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Stability Storage
and Analysis

ICH Stability Storage and Analytical Support from a Team of Scientific and Regulatory Experts

Whatever stage of your product development journey, stability studies are a crucial element in determining shelf-life, active ingredient efficacy, and the long-term safety and stability of your product. 

Stability study samples in small vials

Storage Studies and Analysis

Stability storage is the placement of samples into environmentally-controlled chambers to determine how the quality of the substance or product varies with time under environmental factors such as temperature, humidity, and light.  

Stability studies are essential in ensuring product safety, efficacy, and compliance. Finding the right partner to work with on creating the appropriate storage study design for your product’s development or compliance needs is critical for your business. We've been offering stability services since 2006. Our stability experts have the experience to work with your in-house scientists to create forward-looking testing strategies and are committed to building a long-term, collaborative relationship supporting your business success.

You will also have access to our scientific subject matter experts, such as analytical chemists and toxicologists, ensuring you have a complete analysis of test data and the right people available to understand deviations and troubleshoot problems to accelerate your project.

 

Stability Storage and Analysis Service at Broughton

  • 60,000 liters of multi-zone ICH stability storage facilities  
  • Over 250 live stability studies with high-quality end-to-end control of samples, from shipping to disposal
  • Experienced guidance on protocol design and management of your stability study program
  • GxP accredited testing laboratories and access to analytical scientists 
  • Clear procedures for documenting deviations, storage excursions, and disaster recovery
  • Onsite alarms and procedures for notifying key personnel of changes in temperature/humidity
  • Onsite backup capacity
Broughton Stability Storage Analysis Samples

Our ICH Stability Storage Facilities

Broughton Stability Storage

We offer multi-zone stability storage in purpose-built walk-in climatic chambers in a dedicated secure facility. 

The chambers are controlled via a fully validated data management system in accordance with GMP requirements and ICH harmonized guidelines for stability testing new drug products and substances. Each chamber is temperature and humidity controlled to +/-2°C and +/-5%RH of its target conditions, with 24-hour monitoring of chamber conditions and immediate notification of deviations.

Our stability team provides professionally managed stability studies for even the most complex dosage forms, APIs, and product types, including orally inhaled and nasal drug products (OINDP), pharmaceuticals and veterinary products, consumer healthcare, and medical devices. 

All projects are assigned a dedicated project lead. We also use our proprietary LabHQ Laboratory Information Management System (LIMS) software to ensure test data is reported promptly and that raw data is retained and controlled securely.

Stability studies can be conducted at several different temperatures and humidity conditions, including real-time, in-use, and accelerated conditions, in accordance with ICH Q1A(R1).

Broughton ICH climatic zones map (1)

The world is split into five different climatic zones, and we have the capacity to cater to each zone with over 40,000L of dedicated storage space for the most common ICH requirements.

In addition to this, we can facilitate customized storage requests with the ability to offer temperature conditions from -80°C up to 70°C with humidity available from 10-80%RH and offer mobile cabinets and freezers to facilitate customizable storage and stress conditions.

Our expert scientists will help to design and execute the stability studies you require to help accelerate your project and ensure its ongoing compliance.

Our Stability Services

Stability Storage

Do you lack the space to house your own stability chambers or require additional storage capacity? Perhaps you need a special storage condition that your own facilities can’t accommodate? We are happy to assist with storage-only requests. Our laboratory experts can pull samples and ship on the same day, accommodate next-day delivery, and we also offer controlled shipping conditions.

Annual Storage Studies

Regulations require license holders to conduct stability studies to monitor product quality during routine manufacture.  We work closely with you to ensure annual stability studies are conducted in line with regulatory requirements and the necessary data is captured and reported to maintain product safety.

Accelerated Storage Studies

Accelerated storage studies are a key part of the development of a new consumer or pharmaceutical product’s stability profile and an efficient way to highlight and then troubleshoot problem areas early so you can avoid costly reformulations or redesigns.
 
We can conduct accelerated studies on your product to preview the potential degradation process in a shorter time frame to speed up the development cycle and help you get your product to market quicker. Early knowledge of stability behavior can save cost and time during pre-market regulatory projects.

Photostability Studies

Providing photostability data is a standard requirement for any new drug application. Whatever your photostability requirements, we have the expert analysis to support your project. 

At the end of each exposure period, we examine physical changes and report any assay and impurities changes that may arise from the photochemical degradation process.  From direct light exposure of the API to exposure of the final packaged product, our scientists can help assess the effect of light on the product and the product container closure system, help troubleshoot any issues, and recommend protective measures against photodegradation for better product safety.

New Drug Development

Stability data is a key aspect of a regulatory submission, providing evidence of your product’s efficacy and safety over time. Our scientific and regulatory consultants are available to collaborate on new drug development projects from raw material selection and identifying suitable intermediates to testing finished products and packaging, including extractable and leachable studies.

Excursion and Transit Studies

When products are manufactured in a different country or shipped overseas, storage conditions in transit can reach outside stability tolerance and pose a risk to product safety, efficacy, and compliance requirements in the country of use.  
We can support this by conducting excursion studies and providing a full analysis of the quality profile of your product during exposure to the rise in temperature and humidity experienced during transportation.

Managing Business Risk and Continuity

Having a plan in place in the event of a disaster or crisis is an essential requirement for all companies and corporate entities.  We offer business continuity support, including detailed transfer protocols that can be executed within an agreed time frame should a disaster occur.  Speak to our laboratory Quality and Operations teams to learn how we can help you mitigate risk and ensure business continuity.

Stability Study Sample Handling

End-to-end quality-controlled processes for the receipt, management, and disposal of samples are essential in Stability Storage projects. We manage this via our Quality Management System (QMS) in line with GMP, GLP, or ISO 17025 requirements for sample management. This includes managing expectations around traceability, temperature controls and data logging, storage, limiting cross-contamination, data integrity, and computerized systems.   

We have been delivering stability storage services since 2007 and have over 250 live stability studies managed in our in-house 60,000-litre storage facilities. We welcome client visits and audits to our facilities to give you the confidence you are choosing the right long-term partner for your business.

Learn more about shipping samples by reading our shipping FAQs
Plain brown box being picked up by woman wearing blue gloves and white lab coat
laptop computer on desk in modern office

Bespoke Record-Keeping Software

Real-time access to your stability data and trend reports through a secure and validated Laboratory Information Management System (LIMS) drives efficiency, ensures regulatory compliance, and provides access to data whenever required. 

We record all test data in our bespoke LIMS (LabHQ), specifically designed by our sister company, Broughton Software, to collate, store, and report analytical data. This system is designed and validated to meet the requirements of FDA 21 CFR part 11 and MHRA Annex 11 for electronic record keeping and signatures. 




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