter has been described in language specific to structural features and/or acts, it is to be understood that the subject matter defined in the appended claims is not necessarily limited to the specific features or acts described above. Rather, the specific features and acts described above are disclosed as examples of implementing the claims and other equivalent features and acts that would be recognized by one skilled in the art are intended to be within the scope of the claims.