10 engineered models spanning cleanroom, hermetic hospital and lead-lined radiation-shielding doors – built in stainless steel 304/316 and validated under our 100,000-Cycle Durability Guarantee. We help you specify airtightness to EN 12207 Class 4, ISO 14644 cleanroom compatibility, interlock logic and lead equivalence (mmPb), then ship full technical drawings for your local team. Any size, any spec, custom engineered to your specification.
A controlled-environment door fails you in high-stakes ways: it leaks across a pressure cascade and breaks cleanroom certification, it sheds particles from ledges and recesses, an airlock lets both doors open at once, or radiation escapes at an unshielded joint. As a pure manufacturer, RAX builds the door, the operator and the controls under one roof – tested from −30°C cold storage to +50°C desert – and ships English manuals and wiring diagrams so your local team installs with confidence. Large doors start from prototype to full production runs: any size, any spec, custom engineered to your specification.
GMP suites need verified airtightness for pressure cascades, interlocked airlocks between grades, and flush, cleanable, low-particle surfaces – delivered fast with the documentation regulated projects demand.
Operating theatres, ICU and isolation rooms need hermetic sliding and swing doors with fire/smoke ratings, acoustic privacy and hygienic finishes, plus lead-lined doors for radiology, CT and angiography.
ISO-class cleanrooms demand doors that preserve certification – airtight, low particle emission and cleanable – with anti-static options and reliable interlock control for material airlocks.
Medical-device manufacturing and food aseptic lines need GMP flush stainless doors and validation support – CE documentation, material certificates, BIM and traceable batch records.
Three families – cleanroom & GMP, hermetic hospital, and lead-lined radiation shielding – manufactured in-house, validated under our 100,000-Cycle Durability Guarantee and shipped with English manuals and wiring diagrams. Any size, any spec, custom engineered to your specification.
Also: Cleanroom Sliding Door
Automatic or manual sliding cleanroom door with a smooth, ledge-free leaf and low-turbulence operation for high-traffic GMP and fab passages.
View product → AirlockAlso: Airtight Interlock Clean Room Door
Interlocked airlock door system where two doors cannot open simultaneously – maintaining the pressure cascade between rooms of different cleanroom grade per GMP practice.
View product → GMP FlushFlush stainless steel 304/316 door with concealed fixings and coved, ledge-free edges for hygienic, easy-clean GMP and washdown environments.
View product → HermeticAlso: Hermetic Door · Airtight Sliding Door
Hermetic sliding door that compresses seals on three to four sides plus a floor seal on closing – near-zero leakage for operating theatres and pressure-controlled rooms.
View product →Also: Hermetic Hinged Door · Airtight Swing Door
Airtight swing door with compression sealing and a drop/cam action that presses the leaf into its gaskets – for wards, prep rooms and isolation areas.
View product → Radiation ShieldingAlso: Radiation Shielding Door · X-Ray Door
Lead-lined steel or stainless door with lead-lined glass vision panel and lapped frame overlaps, engineered to the lead equivalence (mmPb) in your shielding report.
View product →Also: X-Ray Shielding Door
Shielded swing door for diagnostic X-ray and DR rooms, with stepped/lapped joints so no direct radiation path exists at the perimeter.
View product → Heavy DutyHeavy-duty shielded sliding door for CT, angiography (DSA) and higher-energy rooms, on a reinforced rail rated for the added lead mass.
View product →Also: Medical Door
Hygienic hospital door for wards, corridors and theatres, balancing acoustic privacy, fire/smoke rating and easy-clean, impact-resistant surfaces.
View product →Clean room, hermetic and shielding doors are specified by airtightness, cleanroom compatibility, interlock logic and – for radiology – lead equivalence. The figures below are industry-standard ranges and selection guidance; the Metaflex benchmark is shown for context. RAX’s own certified values per model are confirmed on the engineering proposal with our test data.
| Airtightness / hermetic sealing | Specified to EN 12207 / EN 1026 Class 4 (the top air-permeability class) and/or a pressure differential of ≥ 100 Pa with the door sealed on all four sides, including a drop-down or compression floor seal. (Metaflex benchmarks its Medinox/Medicare doors at EN 1026/12207 Class D(4) and ≥100 Pa.) We engineer and document the sealing class your room requires. |
|---|---|
| Cleanroom ISO class (ISO 14644-1) | The room is certified to an ISO class by airborne particle count; the door is not “rated” to a class but must preserve it – airtight, low particle emission and cleanable. Typical mapping: ISO 5 (Grade A) aseptic fill / laminar flow; ISO 7 (Grade C) pharma prep; ISO 8 (Grade D) packaging / less-critical rooms; operating theatres commonly ISO 7. See the particle-count table below. |
| Interlock / airlock logic | Two (or more) airlock doors that cannot open simultaneously – typically electronic with magnetic locks, door-position sensors, indicator lights and a controller, with failsafe behaviour (one door defaulting closed) on power loss. Standard for GMP person/material airlocks (EU GMP Annex 1), commonly with ≈10-15 Pa between adjacent rooms. We supply the interlock controller and logic to your GMP design. |
| Lead equivalence (mmPb) | Engineered to your shielding report. Typical lead equivalence by application: general diagnostic X-ray / DR ≈ 2 mmPb; CT / angiography (DSA) ≈ 3-4 mmPb; nuclear medicine / high-energy higher. (Metaflex offers optional 1-3 mm lead lining.) The leaf is lead-lined steel/stainless with lead-lined glass and a frame that overlaps by ≥ the lead thickness using stepped/lapped joints so no direct radiation path exists. |
| GMP flush / hygienic design | Flush (flat, no recesses) leaf faces, concealed/covered fixings, radiused (coved) edges, no dust-collecting ledges, cleanroom-compatible silicone glazing, and smooth powder-coated or stainless surfaces. (Metaflex specifies “completely smooth finishing” with a flush opener.) |
| Materials | Stainless steel 304/316 (pharma / washdown) · galvanized steel sheet 0.4-1.5 mm · aluminium alloy profile 6063-T5 · silicone rubber seal. Full RAL colour, PVDF coating and anodizing available. (Industry cleanroom doors also use HPL faces and honeycomb/PU cores; we confirm the build per model.) |
| Acoustic performance | Hospital hermetic doors typically target Rw ≈ 28-40 dB depending on acoustic privacy needs (theatres, wards, imaging). (Metaflex benchmarks Medicare at Rw 28→39 dB and Medinox at Rw 35 dB.) RAX acoustic data is provided per model on request. |
| Fire / smoke resistance | RAX offers fire rating EI60 / EI120 capability (certificate held per model). Smoke resistance is tested to EN 1634-3 – cold smoke (Sa) and hot smoke (S200); air leakage can also be referenced to ANSI/UL 1784. (Metaflex benchmarks Medicare EI1 at 30/60 min with Sa/S200 smoke.) |
| Operation / automation / safety | Manual or automatic with low-energy operators; radar / geomagnetic / light-curtain activation; presence sensors; manual override; battery failsafe; interlock integration via dry contacts. RAX adds anti-pinch safety edge, bottom air-bag sensor, WiFi/RS485 remote (Industry 4.0 Ready) and vision windows (clear PVC / polycarbonate). Automatic pedestrian doors are governed by EN 16005. |
| Opening sizes | Custom, non-standard sizes engineered to order – Any Size, Any Spec — Deep Customization. Hospital/cleanroom single-leaf doors commonly span W800-2,200 × H2,000-3,000 mm; double-leaf and telescopic sliding for wider theatre/ward openings. |
| Cycle life | Validated under our 100,000-Cycle Durability Guarantee in our fatigue test lab, with servo-drive manufacturing for smooth, reliable automatic operation. |
The room – not the door – is certified to an ISO class. The door must not compromise it. Limits below are the ISO 14644-1 airborne particle counts that define each class.
| ISO class | ≥0.5 µm | ≥5 µm |
|---|---|---|
| ISO 5 | 3,520 | 29 |
| ISO 6 | 35,200 | 293 |
| ISO 7 | 352,000 | 2,930 |
| ISO 8 | 3,520,000 | 29,300 |
| ISO 9 | 35,200,000 | 293,000 |
Integrity note: airtightness class, cleanroom ISO compatibility, interlock logic, lead equivalence (mmPb), acoustic Rw and fire/smoke ratings shown above are industry-standard ranges, established GMP/health-physics practice, or attributed Metaflex benchmarks – provided as selection guidance, not as published RAX certified specifications. RAX’s own model-specific test data (EN 12207/1026, EN 16005, EN 1634-3, mmPb shielding certificate) is confirmed on the engineering proposal.
Regulated facilities live and die by their documentation. These are the standards that apply to cleanroom, hermetic and radiation-shielding doors – and the basis of the test reports and certificates we supply per model.
Defines cleanroom classes ISO 1-9 by airborne particle count. The room is certified to a class; the door must preserve it by being airtight, low particle emission and cleanable.
Classifies door/window airtightness from Class 0 to Class 4 and defines the test method. Class 4 is the highest airtightness and is the basis for “hermetic” claims.
Governs operating forces, sensors and entrapment protection for automatic pedestrian doors – the safety standard for automatic hermetic and cleanroom sliders and swings.
Tests smoke resistance of doorsets: cold smoke (Sa) and hot smoke (S200). Relevant to hospital fire partitions and corridor doors.
The North American air-leakage test method for door assemblies, often referenced alongside EN 12207 for projects specifying to UL.
Requires airlocks between clean zones of different grade, with interlocked doors and a defined pressure cascade (commonly ≈10-15 Pa), plus flush, cleanable, particle-shedding-controlled surfaces.
Chinese standard for medical diagnostic X-ray radiation-protection devices and doors (医用诊断 X 射线辐射防护器具装置及用具). Relevant to lead-lined/X-ray door QC; not a CE route.
Define protective devices against diagnostic X-ray and the required lead equivalence (mmPb) by workload and use factor. RAX engineers the door’s mmPb to your shielding report.
RAX’s CE scope covers EN 13241 (industrial door) and EN 12453 (operator safety). Note: automatic pedestrian cleanroom doors fall under EN 16005 / the machinery directive; we confirm the correct CE route per door type.
From pharma GMP suites and semiconductor fabs to operating theatres and radiology – engineered for airtightness, hygiene and shielding.
Cleanroom sliding/swing, interlock and GMP flush doors maintaining pressure cascades and cleanroom class compliance for aseptic fill, prep and packaging.
Airtight, low-particle, cleanable doors that preserve ISO 14644 certification, with anti-static options and reliable interlock control for material airlocks.
Hermetic sliding and swing doors for theatres, ICU, isolation/quarantine and labs – near-zero leakage, acoustic privacy and hygienic, easy-clean finishes.
Lead-lined doors for diagnostic X-ray/DR, CT, angiography (DSA), nuclear medicine and dental imaging, engineered to the mmPb in your shielding report with lead-lined glass.
GMP flush stainless doors for medical-device manufacturing and food aseptic lines, with the validation documentation regulated production requires.
Work through these eight decisions and you will have everything our engineers need to size your door and issue a proposal with technical drawings. Send us the answers via the inquiry form or WhatsApp and we take it from there.
State the ISO 14644-1 class the room must hold (e.g. ISO 5 / 7 / 8). The door is not class-rated, but must preserve certification – airtight, low particle emission and cleanable.
For hermetic and pressure-controlled rooms, specify EN 12207 / EN 1026 Class 4 and/or a sealed differential of ≥ 100 Pa, including a drop-down or compression floor seal.
For GMP airlocks, confirm the interlock requirement (two doors never open simultaneously), failsafe behaviour on power loss, indicator lights and the target pressure cascade (≈10-15 Pa).
For radiology, provide your shielding report’s required mmPb (≈2 mmPb diagnostic/DR, ≈3-4 mmPb CT/DSA, higher for nuclear medicine). We engineer the leaf, lead-lined glass and lapped frame overlaps to match.
Specify any fire integrity requirement (EI30 / EI60 / EI120) and smoke class – cold smoke (Sa) or hot smoke (S200) per EN 1634-3 – for hospital fire partitions and corridors.
State the acoustic target (Rw ≈ 28-40 dB for theatres/wards/imaging) and the hygienic finish – GMP flush stainless 304/316, cleanable low-particle surfaces, coved edges.
Manual or automatic; radar / geomagnetic / light-curtain activation; presence sensors; manual override and battery failsafe; interlock dry contacts; vision window size. Automatic pedestrian doors comply with EN 16005.
Provide the clear opening (any size, fully engineered to your specification) and request the CE Declaration, EN 12207/1026 / EN 16005 / EN 1634-3 test reports, mmPb shielding certificate, SGS material certs, BIM, the English manual and the 100,000-cycle fatigue report.
A 11,000 m² production base in Cangzhou, Hebei – clean room doors, operators and controls made under one roof, with CNC punching/bending center, servo motor assembly line and a 100,000-cycle fatigue test lab. Founded 1999; 60+ engineers, 20+ R&D engineers; exported to 50+ countries across 5,000+ overseas projects.
Any size, any spec, any RAL colour, any door type – non-standard theatre and cleanroom openings are our specialty. Large doors from prototype to full production runs, full project flexibility from prototype to container-load.
Doors + operators + controls from one factory in stainless 304/316, validated from −30°C cold storage to +50°C desert for consistent quality and stable lead time – standard 12 days per container, fast delivery for regulated projects.
Private label: panel colour, operator matching, packaging and manual translation, NDA protected. Warranty door body 2 years, operator/motor 3 years, servo motor 5 years – with IoT smart control (Industry 4.0 Ready).
Rigorous 100,000-Cycle Fatigue Testing Protocols, Validated Stainless Steel & Aluminum Alloy Materials, and Precision Servo-Drive Manufacturing. RAX holds ISO 9001:2015 and CE (EN 13241, EN 12453) with SGS material reports and Product Liability Insurance. Cleanroom-, hermetic- and shielding-specific test reports (EN 12207/1026, EN 16005, EN 1634-3 and the mmPb shielding certificate) are engineered and documented to these standards and confirmed per model on the proposal. Each order ships with a Factory Inspection Report, FAI / pre-assembly photos, the English manual and export packing with a traceable batch number.
The room – not the door – is certified to an ISO 14644-1 class by airborne particle count. Our cleanroom doors are engineered to preserve that certification: airtight sealing, low particle emission and cleanable, flush surfaces. Typical mappings are ISO 5 (Grade A) for aseptic fill and laminar flow, ISO 7 (Grade C) for pharma prep, and ISO 8 (Grade D) for packaging and less-critical rooms; operating theatres are commonly ISO 7. Tell us your room class and we confirm cleanroom-suitability data on the proposal.
EN 12207 / EN 1026 classifies door airtightness from Class 0 to Class 4, with Class 4 the highest. A “hermetic” door uses compression seals on three to four sides plus an automatic drop or compression floor seal that presses the leaf into the seals on closing, achieving near-zero leakage – typically specified to Class 4 and/or a sealed differential of ≥ 100 Pa for pressure cascades. (Metaflex benchmarks its Medinox/Medicare doors at Class D(4) and ≥100 Pa.) We engineer and document the sealing class your room requires.
An interlocked airlock has two (or more) doors that cannot open simultaneously – electronic magnetic locks, door-position sensors, indicator lights and a controller, with failsafe behaviour (one door defaulting closed) on power loss. This maintains the pressure cascade between rooms of different cleanroom grade and is standard GMP practice (EU GMP Annex 1), commonly with ≈10-15 Pa between adjacent rooms. We supply the interlock controller and logic to your GMP design.
Lead equivalence is set by your shielding report (per IEC 61331 / NCRP 147 and, in China, YY/T 0128). As a rule of thumb, general diagnostic X-ray / DR uses ≈2 mmPb, CT / angiography (DSA) ≈3-4 mmPb, and nuclear medicine / high-energy rooms higher. (Metaflex offers optional 1-3 mm lead lining.) We engineer the lead-lined leaf, lead-lined glass vision panel and lapped frame overlaps – overlapping by ≥ the lead thickness so no direct radiation path exists – to your required mmPb, and provide the shielding certificate.
RAX offers fire rating EI60 / EI120 capability (certificate held per model), with smoke resistance to EN 1634-3 – cold smoke (Sa) and hot smoke (S200) – and air leakage that can be referenced to ANSI/UL 1784. (Metaflex benchmarks Medicare EI1 at 30/60 min with Sa/S200 smoke.) Hospital hermetic doors typically target acoustic Rw ≈ 28-40 dB depending on privacy needs (Metaflex benchmarks 28-39 dB); RAX acoustic data is provided per model on request.
RAX holds ISO 9001:2015 and CE (EN 13241 industrial door, EN 12453 operator safety), with SGS material reports and Product Liability Insurance, and can support AS/NZS 4505 and UL counterpart test data. Cleanroom-, hermetic- and shielding-specific reports – EN 12207/1026 airtightness, EN 16005 operator safety, EN 1634-3 smoke and the mmPb shielding certificate – are engineered to these standards and confirmed per model. Each order ships with a Factory Inspection Report, 100,000-cycle fatigue report, FAI / pre-assembly photos, English manual, BIM and wiring diagrams, and the CE Declaration of Conformity.
Large doors start from prototype to full production runs (custom engineered to your specification), any size, any spec, any RAL colour. Lead time: sample 7-15 days, standard container 12-20 days, custom first order 20-35 days, repeat 15-20 days – fast delivery for regulated projects. Warranty is 2 years door body, 3 years operator/motor and 5 years servo motor, with free spare parts shipped DHL/FedEx in 5-7 days. RAX is a pure manufacturer and does not install on site – we ship English manuals and wiring diagrams for your local team, FOB Tianjin/Qingdao, FCL and LCL.
Send us your cleanroom ISO class, airtightness or pressure requirement, interlock/airlock needs, lead equivalence (mmPb) for radiology, fire/smoke and acoustic targets, and opening size. Our engineers reply with a proposal and technical layout – no obligation. As a pure manufacturer we ship technical drawings + English manuals + wiring diagrams so your local team installs with confidence.
