Coaxial non-contact drive clean door with independent cleaning air gap and freeze dryer door

Abstract

The application provides a coaxial non-contact drive clean door with independent cleaning air gap and a freeze dryer door, the application retains only the door shaft bearing the load bearing function, cancels all drive mechanical parts, sets the independent cleaning air gap which can be directly wiped and disinfected between the door frame and the drive side of the door body, realizes non-dead-angle cleaning and sterilization, adopts the full-sealing non-contact magnetic field drive coaxial with the hinge shaft and protruding from the surface of the door frame to realize automatic opening and closing of the door body, cancels the exposed line through two-stage wireless power supply, cooperates with the solid compression type sealing strip, and the structure completely meets the latest GMP and FDA clean specifications, and is especially suitable for the freeze dryer complete door body system. The application can meet the clean requirements of the 2026 edition of the pharmaceutical production quality management specification (GMP) and the US Food and Drug Administration (FDA), and can solve the problems of the cleaning dead angle of the traditional clean door drive mechanism, the difficulty in meeting the latest regulation certification, and the cross contamination easily caused by manual door opening.

Description

Technical Field

[0001] This invention relates to the field of cleanroom equipment technology, and in particular to a coaxial non-contact drive cleanroom door and freeze dryer door with an independent cleaning air gap. Background Technology

[0002] In high-level controlled environments such as biopharmaceutical manufacturing, freeze dryer equipment, nuclear power control, biosafety laboratories, and semiconductors, door devices must simultaneously meet multiple core requirements of GMP (Good Manufacturing Practice), including cleanability, airtight pressure differential maintenance, dust-free structure, non-clean side maintenance, fire safety, and access control.

[0003] In industries such as pharmaceuticals and biomedicine, the cleaning and sterilization capabilities of cleanroom equipment are directly related to product quality and patient safety. Article 15 of the Appendix to the Good Manufacturing Practice for Pharmaceuticals (2010 Revision), which came into effect in February 2026, explicitly stipulates: "To reduce dust accumulation and facilitate cleaning, shelves, cabinets, equipment, etc., in clean areas must not have difficult-to-clean areas. Doors should be designed for easy cleaning." FDA 21 CFR Part 211.65(a) also requires that "the design, size, and location of equipment should facilitate proper operation and cleaning." These regulations impose mandatory requirements on the cleanability of cleanroom doors.

[0004] Meanwhile, in high-cleanliness areas such as Grade A / B, personnel are the biggest source of contamination. Manually opening doors requires personnel to touch the door with their hands, elbows, or other parts of their body, which can easily cause cross-contamination. In industry practice, even with elbow-operated or foot-operated door opening methods, the risk of contamination cannot be completely eliminated, and the operation is inconvenient. Therefore, high-cleanliness areas urgently need cleanroom doors that can achieve contactless automatic opening.

[0005] However, none of the existing cleanroom door devices can simultaneously solve the two core pain points of "dead corners for cleaning drive components" and "cross-contamination from manual door opening," and have the following drawbacks:

[0006] 1. Traditional mechanical drive doors: Power is transmitted through mechanical components such as pull rods, push rods, through shafts, gears, and chains that penetrate the clean side surface. These components create gaps that cannot be cleaned and are prone to microbial growth. Mechanical transmission has inherent defects such as wear, leakage, and short lifespan. It requires regular lubrication and is prone to grease leakage that contaminates the product.

[0007] 2. Existing magnetically coupled drive doors: Although the mechanical penetration problem has been solved, there are still seals and guides in the air gap, and the permanent magnets are prone to attracting dust, which cannot meet the requirements of Class A sterile areas; residual magnetic force still exists after power failure, making manual opening difficult.

[0008] 3. Existing linear motor driven doors: The air gap is a byproduct designed for transmission and has never been used as a core means to solve cleaning problems; the drive components extend into the air gap, disrupting the continuity of cleaning; the structure is complex and the cost is high.

[0009] 4. Existing automatic doors: Although automatic opening is achieved, the drive mechanism is still exposed in the clean area or there is mechanical penetration, which cannot solve the problem of cleaning dead corners.

[0010] It is important to note that door hinges themselves do not violate cleanliness regulations. Door hinges only bear the weight of the door; they have a simple structure, a smooth surface, and are easy to clean. The real problem with existing technology lies in all the additional mechanical transmission components added to drive the door. These components are the real cleaning dead zones and sources of contamination.

[0011] Especially for freeze dryer doors, due to their unique vacuum and high / low temperature operating conditions, the problems of traditional drive structures become more prominent:

[0012] Power supply line defects: Cables need to be run through corrugated pipes between the door frame and the main door, and between the main door and the small door. Corrugated pipes are prone to dust accumulation and are difficult to clean. With long-term use, they are prone to aging and cracking, leading to sealing failure and short circuits.

[0013] Small door structural defects: More than 90% of freeze dryer feed doors adopt a lifting structure, which relies on mechanical mechanisms such as guide rails, sliders, and chains to achieve movement. There are a large number of friction pairs, which require the addition of lubricating grease. They are prone to grease leakage and metal dust contamination. The gap between the guide rail and the slider is a sanitary dead corner that cannot be thoroughly cleaned.

[0014] Defects in the sealing structure: Almost all of them use inflatable sealing strips, which are complex and prone to aging and cracking; the inside of the inflatable groove of the sealing strip cannot be cleaned, and condensate and contaminants will accumulate after long-term use; there is a risk of being sucked into the vacuum chamber under vacuum conditions.

[0015] These shortcomings together make it difficult for traditional freeze dryer doors to pass the latest regulatory certifications, which has become a key bottleneck restricting the improvement of aseptic production levels in the pharmaceutical industry. Summary of the Invention

[0016] This invention provides a coaxial non-contact driven cleanroom door and freeze dryer door with an independent cleaning air gap. Specifically, it relates to a coaxial non-contact driven cleanroom door and freeze dryer door with an independent cleaning air gap that meets GMP / FDA mandatory cleanliness requirements. It is particularly suitable for scenarios with mandatory regulations on cleaning and sterilization, such as Grade A sterile areas in the pharmaceutical industry, biosafety laboratories, and stem cell preparation rooms, and is especially suitable for complete freeze dryer door systems.

[0017] To achieve the above objectives, the present invention adopts the following technical solution.

[0018] According to one aspect of the present invention, a coaxial non-contact driven cleanroom door with an independent cleaning air gap is provided, comprising a door frame, a door body hinged to the door frame via two sets of door hinges and rotatable about the hinge axis, and a controller. The independent cleaning air gap is formed between the driving side of the door frame and the driving side of the door body. The independent cleaning air gap is designed to meet the requirements of GMP and FDA regulations for thorough cleaning and sterilization without dead angles. It is a continuous, uninterrupted gap without any moving parts, seals, or connecting structures. Sterilization is achieved by wiping with clean cloths or cotton swabs or spraying with alcohol or disinfectant.

[0019] The drive side of the door frame is provided with a fully sealed installation chamber that is completely coaxial with the hinge axis and protrudes from the clean side surface of the door frame. The clean side surface of the fully sealed installation chamber is an integrated sealed structure with no mechanical penetration, no exposed fasteners, and no dust accumulation gaps. The non-clean side is provided with an independent maintenance port.

[0020] The fully sealed installation compartment can be installed on the clean side or the non-clean side according to the requirements of the door opening inward or outward. The upper and lower sets of door hinges only bear the entire weight of the door and do not participate in the door's drive.

[0021] The fully sealed installation chamber is equipped with a non-contact power unit, and all magnetic power components are completely enclosed inside the fully sealed installation chamber.

[0022] The door drive side is provided with a recessed part that matches the arc shape of the outer surface of the fully sealed installation compartment, and a driven force unit is fixed in the recessed part.

[0023] The independent clean air gap is formed between the clean side outer surface of the fully sealed installation chamber and the inner surface of the door recess.

[0024] The independent cleaning air gap is located inside the door sealing strip, and is independent of and does not contact the door sealing strip. When the door is closed, the air gap remains continuously open, and the inner wall of the air gap is directly cleaned and disinfected without dead angles, without affecting the airtightness and pressure difference of the door.

[0025] The non-contact power unit drives the driven force unit through electromagnetic force in a non-contact manner, thereby enabling the door to automatically open and close around the hinge axis without damaging the integrity of the independent clean air gap.

[0026] The hinge axis is arranged vertically or horizontally; when the hinge axis is arranged vertically, the door is a side-opening structure; when the hinge axis is arranged horizontally, the door is an upward-opening or downward-opening structure.

[0027] The non-contact power unit can drive the door to open and close at any angle within the range of 90° and 180° around the same hinge axis; in the power-off state, there is no residual suction, no residual resistance, and no residual torque between the non-contact power unit and the driven force unit, and the door can be pushed freely by hand with zero resistance.

[0028] Preferably, the width of the independent cleaning air gap is 2mm-15mm, and the width uniformity error is ≤±0.5mm; all inner surfaces of the independent cleaning air gap are continuous smooth surfaces with a surface roughness Ra≤0.8μm, all corners are rounded with a radius of not less than 3mm, and there are no protrusions, gaps and sharp edges, which facilitates wiping and sterilization.

[0029] Preferably, the drive side surfaces of the door frame and the door body are covered with medical-grade stainless steel plates with mirror polishing and no weld seams. They are resistant to ozone, hydrogen peroxide vapor, chlorine-containing disinfectants, and gamma radiation sterilization, and are suitable for use in Class A sterile areas.

[0030] Preferably, the outer surfaces of the non-contact power unit and the driven force unit are covered with a sealed medical-grade stainless steel shell, which is flush with the surface of the fully sealed installation compartment or the recessed part of the door, without any protrusions or depressions.

[0031] Preferably, the fully sealed installation chamber is made of medical-grade stainless steel in one piece, with a mirror-polished surface and no weld seams; the non-clean side inspection port is equipped with a quick-release sealing cover and an elastic sealing ring.

[0032] Preferably, when the hinge axis is arranged horizontally, the non-contact power unit in the fully sealed installation compartment can generate lifting torque along the rotation direction of the door, bear part or all of the lifting force of the door, and lift the door to the open position.

[0033] Preferably, the system also includes multiple sets of non-contact sensors, an identification module, an emergency door opening button, a communication module, a magnetic lock, and a wireless power supply module, all electrically connected to the controller. The multiple sets of non-contact sensors include a door-opening magnetic induction sensor, a door-closing magnetic induction sensor, and a human touch sensor, enabling position control, anti-pinch protection, automatic opening and closing, emergency zero-resistance door opening, remote linkage control, and contactless power transmission. The wireless power supply module includes a first-level wireless power supply unit and a second-level wireless power supply unit. The first-level wireless power supply unit enables wireless power supply from the door frame to the door body, and the second-level wireless power supply unit enables wireless power supply from the main door body to the secondary door body, completely eliminating exposed power lines and corrugated pipes between all moving parts.

[0034] Preferably, the non-contact power unit is a permanent magnet-free eddy current rotary drive unit, a magnetic coupling drive unit, a linear electromagnetic drive unit, or an electromagnetic array drive unit.

[0035] Preferably, the door sealing strip is a solid compression sealing strip located outside the independent clean air gap, achieving complete isolation between the clean area and the non-clean area, and preventing disinfectant leakage during disinfection.

[0036] According to another aspect of the present invention, a freeze dryer door is provided, which adopts the coaxial non-contact drive clean door structure with independent cleaning air gap as described in any one of claims 1-9;

[0037] The freeze dryer door includes a vertically opening side-opening freeze dryer main door and an upward-opening freeze dryer feed door; when it is the freeze dryer main door, the hinge axis is arranged vertically and the door body is a side-opening structure; when it is the freeze dryer feed door, the hinge axis is arranged horizontally and the door body is an upward-opening structure, which can be opened inward or outward.

[0038] The fully sealed installation compartment can be adapted to be installed on the clean or non-clean side depending on whether it is internally or externally opened, and the access port is always located in the non-clean area;

[0039] The freeze dryer door frame, freeze dryer door and freeze dryer feed door are all equipped with wireless power supply modules and magnetic locks. The freeze dryer door frame can provide the first level of wireless power to the freeze dryer door, and the freeze dryer door can provide the second level of wireless power to the freeze dryer feed door.

[0040] The door sealing strip is made of vacuum-resistant solid silicone rubber, which can withstand temperatures of -55℃ to 121℃ and pressure differences of 0Pa to 0.15MPa, meeting the vacuum operating requirements of the freeze dryer.

[0041] As can be seen from the technical solutions provided by the embodiments of the present invention above, the present invention retains the door hinge that only bears the load, completely eliminating all mechanical parts used for driving; to meet the requirements of thorough cleaning and sterilization, an independent cleaning air gap for direct wiping and disinfection is designed on the driving side of the door frame and door body; automatic door opening is achieved by using a fully sealed, non-contact magnetic field drive technology that is coaxial with the hinge axis and protrudes from the surface of the door frame. The present invention uses a two-stage wireless power supply to eliminate all exposed wiring and uses a solid compression sealing strip, fully complying with the latest GMP and FDA requirements, and is particularly suitable for complete door systems of freeze dryers.

[0042] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and will become apparent from the description or may be learned by practice of the invention. Attached Figure Description

[0043] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0044] Figure 1 This is a schematic diagram of the overall structure of a hinge-side contactless direct-drive intelligent door opening device for cleanrooms and controlled environments, provided in an embodiment of the present invention.

[0045] Figure 2 is a cross-sectional structural schematic diagram of a hinge-side contactless direct-drive intelligent door opening device for cleanrooms and controlled environments provided in an embodiment of the present invention.

[0046] Figure 3 is a partially enlarged schematic diagram of an independent cleaning air gap provided in an embodiment of the present invention;

[0047] Figure 4 is a schematic diagram of the application of a complete door system for a freeze dryer provided in an embodiment of the present invention.

[0048] The component names corresponding to the labels in the diagram are as follows: 1—Door frame; 2—Door body; 3—Fully sealed installation compartment; 4—Eddy current rotary drive unit without permanent magnets; 5—Driven force unit; 501—Conductive substrate; 502—Corrosion-resistant sealing layer; 6—Non-contact sensor; 6a—Door-opening magnetic induction sensor; 6b—Door-closing magnetic induction sensor; 6c—Human touch sensor; 7—Independent cleaning air gap; 8—Door hinge; 9—Hinge axis; 10—Controller; 11—Identification module; 12—Emergency door opening button; 13—Communication module; 14—Magnetic lock; 15—Door body sealing strip; 16—Wireless power supply module; 161—Wireless power supply transmitter; 162—Wireless power supply receiver. Detailed Implementation

[0049] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0050] Those skilled in the art will understand that, unless specifically stated otherwise, the singular forms “a,” “an,” “the,” and “the” used herein may also include the plural forms. It should be further understood that the term “comprising” as used in this specification means the presence of the stated features, integers, steps, operations, elements, and / or components, but does not exclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. It should be understood that when we say an element is “connected” or “coupled” to another element, it can be directly connected or coupled to the other element, or there may be intermediate elements. Furthermore, “connected” or “coupled” as used herein can include wireless connections or couplings. The term “and / or” as used herein includes any and all combinations of one or more of the associated listed items.

[0051] It will be understood by those skilled in the art that, unless otherwise defined, all terms used herein (including technical and scientific terms) have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. It should also be understood that terms such as those defined in general dictionaries should be understood to have the same meaning as in the context of the prior art, and should not be interpreted in an idealized or overly formal sense unless defined as herein.

[0052] To facilitate understanding of the embodiments of the present invention, the following will provide further explanation and description with reference to the accompanying drawings and several specific embodiments. These embodiments do not constitute a limitation on the embodiments of the present invention.

[0053] This invention provides a coaxial, contactless drive cleanroom door and freeze dryer door with an independent cleaning air gap that fully meets the 2026 GMP and FDA cleanroom requirements. It retains the door hinge that only bears the load, completely eliminates all non-compliant mechanical parts used for driving, and achieves contactless automatic opening. This solves two major industry pain points of traditional cleanroom doors and freeze dryer doors: the existence of uncleanable dead corners on the drive side and cross-contamination caused by manual opening. It also eliminates the inherent defects of mechanical transmission, such as wear, leakage, and short lifespan.

[0054] This invention retains the door hinges located at the top and bottom of the device, which only bear the load. The door hinges themselves have a simple structure, smooth surface, and are easy to clean, and do not violate cleanliness regulations. To meet the mandatory requirements of GMP / FDA for thorough cleaning and sterilization, all mechanical parts used to drive the door (pull rods, push rods, through shafts, bellows, lifting devices, slides, etc.) are completely eliminated. To achieve automatic door opening without compromising the integrity of the independent cleaning air gap and to avoid manual cross-contamination, a fully sealed, non-contact magnetic field drive technology that is completely coaxial with the hinge axis and protrudes from the door frame surface is adopted, completely enclosing all magnetic power components in a sealed chamber. A continuous, unpartitioned independent cleaning air gap is specially designed between the fully sealed installation chamber and the recessed part of the door. This air gap can be directly wiped with a clean cloth or cotton swab or sprayed with alcohol or disinfectant for sterilization. In short: The core invention of this invention is the independent cleaning air gap. The fully sealed non-contact drive technology coaxial with the hinge axis is the necessary means to realize the air gap and automatic door opening. This is completely opposite to the logic of the prior art that "the air gap is designed for transmission and incidentally meets the cleaning requirements".

[0055] This invention provides a coaxial non-contact driven cleanroom door with an independent cleaning air gap that meets GMP / FDA cleanroom requirements, including a door frame, a door body that is hinged to the door frame via two sets of door hinges and can rotate around the hinge axis, and a controller.

[0056] The upper and lower sets of door hinges only bear the entire weight of the door and do not participate in the door's operation;

[0057] Completely eliminate all mechanical components used to drive the door;

[0058] An independent cleaning air gap, specially designed to meet GMP / FDA regulatory requirements, is provided on the door frame and door drive side. This air gap is continuous, without any moving parts, seals, or connecting structures, and can be directly sterilized using conventional cleaning tools.

[0059] The door frame drive side is equipped with a fully sealed mounting compartment that is completely coaxial with the hinge axis and protrudes from the door frame surface, completely isolating all drive systems outside the clean area;

[0060] The door drive side is provided with a recess that matches the arc shape of the fully sealed installation compartment, and the driven force unit is installed inside the recess.

[0061] It adopts contactless magnetic field drive technology, and the power is transmitted through an independent clean air gap without damaging the cleanliness and integrity of the air gap;

[0062] All access ports are located in non-clean areas, so as not to compromise the integrity of the clean surfaces.

[0063] It adopts a two-level wireless power supply architecture, completely eliminating all exposed wiring and corrugated pipes;

[0064] Solid compression sealing strips are used instead of traditional pneumatic sealing strips.

[0065] Example 1

[0066] like Figure 1 As shown in Figure -3, a preferred embodiment of the present invention is a coaxial non-contact driven cleanroom door with an independent cleaning air gap, comprising a door frame (1), a door body (2), and a controller (10). The door body (2) is hinged to the door frame (1) via two sets of upper and lower door hinges (8), and can rotate around the hinge axis (9). The two sets of upper and lower door hinges (8) only bear the entire weight of the door body (2) and do not participate in the driving of the door body. The present invention completely eliminates all mechanical components used to drive the door body, including pull rods, push rods, through shafts, bellows, lifting devices, slides, and gear chain transmission mechanisms.

[0067] The drive side of the door frame (1) is provided with a fully sealed mounting compartment (3) that is completely coaxial with the hinge axis (9) and protrudes from the clean side surface of the door frame (1). It is made of medical-grade stainless steel in one piece with a mirror-polished surface. There are no mechanical penetrations, exposed fasteners and welds on the clean side, and a quick-release sealed access port is provided on the non-clean side. The fully sealed mounting compartment (3) can be flexibly installed on the clean side or the non-clean side depending on whether the door opens inward or outward. The access port is always located in the non-clean area and does not damage the integrity of the clean area.

[0068] The fully sealed installation chamber (3) has a fixed permanent magnet eddy current rotation drive unit (4) inside. It adopts an integrated fully sealed potting structure. The interior contains only laminated iron core and multi-phase excitation coil, without moving parts and permanent magnets. All magnetic power components are completely covered inside the fully sealed installation chamber (3). After being powered on, it generates an alternating magnetic field that rotates coaxially around the hinge axis (9).

[0069] The door body (2) has a recessed part at the corresponding position on the drive side that is adapted to the arc shape of the outer surface of the fully sealed installation chamber (3). A driven force unit (5) is fixed in the recessed part, including a conductive substrate (501) and an external corrosion-resistant sealing layer (502). The overall surface is mirror polished, which meets the high cleanliness requirements.

[0070] An independent cleaning air gap (7) is formed between the clean outer surface of the fully sealed installation chamber (3) and the inner surface of the recessed part of the door (2). This independent cleaning air gap (7) is specially designed to meet the requirements of GMP / FDA regulations for thorough cleaning and sterilization. The width is 3mm~15mm, and the width uniformity error is ≤±0.5mm. All inner surfaces are continuous smooth surfaces with a surface roughness Ra≤0.8μm. All corners are rounded with a radius of not less than 3mm. There are no protrusions, gaps, or sharp edges. It can be directly wiped with a clean cloth or cotton swab or sprayed with alcohol or disinfectant for sterilization.

[0071] The independent cleaning air gap (7) is located inside the door sealing strip (15), and is independent of and does not contact the door sealing strip (15). When the door (2) is closed, the air gap always remains open, and the inner wall of the air gap can be cleaned and disinfected without dead angles, without affecting the airtightness and pressure difference between the door and the door frame.

[0072] The permanent magnet-free eddy current rotary drive unit (4) is electrically connected to the controller (10). After being powered on, the alternating magnetic field penetrates the clean side wall of the fully sealed installation chamber (3) and generates a non-contact electromagnetic force through eddy current induction, driving the driven force unit (5) to move the door (2) around the hinge axis (9) to achieve automatic opening and closing. The entire power transmission process is carried out outside the independent clean air gap (7), without damaging the cleanliness of the air gap, and at the same time avoiding cross-contamination caused by manual door opening.

[0073] The hinge axis (9) can be arranged vertically to enable the door to open and close laterally; or it can be arranged horizontally to enable the door to open up or down. The door opening angle can be set to 90° or 180°, and the same drive structure can be adapted to various door opening forms.

[0074] When the hinge axis (9) is arranged horizontally, the permanent magnet-free eddy current rotation drive unit (4) in the fully sealed installation chamber (3) can generate a constant lifting torque along the rotation direction of the door body, bearing 90%-100% of the lifting force of the door body (2), and smoothly lifting the door body to any opening position. There is no need to configure additional gas springs, counterweights and other auxiliary balancing mechanisms, which completely eliminates the dust accumulation dead angle and maintenance needs caused by the balancing mechanism.

[0075] After the power is cut off, the magnetic field of the permanent magnet eddy current rotation drive unit (4) disappears completely, with no residual attraction, no magnetic hysteresis resistance, and no residual torque. The door (2) can be manually pushed freely with zero resistance, meeting the requirements for emergency escape.

[0076] The system is also equipped with multiple sets of non-contact sensors (6), an identity recognition module (11), an emergency door opening button (12), a communication module (13), a magnetic lock (14), and a wireless power supply module (16), all of which are electrically connected to the controller (10). The multiple sets of non-contact sensors (6) include a door opening position magnetic induction sensor (6a), a door closing position magnetic induction sensor (6b), and a human body touch induction sensor (6c), realizing position control, anti-pinch protection, automatic opening and closing, emergency door opening, remote linkage control, and contactless power supply transmission. As a further optimization scheme, this system is equipped with a full-area human body touch sensing structure. The driven force unit (5) or the fully sealed installation chamber (3) is made of medical-grade stainless steel and directly serves as the capacitive sensing electrode, and its inner side is electrically connected to the human body touch induction sensor (6c). The touch induction sensor uses an industrial-grade metal touch chip, which can detect the capacitance change generated when the human body approaches or touches the stainless steel surface when wearing rubber gloves, nitrile gloves, or other insulating protective equipment, and transmit the trigger signal to the controller (10). When the controller (10) receives a touch signal, it immediately controls the non-permanent magnet eddy current rotation drive unit (4) to cut off the power and controls the door to rebound in the opposite direction, so as to achieve full-area anti-pinch protection without blind spots.

[0077] To adapt to the deep low temperature and thermal shock conditions of the freeze dryer, the interior of the fully sealed installation chamber (3) adopts a deep low temperature and thermal shock resistant potting process and selects addition-curing low temperature silicone rubber potting compound. Its applicable temperature range is not lower than -60℃ to +200℃. It does not become brittle, crack, or delaminate under the condition of -55℃. At the same time, it has good waterproof, VHP sterilization resistance and radiation resistance properties, ensuring that the drive unit can operate stably for a long time under extreme temperature cycles.

[0078] As shown in Figure 4, another embodiment of the present invention is a freeze dryer door, employing the aforementioned cleanroom door structure, including a vertically opening side-opening freeze dryer main door and an upward-opening freeze dryer feed door. When it is the freeze dryer main door, the hinge axis is vertically arranged, and the door body has a side-opening structure; when it is the freeze dryer feed door, the hinge axis is horizontally arranged, and the door body has an upward-opening structure, which can open inwards or outwards.

[0079] The fully sealed installation compartment (3) is installed on the clean side or non-clean side according to the requirements of inward / outward opening, and the access port is always located in the non-clean area. The freeze dryer door frame, freeze dryer door and freeze dryer feed door are all equipped with wireless power supply module (16) and magnetic lock (14), and adopt a two-level wireless power supply architecture: the first-level wireless power supply transmitter module built into the freeze dryer door frame has a power of 5kW and a transmission efficiency of ≥90%, which can meet all the power supply requirements of the heating wire, electromagnetic lock, temperature sensor and drive unit inside the freeze dryer door; the second-level wireless power supply transmitter module built into the freeze dryer door has a power of 2kW and a transmission efficiency of ≥90%, which can meet all the power supply requirements of the heating wire, electromagnetic lock, sensor and drive unit inside the freeze dryer feed door. No corrugated pipes and exposed lines are required, which completely eliminates the cleaning dead corners between all moving parts.

[0080] The door sealing strip is made of vacuum-resistant solid silicone rubber, which can withstand temperatures from -55℃ to 121℃ and pressure differences from 0Pa to 0.15MPa, meeting the requirements for use under all operating conditions of the freeze dryer.

[0081] By adjusting the axial length of the stator of the permanent magnet-free eddy current rotary drive unit (4), the output torque can be flexibly adjusted to adapt to the heavier freeze dryer door and the lighter freeze dryer feed door respectively. For example, using a stator with a diameter of 200 mm and a length of 1.5 m, an output torque of about 975 N·m can be obtained, which can easily drive a freeze dryer door weighing about 3.3 tons; for ultra-heavy freeze dryer doors weighing more than 5 tons, an upper and lower dual drive unit structure can be adopted, and the total output torque can reach twice that of a single drive unit.

[0082] It should be noted that the above embodiments are merely preferred embodiments of the present invention and are not intended to limit the present invention. The core of the present invention lies in retaining the load-bearing door hinge, completely eliminating all drive mechanical components, employing an independent clean air gap structure designed to meet GMP / FDA regulatory requirements, and using a fully sealed, contactless drive coaxial with the hinge axis to achieve power transmission and automatic door opening, rather than a specific drive method. In addition to the aforementioned permanent magnet-free eddy current rotation drive unit, the contactless power unit can also be a magnetic coupling drive unit, a linear electromagnetic drive unit, an electromagnetic array drive unit, or any other device capable of achieving contactless magnetic field drive. These alternative embodiments all fall within the protection scope of the present invention.

[0083] In summary, this invention can solve GMP / FDA compliance issues: it retains the easy-to-clean load-bearing door hinges, completely eliminates all non-compliant mechanical parts used for drive, and for the first time uses "independent cleaning air gaps" as the core means to solve the cleaning problem of cleanroom doors, completely eliminating cleaning dead corners on the drive side. It fully complies with Article 15 of the 2026 GMP Appendix and the mandatory requirements of FDA 21 CFR Part 211.65, and can easily pass the most stringent regulatory certifications.

[0084] This invention can avoid cross-contamination from manual door opening: This invention achieves completely contactless automatic door opening, allowing personnel to enter and exit without touching the door, thus eliminating the risk of cross-contamination between personnel and the door at the source, and is particularly suitable for high-cleanliness areas such as Class A / B.

[0085] This invention can truly achieve cleaning without dead angles: the independent cleaning air gap is continuously connected without any parts, and when the door is closed, it can be directly wiped with a clean cloth or cotton swab or sprayed with alcohol or disinfectant for cleaning and disinfection without affecting the airtightness and pressure difference.

[0086] This invention adopts a fully sealed magnetic power design: all magnetic power components are completely enclosed inside a fully sealed installation chamber with a smooth surface without protrusions or dust accumulation gaps, making it easy to clean.

[0087] The present invention adopts a coaxial drive structure that is compact and reliable: the drive mechanism is completely coaxial with the hinge axis, protrudes from the door frame surface, and perfectly matches the recessed part of the door body, without occupying extra space, and has a compact structure and stable and reliable operation.

[0088] This invention can completely eliminate the defects of mechanical transmission: contactless drive with no mechanical friction, no wear, no leakage, no need for lubrication, service life is significantly longer than traditional mechanical transmission, and maintenance costs are extremely low.

[0089] The scope of protection of this invention is not limited to a specific driving method. Regardless of whether eddy current drive, magnetic coupling drive, linear electromagnetic drive or other future contactless magnetic field drive methods are used, as long as the structure of "retaining load-bearing door hinge + independent cleaning air gap + coaxial fully sealed contactless drive" is adopted to meet GMP / FDA requirements, it falls within the scope of protection of this invention.

[0090] This invention can comprehensively solve the pain points of the freeze dryer door industry: it completely eliminates the corrugated pipe by adopting a two-level wireless power supply architecture, replaces the traditional lifting small door with an upward hinge structure, and replaces the traditional inflatable sealing strip with a solid compression sealing strip, thus solving all cleanliness defects and reliability problems of freeze dryer doors from the root.

[0091] The safety and reliability of this invention are greatly improved: the door is reliably supported by two sets of door hinges, eliminating the safety hazards of a suspended door; after a power outage, the driving magnetic field disappears completely, and the door can be manually opened with zero resistance, meeting the requirements for emergency escape; the fully sealed structure can withstand various sterilization methods and can operate stably for a long time under extreme conditions.

[0092] Those skilled in the art will understand that the accompanying drawings are merely schematic diagrams of one embodiment, and the modules or processes shown in the drawings are not necessarily essential for implementing the present invention.

[0093] As can be seen from the above description of the embodiments, those skilled in the art can clearly understand that the present invention can be implemented by means of software plus necessary general-purpose hardware platforms. Based on this understanding, the technical solution of the present invention, or the part that contributes to the prior art, can be embodied in the form of a software product. This computer software product can be stored in a storage medium, such as ROM / RAM, magnetic disk, optical disk, etc., and includes several instructions to cause a computer device (which may be a personal computer, server, or network device, etc.) to execute the methods described in various embodiments or some parts of the embodiments of the present invention.

[0094] The various embodiments in this specification are described in a progressive manner. Similar or identical parts between embodiments can be referred to mutually. Each embodiment focuses on describing the differences from other embodiments. In particular, for apparatus or system embodiments, since they are basically similar to method embodiments, the description is relatively simple; relevant parts can be referred to the descriptions in the method embodiments. The apparatus and system embodiments described above are merely illustrative. The units described as separate components may or may not be physically separate. The components shown as units may or may not be physical units; that is, they may be located in one place or distributed across multiple network units. Some or all of the modules can be selected to achieve the purpose of this embodiment according to actual needs. Those skilled in the art can understand and implement this without creative effort.

[0095] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A coaxial contactless drive cleanroom door with an independent cleaning air gap, comprising a door frame, a door body hinged to the door frame via upper and lower sets of door hinges and rotatable about the hinge axis, and a controller, characterized in that: An independent cleaning air gap is formed between the door frame drive side and the door body drive side. The independent cleaning air gap is specially designed to meet the requirements of Good Manufacturing Practice (GMP) for pharmaceutical production and the regulations of the U.S. Food and Drug Administration (FDA) for thorough cleaning and sterilization without dead angles. It is a dedicated cleaning gap that is continuous, has no moving parts, no seals, and no connecting structures. The drive side of the door frame is provided with a fully sealed installation chamber that is completely coaxial with the hinge axis and protrudes from the clean side surface of the door frame. The clean side surface of the fully sealed installation chamber is an integrated sealed structure with no mechanical penetration, no exposed fasteners, and no dust accumulation gaps. The non-clean side is provided with an independent maintenance port. The fully sealed installation compartment can be installed on the clean side or the non-clean side according to the requirements of the door opening inward or outward. The upper and lower sets of door hinges only bear the entire weight of the door and do not participate in the door's drive. The fully sealed installation chamber is equipped with a non-contact power unit, and all magnetic power components are completely enclosed inside the fully sealed installation chamber. The door drive side is provided with a recessed part that matches the arc shape of the outer surface of the fully sealed installation compartment, and a driven force unit is fixed in the recessed part. The independent clean air gap is formed between the clean side outer surface of the fully sealed installation chamber and the inner surface of the door recess. The independent cleaning air gap is located inside the door sealing strip, and is independent of and does not contact the door sealing strip. When the door is closed, the air gap remains continuously open, and the inner wall of the air gap is directly cleaned and disinfected without dead angles, without affecting the airtightness and pressure difference of the door. The non-contact power unit drives the driven force unit through electromagnetic force in a non-contact manner, thereby enabling the door to automatically open and close around the hinge axis without damaging the integrity of the independent clean air gap. The hinge axis is arranged vertically or horizontally; when the hinge axis is arranged vertically, the door is a side-opening structure; when the hinge axis is arranged horizontally, the door is an upward-opening or downward-opening structure. The non-contact power unit can drive the door to open and close at any angle within the range of 90° and 180° around the same hinge axis; in the power-off state, there is no residual suction, no residual resistance, and no residual torque between the non-contact power unit and the driven force unit, and the door can be pushed freely by hand with zero resistance.

2. The cleanroom door according to claim 1, characterized in that, The width of the independent cleaning air gap is 2mm-15mm, and the width uniformity error is ≤±0.5mm; all inner surfaces of the independent cleaning air gap are continuous smooth surfaces with a surface roughness Ra≤0.8μm, all corners are rounded with a radius of not less than 3mm, and there are no protrusions, gaps and sharp edges, which facilitates wiping and sterilization.

3. The cleanroom door according to claim 1, characterized in that, Both the door frame and the drive side surface of the door are covered with medical-grade stainless steel plates with mirror polishing and no weld seams. They are resistant to ozone, hydrogen peroxide vapor, chlorine-containing disinfectants, and gamma radiation sterilization, and are suitable for use in Class A sterile areas.

4. The cleanroom door according to claim 1, characterized in that, The outer surfaces of both the non-contact power unit and the driven force unit are covered with a sealed medical-grade stainless steel shell. The stainless steel shell is flush with the surface of the fully sealed installation compartment or the recessed part of the door, without any protrusions or depressions.

5. The cleanroom door according to claim 1, characterized in that, The fully sealed installation chamber is made of medical-grade stainless steel in one piece, with a mirror-polished surface and no weld seams; the non-clean side inspection port uses a quick-release sealing cover and is equipped with an elastic sealing ring.

6. The cleanroom door according to claim 1, characterized in that, When the hinge axis is arranged horizontally, the non-contact power unit in the fully sealed installation compartment can generate lifting torque along the rotation direction of the door, bearing part or all of the lifting force of the door and lifting the door to the open position.

7. The cleanroom door according to claim 1, characterized in that, It also includes multiple sets of non-contact sensors, an identification module, an emergency door opening button, a communication module, a magnetic lock, and a wireless power supply module, all electrically connected to the controller. The multiple sets of non-contact sensors include a door opening position magnetic induction sensor, a door closing position magnetic induction sensor, and a human touch induction sensor, realizing position control, anti-pinch protection, automatic opening and closing, emergency zero-resistance door opening, remote linkage control, and contactless power transmission. The wireless power supply module includes a first-level wireless power supply unit and a second-level wireless power supply unit. The first-level wireless power supply unit realizes wireless power supply from the door frame to the door body, and the second-level wireless power supply unit realizes wireless power supply from the main door body to the secondary door body, completely eliminating the exposed power supply lines and corrugated pipes between all moving parts.

8. The cleanroom door according to claim 1, characterized in that, The non-contact power unit is a permanent magnet-free eddy current rotation drive unit, a magnetic coupling drive unit, a linear electromagnetic drive unit, or an electromagnetic array drive unit.

9. The cleanroom door according to claim 1, characterized in that, The door sealing strip is a solid compression sealing strip located outside the independent clean air gap, achieving complete isolation between the clean area and the non-clean area, and preventing disinfectant leakage during disinfection.

10. A freeze dryer door, characterized in that, The coaxial non-contact drive cleanroom door structure with an independent cleaning air gap as described in any one of claims 1-9 is adopted; The freeze dryer door includes a vertically opening side-opening freeze dryer main door and an upward-opening freeze dryer feed door; when it is the freeze dryer main door, the hinge axis is arranged vertically and the door body is a side-opening structure; when it is the freeze dryer feed door, the hinge axis is arranged horizontally and the door body is an upward-opening structure, which can be opened inward or outward. The fully sealed installation compartment can be adapted to be installed on the clean or non-clean side depending on whether it is internally or externally opened, and the access port is always located in the non-clean area; The freeze dryer door frame, freeze dryer door and freeze dryer feed door are all equipped with wireless power supply modules and magnetic locks. The freeze dryer door frame can provide the first level of wireless power to the freeze dryer door, and the freeze dryer door can provide the second level of wireless power to the freeze dryer feed door. The door sealing strip is made of vacuum-resistant solid silicone rubber, which can withstand temperatures of -55℃ to 121℃ and pressure differences of 0Pa to 0.15MPa, meeting the vacuum operating requirements of the freeze dryer.

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