Medical & Pharmaceutical Cases

WHO PQS / FDA / CE MDR certified cold chain and medical device transport cases. Vaccine, blood, biologic, pharmaceutical, organ transport. Validated 24-96h temperature maintenance.

Related Resources

Medical Case Index

1,000+ long-tail pages

Medical Cold Chain Case Guide

1,800-word guide

EMS / Paramedic Case Guide

960-word first-responder guide

Medical Case Specs

6 models, full dimensions

Medical Vaccine UNESCO Case Study

Real B2B deployment

Medical Cold Chain Pharma Germany

Real B2B deployment

Medical ISO 9001 Test Report

Lab test report

ROHS Compliance Test Report

Lab test report

Medical Cold Chain PCM Compatibility

PCM 5C / -20C / -70C

Compatible Equipment / Brands

Pfizer-BioNTech · Moderna · Johnson & Johnson · AstraZeneca · Sinovac · Sinopharm · GSK · Sanofi · Novartis · Roche · Merck · Eli Lilly · AbbVie · Bristol-Myers Squibb · Amgen · Gilead · Regeneron · Biogen · Vertex · Novo Nordisk

Need a custom solution?

Contact KeXinMaterials for industry-specific OEM/ODM cases. 12h quote, 30-day delivery, MOQ 50-300pcs.

Email: kexin@beeaa.com WhatsApp: +86 13590555309

Industry Details & Specifications

KeXinMaterials medical and pharmaceutical cases meet ISO 13485, FDA-cGMP, and WHO PQS (Performance, Quality and Safety) standards. We provide validated cold chain solutions for vaccines (2-8°C), mRNA therapies (-20°C ± 5°C), cell and gene therapies (-70°C ± 10°C), and clinical trial sample transport. Our cases maintain temperature integrity for 24-72+ hours across international shipping lanes.

Customer Success Stories

HCA Healthcare

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Merck Cold Chain

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Pfizer Vaccine

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Harvard Medical School

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Pharma Cold Chain Germany

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Moderna mRNA Vaccine

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Regulatory framework

Medical cold chain is regulated by: FDA 21 CFR (USA), EU MDR 2017/745 (Europe), WHO PQS E001 (global vaccine), WHO Annex 5 (cold chain), ICH Q1A (stability testing), USP <1079> (cold chain), GDP (Good Distribution Practice), ISO 13485 (medical device), PIC/S (pharmaceutical inspection). For each shipment, documentation includes: certificate of analysis, temperature log, chain of custody, customs documentation, batch tracking.

Common pain points

Top 5 medical cold chain failures: (1) temperature excursion during transit (most common, 60% of incidents), (2) PCM pack failure due to improper pre-conditioning, (3) customs delays causing shipment hold, (4) data logger battery failure, (5) case damage during handling. KeXinMaterials cases address all 5 with: validated temperature maintenance, pre-conditioned PCM packs, customs documentation support, long-life data loggers, MIL-STD-810H durability.