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Expert Stability Chamber Qualification for GMP, GLP, & Life Science Facilities

Stability chambers play a critical role in pharmaceutical, biotech, and life sciences industries, ensuring controlled environmental conditions for product stability testing. However, regulatory compliance requires more than just proper operation—it demands rigorous qualification protocols to verify chamber performance.

At Quantus, Inc., we specialize in comprehensive Stability Chamber Qualification Services to ensure compliance with ICH Q1A, GMP, GLP, USP, and ISO 17025 standards. Our scientifically validated approach guarantees that your chambers meet strict regulatory requirements while maintaining temperature and humidity stability for accurate and reliable product storage conditions.

Why Stability Chamber Qualification is Essential

Stability chamber failures can lead to product instability, costly deviations, and compliance risks. Our qualification services provide:

  • Regulatory Compliance – Meet FDA, ICH Q1A, and GMP guidelines
  • Performance Validation – Ensure ±2°C temperature uniformity and ±5% RH humidity stability
  • Accurate Temperature Mapping – Identify hot and cold spots with validated sensors
  • Data Integrity & Documentation – Ensure complete audit readiness

With Quantus, you don’t just qualify your chambers—you build a foundation of reliability for your stability testing programs.

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Frequestly Asked Questions

How often should stability chambers be requalified?

Regulatory guidelines recommend conducting requalification annually or whenever significant changes occur, such as sensor replacement, chamber relocation, or system upgrades. Regular requalification ensures continued compliance with FDA, ICH Q1A, and GMP requirements.

What are the key parameters tested during stability chamber qualification?

Stability chamber qualification focuses on temperature uniformity, humidity stability, and recovery time. This involves verifying that the chamber maintains ±2°C temperature and ±5% RH humidity across all test conditions.

    

Do I need qualification if my chamber was previously validated?

Yes, ongoing qualification is required to meet compliance standards. Changes in chamber components, software updates, or environmental conditions may impact performance, requiring a requalification study to maintain compliance.

How long does the stability chamber qualification process take?

The duration depends on the chamber type and the extent of testing required. Installation and Operational Qualification (IQ/OQ) typically take 1-3 days, while Performance Qualification (PQ) may require 7-14 days for full data collection and analysis.

What documentation is provided after stability chamber qualification?

We provide a comprehensive qualification package, including protocols, raw data, calibration certificates, and a final qualification report. This ensures complete audit readiness and compliance with regulatory requirements.

What clients are saying

  • I am very pleased with the services provided. The technicians are exceptional to work with, and the customer support team is incredibly responsive and accommodating. The pricing offers excellent value for the services provided.

    Century Therapeutics Drew

  • The technicians here do an outstanding job. I truly appreciate the responsiveness of the customer support team and their proactive approach to scheduling.

    Ellume Ken

  • Everything is going great with the services. The technicians are top-notch – professional, honest, and very solid in their work. They provide excellent communication and feedback.

    RegenXBio Blake

  • Working with Quantus to resolve the disorganization of previous 3rd party reports. I have received positive feedback on the work Quantus is doing. We're looking forward to a meeting with the top management and business development teams to gain more feedback and develop additional controls.

    Christiana Care James

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