Merck: Pharmaceutical Cold Chain Transport Cases
Challenge
Merck needed temperature-controlled transport cases for vaccines, biologics, and clinical trial materials. Cases must: (1) maintain 2-8 C for 96+ hours, (2) be ISTA 7D + WHO PQS qualified, (3) survive air/sea/road transport globally, (4) integrate with Merck's SAP + Tracelink for DSCSA compliance, (5) be reusable 200+ cycles to support ESG goals.
Solution
KeXinMaterials provided PCM (Phase Change Material) cases with: (1) vacuum-insulated panels (VIP) + medical-grade PCM, 2-8 C for 96+ hours, (2) ISTA 7D + WHO PQS E001 qualified, (3) IP65 sealed + drop tested to ISTA 3A, (4) integrated Bluetooth temperature logger + RFID + Tracelink DSCSA, (5) PP copolymer shell, 200+ cycle rating. Custom foam for Keytruda, Gardasil 9, Vaxneuvance, clinical trial materials.
Result
1,800 cases deployed across 60 countries. 18 months zero temperature excursions. 100% DSCSA compliance. Merck standardized KeXinMaterials for all global vaccine/clinical trial cold chain. 5-year MSA extension in negotiation.
Client Testimonial
Merck's cold chain cannot tolerate temperature excursions. KeXinMaterials PCM cases maintain 2-8 C for 96+ hours across 60 countries. The Tracelink DSCSA integration ensures regulatory compliance. The 200+ cycle reusability supports our carbon neutrality goals. They're now our global standard. — Merck Global Supply Chain VP
— Merck & Co., Inc.
Project Duration
Ongoing (5-year MSA in negotiation)
Total Value
$3,400,000
Industry
Pharmaceutical / Cold Chain
Related Resources
This case study demonstrates KeXinMaterials' ability to meet the most demanding requirements for the world's most demanding customers. The same engineering rigor applies across all our 40+ case studies. For similar projects, contact us at kexin@beeaa.com for a 12h custom quote.