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Stability Storage Solutions

Our Services

Stability Storage

–80°C to +50°C storage with a full range of humidity control, adhering to standard ICH and custom conditions for R&D. Perfect for preserving the integrity of your critical samples.

Photostability

Ensure your pharmaceutical products meet regulatory requirements with Q1 Scientific's comprehensive photostability testing services, adhering to the ICH Q1B guidelines.

Thermal Cycling

Gain confidence in your products ability to withstand transportation challenges with Q1 Scientific's thermal cycling services, designed to meet ICH Q1A (R2) section 2.1.7 guidelines

Ultra Low Freezer Storage

Safeguard your critical samples with Q1 Scientific's ultra-low freezer storage solutions, offering precise temperature control down to -80˚C.

Disaster Recovery

Protect your stability studies from unexpected disruptions with Q1 Scientific's disaster recovery services, ensuring swift emergency transfer of samples to prevent critical losses.

Managing stability storage in-house can be complex, time-consuming, and resource-intensive.

At Q1 Scientific, we understand the importance of maintaining the integrity of your valuable pharmaceutical and medical device samples. Our cutting-edge stability storage facilities are designed to meet regulatory requirements, ensuring your samples remain safe, secure, and fully compliant.

From disaster recovery to stability storage space management, our expertise ensures compliance, efficiency, and peace of mind. Trust us to safeguard your research with our state-of-the-art facilities and expert care so you can focus on innovation.

Storage conditions


–80°C
50°C
Q1 Scientific

-80°C ± 10°C

Ultra Low Temperature


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.

-20°C ± 5°C

Freezer Storage


At Q1 Scientific, we offer precise and reliable stability storage at -20°C ± 5°C, ideal for preserving pharmaceuticals, biological samples, and APIs. Our solutions ensure temperature stability, regulatory compliance, and scalability, solving your stability storage headache. Trust us to maintain the integrity and security of your valuable samples.

5°C ± 3°C

Refrigerated temperature


Are you struggling with maintaining the environmental stability conditions of temperature-sensitive products? Q1 Scientific provides reliable stability storage at 5°C ± 3°C, ideal for long-term testing of pharmaceuticals, biologics, and vaccines. Our solutions ensure your products remain stable and effective, meeting your critical refrigeration needs and preserving the integrity of your valuable materials.

15 - 25°C

Ambient


Looking for dependable ambient storage solutions? Q1 Scientific provides stability storage at 15-25°C, ideal for long-term storage of pharmaceuticals, medical devices, and certain biological materials. This temperature range, often referred to as ambient or room temperature, helps ensure the stability and efficacy of products that are sensitive to higher temperatures but do not require refrigeration.

25°C / 60% RH

Long Term ICH


Q1 Scientific provides stability storage at 25°C/60% RH, typically used for long-term storage of pharmaceuticals, medical devices, and certain biological materials. This temperature and humidity condition helps ensure that products remain stable and effective over extended periods and is suitable for ICH climatic zones I and II.

30°C ±2°C / 65% RH ±5% RH

Intermediate and Long Term ICH


For intermediate or long-term stability storage of pharmaceuticals and medical devices at ICH conditions, Q1 Scientific offer storage at 30°C / 65% RH. This condition helps to test the stability of products in moderately warm and humid conditions, typical of many regions. 30°C / 65% RH storage conditions are suitable for intermediate and long-term trial conditions for climatic zones I, II, III and IVa.

30°C ±2°C / 75% RH ±5% RH

Long Term ICH Zone IVb


Q1 Scientific offers long-term stability storage at 30°C / 75% RH, perfect for products destined for hot and humid conditions. 30°C / 75% RH storage conditions are suitable for studies specific to climatic zone IVb and ideal for trial batches destined for challenging environments. These conditions are essential for products intended for markets in tropical regions, providing confidence that they will perform as expected despite the challenging climate.

40°C ±2°C / 75% RH ±5%

Accelerated ICH


Conduct accelerated testing, stress studies, and forced degradation studies at Q1 Scientific to simulate high-temperature and high-humidity conditions. This helps predict the long-term stability of products in a shorter time frame. 40°C ±2°C / 75% RH storage conditions are suitable for all ICH climatic zones, making them versatile for global stability testing. These conditions are essential for ensuring that products can withstand the most challenging environments, providing confidence in their long-term stability and performance.

50+°C

High Temperature


Use Q1 Scientific to meet specific testing and storage needs at very high temperatures. Ideal, for those unique cases where only the hottest conditions will do. It is particularly useful for assessing the durability and stability of products under very high-temperature conditions to ensure they can withstand extreme environments. Also for conducting research that requires high-temperature conditions to study the behaviour and properties of materials or compounds. These high-temperature storage conditions provide a rigorous testing ground for products that need to meet the most demanding standards.

ICH Stability Storage Zones


Global Zones

Q1 Scientific is dedicated to supporting your global compliance needs by providing stability storage solutions that cater to all ICH climatic zones. Our facilities are equipped to simulate a wide range of environmental conditions, ensuring your pharmaceutical and medical device samples are tested under the precise parameters required for each zone. Whether it’s Zone I (temperate), Zone II (Mediterranean/subtropical), Zone III (hot and dry), or Zone IV (hot and humid), we offer storage conditions to meet the specific regulatory demands of each region. Partner with Q1 Scientific to ensure your products are robust and reliable, no matter where they are distributed.

ZONE I

Temperate climate with mean annual temperature of ≤15°C and a mean annual partial water vapour pressure of ≤ 11 hPa.

Confirmed Long term Stability Testing Conditions: 21°C/45%RH. Minimum Duration 12 months.

Additional Testing Conditions: Accelerated Ambient 40°C/75%RH. Minimum Duration 6 months.

ZONE II

Subtropical and Mediterranean climate with mean annual temperature of 15°C to 22°C and a mean annual partial water vapour pressure of 11 to 18 hPa.

Confirmed Long term Stability Testing Conditions: 25°C/60%RH. Minimum Duration 12 months.

Additional Testing Conditions: Accelerated Ambient 40°C/75%RH. Minimum Duration 6 months.

ZONE III

Hot and Dry climate with mean annual temperature of >22°C and a mean annual partial water vapour pressure of ≤ 15 hPa.

Confirmed Long term Stability Testing Conditions: 30°C/35%RH. Minimum Duration 12 months.

Additional Testing Conditions: Accelerated Ambient 40°C/75%RH. Minimum Duration 6 months.

ZONE IV

Zone IV a

Hot and Humid climate with mean annual temperature of >22°C and a mean annual partial water vapour pressure of >15-27 hPa.

Confirmed Long term Stability Testing Conditions: 30°C/65%RH Minimum Duration 12 months.

Additional Testing Conditions: Accelerated Ambient 40°C/75%RH. Minimum Duration 6 months.

Zone IV b

Hot and very humid climate with mean annual temperature of >22°C and a mean annual partial water vapour pressure of >27 hPa.

Confirmed Long term Stability Testing Conditions: 30°C/75%RH. Minimum Duration 12 months.

Additional Testing Conditions: Accelerated Ambient 40°C/75%RH. Minimum Duration 6 months.

Expert Sample Management

How We Work with You

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1

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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2

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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3

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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4

Tracking & Monitoring

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

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5

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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6

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.

How outsourcing can transform your stability storage

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Flexible capacity

Enjoy the freedom to scale your stability storage up or down without any minimum contract. Get exactly the amount of storage you need, whenever you need it.

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Manage risk and compliance

Benefit from stability storage at cGMP facilities with extensive validation, quality systems, 365/24/7 security monitoring, backup power and systems.

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Control costs

With Q1 Scientific’s ‘Pay for Use’ model, you can eliminate waste and avoid hidden maintenance, service, and security expenses. Enjoy peace of mind with no unexpected facility costs.

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Complete visibility

Access your sample documentation and upcoming sample pull dates 24/7 through the secure Q1 Scientific portal

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Expert support

Count on our experts for help and guidance, ensuring you navigate any challenges and optimise your stability storage

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Maximise space

Free up valuable space and resources at your site, allowing you to focus on your core operations without the hassle of space constraints

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Save on infrastructure

Reduce your capital investment by minimising the need for extensive storage facilities and infrastructure

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Reliability and trust

Rely on our proven track record and trusted reputation to ensure your samples are in safe hands

Arrange a site tour

Your breakthroughs deserve the right conditions.

Whether you’re looking to discuss your stability storage needs 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.