Production line for
Medical & Pharmaceutical Refrigerator Production Line Manufacturer — Vaccine, Blood Bank & ULT
We manufacture complete production lines for vaccine, blood bank and pharmaceutical refrigerator OEMs — +2°C to −86°C scope, WHO PQS / EN 60601 spec.
Investment Range
USD 800K – 4M · 100 to 1,500 medical cabinets/shift
Who Buys This Line
Vaccine, blood bank & ULT freezer OEMs for hospital, lab & pharma buyers
Certification Ready
WHO PQS E003/E004 · ISO 13485 · GMP · CE MDR · 21 CFR Part 11 ready
In one line
Reference project: India, 2026 — 10 units/day vaccine refrigerator production line delivered for a medical device manufacturer.
Who We Supply. Medical device OEMs launching or expanding a vaccine, blood bank, pharmaceutical or ultra-low-temperature (ULT) refrigerator programme. Confirmed deliveries into India, Brazil, Egypt, France and the Middle East for country-champion medical brands and private-label OEMs supplying UN cold-chain programmes (Gavi, UNICEF). Production line volumes 10 – 200 units/day depending on cabinet type.
What we deliver. Production line equipment only — vacuum-forming and foaming moulds for medical-cabinet specs, high-pressure PU foaming machine with tightened metering tolerance (±2 % vs ±5 % standard), ground-rail assembly with per-cabinet foam-shot verification, temperature-mapping test chamber bank (9-probe stations for WHO PQS uniformity), redundant alarm-board wiring, per-cabinet traceability system tying foam batch to cabinet serial. Medical compliance certifications (EN 60601-1, WHO PQS listing, ISO 13485 device design file, FDA 21 CFR Part 1271) are obtained by your medical device brand — we deliver the equipment that lets the cabinet certify.
Cabinet spec range. Four temperature tiers: (1) +2 to +8°C pharmacy refrigerators, 200 – 600 L, foam density 40 kg/m³, wall 60 – 80 mm. (2) −20 to −30°C vaccine freezers, 200 – 500 L, 45 kg/m³, wall 100 – 120 mm + double-gasket door. (3) −40 to −50°C plasma freezers, 300 – 800 L, 48 kg/m³, wall 150 mm. (4) −70 to −86°C ULT for mRNA vaccines and biobanking, 300 – 700 L, PU-VIP composite wall ≥ 200 mm.
Certification support. Reference production lines have shipped cabinets certified to EN 60601-1 (medical electrical equipment safety), EN 60601-1-2 (EMC), WHO PQS E003 family (vaccine cold chain), FDA 21 CFR Part 1271 (HCT/P storage). ISO 13485 device design file inputs, IQ/OQ template, per-cabinet mapping report, calibration certificates provided with every unit off the line.
Deep-dive engineering references — Medical Refrigerator OEM Manufacturer in China: Buyer's Pillar, Medical Refrigerator Foaming for Vaccine Cold Chain, Medical vs Food Cold Chain Refrigerator Engineering, and Walk-in Freezer Safety: OSHA + EN 378.
Scope: we supply 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.
What You Need
26-Station Ground-Rail PU Foaming Line for Refrigerator Doors — Closed-Loop Track Layout
Closed-loop ground-rail PU foaming line dedicated to refrigerator and cabinet DOOR foaming. 26 fixture stations on a continuous steel track, 20-sec cycle, 3,000–6,000 doors per shift. 2,000 × 900 mm fixture × 200 mm closing height — sized for door panels. Cyclopentane + ATEX Zone 1, steam or oil heating.
Learn More
Cyclopentane High-Pressure PU Foaming Machine
Our flagship — purpose-built for refrigerator factories chasing A+++ energy class. Cyclopentane-ready out of the box with full ATEX Zone 1 safety package. Three sizes covering 500 to 8,000 cabinets a day.
Learn More
Mold for Upright Kitchen Refrigerator
Refrigerator mould (mold) for upright kitchen refrigerator cabinets — cast aluminium PU foaming mould for commercial 2-door / 4-door / 6-door upright stainless kitchen refrigerators. Up to 1,900 × 900 × 2,000 mm. Designed for energy-efficient deep cavities and long mould life.
Learn More
PU Raw Materials System
We make refrigerator-grade PU systems — polyol blend, MDI, blowing agent, all formulated in our own plant. k-factor down to 0.018, density customizable, tuned to your cabinet and your line.
Learn MoreCabinet models you can produce on this line
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 | Mold for Upright → |
| CFD-60D3F-K | 3-door freezing | -23 to -18 | 1395 | 1033 | 200 | DONPER / WANBAO | R290 | 1820 × 805 × 1950 | Mold for Upright → |
| CFR-40D4F (HB) | Air-cooled refrigeration · Engineering Version | -2 to 10 | 925 | 330 | 115 | DONPER / WANBAO | R290 | 1210 × 805 × 1950 | Mold for Upright → |
| CFR-60D6F (HB) | Air-cooled refrigeration · Engineering Version | -2 to 10 | 1430 | 500 | 155 | DONPER / WANBAO | R290 | 1820 × 805 × 1950 | Mold for Upright → |
| CFS-40N4HF (HB) | Dual-temp air-cooled · Engineering | 0–10 | ≤-21 | 782 | 586 | 116 | DONPER / WANBAO | R290 | 1210 × 805 × 1950 | Mold for Upright → |
| CFS-60N6HF (HB) | Dual-temp air-cooled · Engineering | 0–10 | ≤-21 | 1215 | 1015 | 156 | DONPER / WANBAO | R290 | 1820 × 805 × 1950 | Mold for Upright → |
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.)
Why This Line Works — Backed by the Real Specifications
Equipment supply only — compliance certifications obtained by the medical device brand. Our role: give your line the tightening it needs to pass WHO PQS / ISO 13485 audit.
Temperature tolerance ±0.5°C across +2 to -86°C ranges
Modified refrigerator foaming with denser cores (45–55 kg/m³ vs. 35 kg/m³ standard) for ultra-low temperature stability. Cabinet temperature uniformity ±0.5°C measured per WHO PQS E03/IN05.1 protocol — the threshold vaccine refrigerators must meet.
Redundant alarm and monitoring system tooling
Cabinet pre-tooled for dual temperature sensors, redundant power switching, audible+visual+SMS alarm modules. Door foaming includes magnetic-seal integrity tooling for opening detection. All compliance hardware mounting points pre-built into cabinet moulds, not added at assembly.
ULT freezer tooling pathway -40 to -86°C
For ultra-low-temperature freezers (-40°C blood plasma, -86°C vaccines / lab samples), foaming density jumps to 50–60 kg/m³ and cabinet wall thickness to 80–120 mm. Same line backbone as standard medical refrigerators — only foaming tooling and refrigeration plant change.
Compatible with major medical certification pathways
Cabinet design pre-aligned with ISO 13485 (medical device QMS), WHO PQS (vaccine refrigerator pre-qualification), CE-MDR (EU medical device regulation), and FDA premarket. Brand handles certification with their notified body — we provide design documentation and traceability records.
Medical cold-chain engineering
Traceability & Temperature Qualification
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.
Shared engineering reference
PU foam quality, testing and acceptance
Closed-cell ratio, density uniformity and thermal testing are documented once in our quality center.
Questions factory owners ask us
What's the typical investment for a medical refrigerator production line?
Can your line meet WHO PQS vaccine refrigerator requirements?
Do you handle ISO 13485 / CE-MDR certification?
Can you supply ULT (ultra-low -86°C) freezer tooling?
What's the typical project timeline for a medical refrigerator line?
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
Warranty & Service
On-site intervention available in every region where we have delivered projects.
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.