Решения для
Production line equipment for medical refrigerator factories
Medical refrigerators — vaccine refrigerators (+2 to +8°C), blood bank refrigerators, pharmaceutical cabinets, and ultra-low-temperature freezers (-40 to -86°C) — are built on modified versions of our standard refrigerator line, with tightened temperature tolerance and redundant alarm systems. Our scope covers the production line equipment only.
In one line
Reference project: India, 2026 — 10 units/day vaccine refrigerator production line delivered for a medical device manufacturer.
Scope: UREXCEED supplies only the production line equipment (PU foaming systems, vacuum-forming moulds, door moulds, assembly line). Medical compliance certifications (ISO 13485, WHO PQS, CE-MDR, FDA) are obtained by the medical device manufacturer — they are not part of our scope.
- Medical device manufacturers
- Biomedical equipment brands
Real pains we hear from buyers — and what we ship to solve each one
Four pains every medical-refrigerator factory founder brings us. The line we ship is built for ISO 13485 traceability.
Cabinet temperature uniformity drift ±2°C — WHO PQS audit fails on the +5°C vaccine spec
WHO PQS spec requires +2 to +8°C with ±1°C uniformity across the cabinet. Path: dual evaporator + microprocessor temperature control + foam k-factor 0.019–0.021 W/m·K + sealed gasket with calibrated compression. Field-measured uniformity: ±0.5–0.8°C across 24h cycle (well inside WHO threshold).
ISO 13485 audit requires material traceability — my current supplier can't provide PU batch records
Medical equipment needs end-to-end material traceability. We ship the line with batch tagging built in: each PU polyol/iso batch tagged at receipt, tracked through dispensing logs, recorded with cabinet serial number. ISO 13485 audit gets the batch traceability evidence pack without extra factory work.
ULT -86°C biomedical freezer needs cascade refrigeration — supplier coordination is killing my timeline
We don't supply the cascade compressor system (specialized field) but we publish a verified ULT supplier list: Embraco / GMCC / Tecumseh certified cascade systems compatible with our cabinet foaming spec. Cabinet mould + foam + door + heated-gasket: we supply. Cascade cooling: you source from our pre-vetted list. Total program coordination drops from 18 months to 14 months.
Pharmaceutical refrigerator + ULT freezer + blood bank refrigerator — one line for all 3?
Pharmaceutical refrigerator (+2 to +8°C) and ULT freezer (-40 to -86°C) share the same cabinet foaming line, but require different PU formulation + wall thickness + cascade vs single-stage compressor. We design 2 base mould platforms + shared PU foaming machine. Capex USD 1.8M–2.8M covers both ranges + blood bank variant. Single line, 3 medical product families.
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Every row below is a real cabinet SKU that customers already produce using the moulds in this line — temperature class, capacity, compressor, refrigerant and overall dimensions are field-tested. Use the matrix to match your target cabinet to the right mould configuration.
| Cabinet model | Variant | Temperature (°C) | Volume (L) | Power (W) | Weight (kg) | Compressor | Refrigerant | Size (mm) | Source mould |
|---|---|---|---|---|---|---|---|---|---|
| CFD-40D2F-K | 2-door freezing | -23 to -18 | 900 | 740 | 150 | DONPER / WANBAO | R290 | 1210 × 805 × 1950 | Пресс-форма для вертикального → |
| CFD-60D3F-K | 3-door freezing | -23 to -18 | 1395 | 1033 | 200 | DONPER / WANBAO | R290 | 1820 × 805 × 1950 | Пресс-форма для вертикального → |
| CFR-40D4F (HB) | Air-cooled refrigeration · Engineering Version | -2 to 10 | 925 | 330 | 115 | DONPER / WANBAO | R290 | 1210 × 805 × 1950 | Пресс-форма для вертикального → |
| CFR-60D6F (HB) | Air-cooled refrigeration · Engineering Version | -2 to 10 | 1430 | 500 | 155 | DONPER / WANBAO | R290 | 1820 × 805 × 1950 | Пресс-форма для вертикального → |
| CFS-40N4HF (HB) | Dual-temp air-cooled · Engineering | 0–10 | ≤-21 | 782 | 586 | 116 | DONPER / WANBAO | R290 | 1210 × 805 × 1950 | Пресс-форма для вертикального → |
| CFS-60N6HF (HB) | Dual-temp air-cooled · Engineering | 0–10 | ≤-21 | 1215 | 1015 | 156 | DONPER / WANBAO | R290 | 1820 × 805 × 1950 | Пресс-форма для вертикального → |
Source: UREXCEED catalog §07 OEM/ODM cabinet series, cross-referenced to the mould that produces each SKU. Custom cabinet sizes outside this range supported — send us your cabinet drawing for a 7-day quote.
From inquiry to first commercial unit — the 6-step delivery flow
From inquiry to first medical refrigerator off your line. ~10 months for pharmaceutical refrigerator; ~14 months for ULT freezer. Add 4–6 months for your medical device certification.
- 1
Inquiry & Medical-Segment Scoping
Week 1–2Share target capacity, medical segment (pharmaceutical / vaccine / blood bank / ULT biobank), target certification (WHO PQS, CE-MDR, FDA 510k, ISO 13485), target markets. 1-page proposal + scope boundary letter in 5 days.
- 2
Detailed Proposal & Traceability Spec
Week 2–4Engineering picks cabinet mould + cascade compressor sourcing list + PU formulation per medical segment. Material traceability + batch tagging stations specced. Scope of supply: equipment (us) vs medical device certification (you) — explicit. Quote with 20-line BOM in 14 days.
- 3
Contract & QMS-Compatible Design Freeze
Week 4–830% down. Cabinet CAD + cascade compressor mounting + batch tagging integration frozen. ISO 13485 audit evidence pack template signed off.
- 4
Mould + Batch Traceability System Build
Month 3–8Cabinet moulds: 60–90 days. PU machine + batch tagging system: 60 days. Material traceability database + dispensing logs: 30 days. Pre-shipment FAT to medical-grade spec.
- 5
Sea Freight & On-Site Installation
Month 8–104–6 × 40' containers from Shanghai/Ningbo. On-site installation 3–4 weeks. Cleanroom-grade assembly area setup if you target US/EU regulated market.
- 6
Commissioning, WHO PQS / QMS Pre-Audit & Acceptance
Month 10–11First 30 trial medical refrigerators produced + tested through WHO PQS temperature uniformity protocol + 7-day stress test. Operator training to ISO 13485 QMS. Acceptance signed when 20 consecutive units pass uniformity + traceability spec. 60% payment due here. (Medical device certification continues separately on your side after acceptance.)
Почему эта линия работает — цифры берутся из реального оборудования
Только поставка оборудования — сертификаты соответствия получает бренд медицинских изделий. Наша роль: обеспечить вашей линии доработку, необходимую для прохождения аудита WHO PQS / ISO 13485.
Допуск по температуре ±0.5°C в диапазоне от +2 до -86°C
Модифицированное вспенивание холодильника с более плотными сердечниками (45–55 kg/m³ vs. стандартных 35 kg/m³) для ультранизкотемпературной стабильности. Равномерность температуры в шкафу ±0.5°C, измеренная по протоколу WHO PQS E03/IN05.1 — пороговое требование для холодильников для вакцин.
Оснастка для резервной системы сигнализации и мониторинга
Шкаф предварительно оснащён под двойные датчики температуры, резервное переключение питания, модули звуковой + визуальной + SMS-сигнализации. Вспенивание двери включает оснастку для контроля целостности магнитного уплотнения при открывании. Все точки крепления элементов соответствия предварительно встроены в пресс-формы шкафа, а не добавляются при сборке.
Путь оснастки для морозильников ULT -40 до -86°C
Для ультранизкотемпературных морозильников (-40°C плазма крови, -86°C вакцины / лабораторные образцы) плотность пены возрастает до 50–60 kg/m³, а толщина стенок шкафа — до 80–120 мм. Та же базовая линия, что и для стандартных медицинских холодильников — меняются только оснастка для вспенивания и холодильная установка.
Совместимость с основными путями медицинской сертификации
Конструкция шкафа предварительно согласована с ISO 13485 (СМК для медицинских изделий), WHO PQS (преквалификация холодильников для вакцин), CE-MDR (регламент ЕС по медицинским изделиям) и FDA premarket. Бренд проходит сертификацию у своего уполномоченного органа — мы предоставляем конструкторскую документацию и записи прослеживаемости.
Customization Options
Medical compliance + traceability is the differentiator. 4 axes built around your medical device certification.
Temperature segment
Pharmaceutical refrigerator (+2 to +8°C WHO PQS) / blood bank (+4°C ±1°C) / ULT freezer (-40 to -86°C). Dedicated mould platform per segment.
Traceability
Batch tagging built into PU dispensing logs. Cabinet serial tracks back to polyol / iso batch + foam parameters. ISO 13485 audit-ready.
Cooling system
Standard single-stage for +2 to +8°C; cascade dual-stage for ULT. We supply cabinet — verified Embraco / GMCC / Tecumseh cascade sourcing list.
Compliance scope
We supply equipment (CE + ISO 9001). You obtain WHO PQS / CE-MDR / FDA 510k / ISO 13485 on the finished device. Pre-PQS test rig included.
Foam Quality Visualization — what closed-cell structure actually looks like
The single biggest predictor of refrigerator cabinet thermal performance is the foam cell structure. Closed-cell ratio, average cell diameter and density uniformity decide whether your cabinet holds -18°C in 35°C ambient — or fails the EU Ecodesign type-test. Here's what fine and coarse PU foam look like under a scanning electron microscope.
Industry-typical low-grade PU
- Avg cell diameter
- ~400 µm
- Closed-cell ratio
- 85–90%
- k-factor (W/m·K)
- 0.025–0.028
- Density uniformity
- ±5 kg/m³
Visible voids, broken cell walls, large irregular cells. Refrigerator cabinet pull-down test fails at 32°C+ ambient. EU Ecodesign type-test fails first submission.
Our cyclopentane PU system
- Avg cell diameter
- ~100 µm
- Closed-cell ratio
- ≥95%
- k-factor (W/m·K)
- 0.019–0.021
- Density uniformity
- ±0.5 kg/m³
Uniform fine cells, intact walls, high closed-cell ratio. Refrigerator cabinet pull-down test passes at 43°C tropical ambient. EU Ecodesign / WHO PQS / ENERGY STAR first-submission pass rate 90%+.
How we measure it: Every shipment of PU raw materials runs through pilot foaming + SEM cell-structure check at our lab. Every commissioned line gets a foam parameter card with these targets — if your operators tune to the card, the foam structure stays in this range. Sample reports available on request.
Illustration · Conceptual SEM micrographs representing typical industry coarse foam (left) vs UREXCEED cyclopentane PU foam quality target (right). Real SEM reports from your specific line available after commissioning.
Application Scenarios
Medical refrigerator end-uses split by regulated temperature segment.
- Pharmaceutical refrigerator (WHO PQS, +2 to +8°C)
- Vaccine cold chain refrigerator (regulated transport / clinic storage)
- Blood bank refrigerator (+4°C ±1°C, blood/plasma)
- Laboratory specimen refrigerator (-20°C reagent / sample)
- Biobank ULT freezer (-80 to -86°C, sample/genome bank)
- Mortuary cold storage (regulated forensic refrigeration)
Вопросы, которые задают владельцы заводов
Каков типичный объём инвестиций в производственную линию медицинских холодильников?
Может ли ваша линия соответствовать требованиям WHO PQS к холодильникам для вакцин?
Занимаетесь ли вы сертификацией ISO 13485 / CE-MDR?
Можете ли вы поставить оснастку для морозильников ULT (-86°C)?
Каков типичный график проекта по линии медицинских холодильников?
Optional Add-ons
Extend Your Production Line
Five proven add-ons our 1,800+ customers ask for after their first refrigerator factory line goes live. Discuss with our engineers which fit your spec.
Raw Material Supply
PU MDI / Polyol systems sourced direct from BASF / Covestro / Wanhua, calibrated to your foam specs and climate. Container-load discounts.
Spare Parts Package
2-year wear-parts package — seals, valves, heating elements, sensors. Pre-shipped with the line, no air-freight emergencies.
Robot Integration
ABB / KUKA 6-axis robot for de-molding, demoulding, palletizing or insertion of internal components — boost throughput +30%.
Automatic Demoulding System
Vacuum-assisted demoulding for thin-wall liners and complex geometries — eliminates worker injury, halves cycle time.
Quality Inspection System
Inline foam density, void, k-factor + dimensional QC stations. Auto-reject + traceability log — meets ISO 9001 + EU appliance regulation.
ROI · Cost Analysis
Investment Range & Payback
Indicative range based on 1,800+ delivered lines. Final pricing depends on automation level + add-ons + local labor cost. Request a quote for your spec.
Configuration note: Pharmaceutical refrigerator base: USD 1.8M–2.5M. Add ULT -86°C cascade refrigeration variant: +USD 800K–1M. ISO 13485 batch traceability + WHO PQS test rig included. Add 4–6 months for your medical device certification.
Service & Support
Гарантия и сервис
Выезд на объект возможен во всех регионах, куда мы поставляли проекты.
On-Site Installation
Our engineers fly to your factory to supervise installation, layout verification, and first-run production.
Commissioning + Tuning
Trial run + parameter tuning to your local raw material, climate, and target product spec — until throughput meets contract.
Operator Training
5-10 day on-site training for production team, QC, and maintenance — bilingual manuals + video tutorials provided.
3-Year Warranty + Spares
Core equipment 3-year warranty, electrical 2-year. Spare parts in stock with global express shipment 24h dispatch.
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Turnkey Production Lines for Refrigeration Equipment Factories
"From a Single Pump to a Turnkey Line — One Partner Through Every Tier."