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Thermal Cycling

Ensure your products withstand real-world temperature fluctuations

Unexpected temperature changes during storage, shipment, and handling can significantly impact product stability, leading to degradation, reduced efficacy, and potential compliance issues. By recreating these adverse environments, we provide valuable insights into your product’s resilience. Our thermal cycling (freeze-thaw) studies ensure your product remains stable and effective from storage to shipment and beyond.

Designed to meet ICH Q1A (R2) guidelines, our thermal cycling testing covers storage, shipment, and subsequent use, giving you confidence in your product’s integrity throughout its journey. Trust Q1 Scientific’s thermal cycling services to ensure your product withstands transportation challenges and meets regulatory requirements.

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Our thermal cycling testing process

Ensuring product stability under different conditions can be challenging. At Q1 Scientific, we alleviate this burden with our thermal cycling process. We collaborate with you to rigorously test your products, ensuring they are ready to meet the demands of any journey and reducing the risk of failure and non-compliance.

Here’s an example of a thermal cycling process at Q1 Scientific:

  • Initial storage: Samples are stored at the recommended 20°C to 25°C.
  • Extreme cold: Samples are placed at -20°C for 48 hours.
  • High heat and humidity: Samples are then moved to 40°C with 75% relative humidity for another 48 hours.
  • Repetition: This cycle is repeated three times to thoroughly test the product’s resilience.

We understand that each product has unique requirements. That’s why we customise our thermal cycling studies to meet your specific needs, ensuring your products are tested under conditions that reflect their real-world use.

Expert Sample Management

How We Work with You

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New Stability Study

Contact Q1 Scientific to discuss your new study and specific requirements. You have complete control over the length of the study, storage conditions, and the number of sample pulls.

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Sample Receipt

Enjoy a seamless experience as we handle all sample delivery logistics to Q1 Scientific, ensuring a smooth and hassle-free process.

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Storing Samples

Upon arrival, we check your samples against your documentation. Samples are assigned a unique barcode for easy tracking, then placed in the specified storage conditions according to your protocol.

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Tracking & Monitoring

Our electronic system continuously monitors and tracks your samples, ensuring they remain in the correct conditions.

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Client Access

Stay informed and in control with our secure client portal, where you can access all relevant data and track your samples effortlessly.

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Sample Return

We notify you of upcoming scheduled pulls and manage the logistics for sample delivery to your site or testing laboratory, ensuring timely and safe returns.

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A complete stability study solution

Stability Storage

Are you running out of stability storage space or struggling with maintaining precise storage conditions? Q1 Scientific is here to solve those problems. We offer ICH and custom temperature and humidity-controlled storage, to keep your samples in optimal conditions.

Our state-of-the-art cGMP stability storage facilities in Belgium, Ireland, and the US provide comprehensive solutions, including –80°C to +50°C storage conditions, thermal cycling, photostability testing, and disaster recovery services.

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Photostability

Ensure product efficacy and safety under light exposure, complying with ICH Q1B guidelines. At Q1 Scientific, we conduct photostability testing on a single batch of material to provide reliable data on how your drug substance or product reacts to light exposure.

Whether performing forced degradation or confirmatory studies, data from our fully qualified, temperature and humidity controlled photostability chambers helps you take proactive steps to ensure product quality and regulatory compliance.

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Thermal Cycling

By recreating the adverse conditions typically encountered during shipment, we provide valuable insights into how your products will react. Our thermal cycling studies are designed to meet ICH Q1A (R2) section 2.1.7 guidelines, ensuring that the storage conditions and study durations are sufficient to cover storage, shipment, and subsequent use. This means you can have confidence that your products will maintain their integrity throughout their journey.

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Ultra Low Freezer Storage

When it comes to storing life-saving vaccines, groundbreaking pharmaceuticals, or delicate biological samples, maintaining their integrity is crucial. Q1 Scientific provides the ideal solution for your ultra-low temperature storage needs, down to -80˚C. At our facilities, we offer all commonly used conditions for biological or vaccine storage:

  • 5°C ± 3°C
  • –20°C ± 5°C
  • –70°C ± 10°C
  • –80°C ± 10°C
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Disaster Recovery

Unexpected events or chamber failures can disrupt your stability studies, leading to critical losses. Protect against unforeseen events with our comprehensive disaster recovery services.

Our disaster recovery procedure ensures the emergency transfer of samples, from individual batches or entire chambers. If one of your stability chambers fails, Q1 Scientific can swiftly take the affected samples, preventing significant interruptions to your stability program while safeguarding your valuable research.

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Speak to an expert

Protect your products from the risks of temperature fluctuations.

Whether you’re looking to discuss your next thermal cycling study or interested in booking a site tour, we’re here to help.

Simply fill out the contact form and our team will get back to you.