Key Selling Points

• ICH Q1A Compliance: Designed to meet ICH Q1A stability testing guidelines, ensuring regulatory acceptance.
• High Precision Control: Temperature uniformity ±2.0°C and humidity uniformity ±3.0%RH for stable, reproducible conditions.
• Complete Data Traceability: Automated data logging and MES integration support full traceability for audits.
• Pharmaceutical-Grade Build: SUS304 stainless steel interior, easy to clean and resistant to contamination.
• Long-Term Reliability: Designed for ≥5 years of stable operation, backed by remote service support.
• Multi-Standard Capability: Also supports testing to other international standards, such as ISO and ASTM.

Technical Specifications

Models and Options

Available in four standard sizes: ETQ7025 (250L), ETQ7050 (500L), ETQ7100 (1000L), and ETQ7200 (2000L). Each model offers the same performance parameters, with larger volumes for higher-capacity testing.

Materials and Structure

The interior is constructed from SUS304 stainless steel for high corrosion resistance and easy sterilization. The exterior is cold-rolled steel sheet with a durable spray coating. The chamber features an internal radiation shield and servo cooling flow control to maintain uniform conditions.

Applications

Specifically used for long-term stability testing of vaccines, serum, and biological products in the pharmaceutical industry. Also applicable for other regulated industries requiring precise environmental control, such as biotechnology and medical devices.

Case Study

Our chamber has been deployed at a Large Domestic Pharmaceutical Group in China for stability testing of vaccines and biological products. The system has been running long-term and fully complies with ICH Q1A standards, providing complete data traceability and helping the client pass GMP certification.

Customization

We offer customization options such as additional data logging channels, specific port configurations, and validation services to meet GMP requirements.

FAQ

• Q: Does this chamber meet ICH Q1A guidelines? A: Yes, it is designed to comply with ICH Q1A stability testing conditions.
• Q: Can I get a version with higher humidity control? A: The standard model offers humidity control from 10%RH to 98%RH, which is sufficient for most stability tests.
• Q: Is the chamber 21 CFR Part 11 compliant? A: The data logging system can be configured to meet 21 CFR Part 11 requirements. Please discuss your needs with our sales team.
• Q: What is the minimum order quantity? A: MOQ is one unit, but we offer discounts for multiple units.
• Q: Can the chamber be used for both R&D and production? A: Yes, it is suitable for both development-scale and production-scale stability testing.
• Q: What after-sales support do you offer? A: We provide installation, commissioning, training, and remote service support.

Inquiry Information

For pricing, delivery, and customization, please contact our team with your specific volume and feature requirements.

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