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Geschrieben von Dorothy
Senior Sales Manager, Doaho Test (DHT®)
I. Background
The leading European innovator specializes in the RandD and production of oncology drugs and biologics. As its pipeline drugs advance into global multi-center clinical trials, the company must adhere to ICH Q1A(R2) and cGMP requirements for long-term drug stability testing (under conditions such as 25°C/60% RH and 30°C/75% RH).
To comply with stringent EU and FDA standards for data integrity and environmental control precision, the company partnered with Doaho Test (DHT(®)) to deploy the 190L Temperature and Humidity Test Chamber.
II. Customer Needs & Challenges
1.High-Precision Environmental Control: Humidity fluctuations ≤±2% RH, temperature uniformity ≤±0.5°C to prevent drug degradation inaccuracies.
2.High-Throughput Testing: Capacity for 2,000+ vials (e.g., serum bottles, pre-filled syringes) and multi-condition parallel testing.
3.Global Collaboration: Real-time remote monitoring to support cross-border team coordination and audit readiness.
III. Solution
Doaho Test (DHT(®)) delivered a tailored solution to meet the compliance and efficiency goals:
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Ultra-Precision Climate Control: Delivering ±0.5% RH humidity accuracy and ±0.5°C temperature uniformity (unloaded).
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Modular Multi-Layer Configuration: 6 adjustable shelf layers compatible with diverse pharmaceutical packaging formats, boosting single-run testing capacity by 80%.
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Global IoT Connectivity: Systems enables real-time data synchronization across EU, US, and Asian laboratories.
VI. About Doaho Test (DHT(®))
Doaho Test (DHT(®)), specializing in environmental testing equipment R&D for 15 years, offers a comprehensive portfolio including temperature humidity test cabinet for automotive，high and low temperature chamber automotive，aging test chamber for electronics，fast ramp rate thermal chamber and so on.
Serving critical industries such as military, aerospace, meteorology, and renewable energy, we empower clients with precision, reliability, and intelligent solutions, having delivered tailored systems to 3,000+ global clients across 45 countries.