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Stability Storage Services

Source Stability Storage Solutions offers a comprehensive outsourced stability storage service from multiple locations in the UK, Europe and the United States of America. Using our 30+ years’ stability storage experience, our environmentally controlled and monitored equipment is varied for all size of trials from large to small. Our GMP standards facilities are mapped, validated and monitored 24/7 for long and short term shelf life studies and a plethora of conditions including ICH conditions.

Conditions

Standard Conditions

400C/75%RH  Accelerated trial conditions for Zones I - IV
300C/65%RH  Intermediate and long term trial conditions for climatic zones I, II, III AND IVa
300C/75%RH  Long term trial conditions for climatic zone IVb only
250C/60%RH  Long term trial conditions for climatic zones I and II
30oC/35%RH Long term trial conditions for climatic zones III
50C Long term trial conditions for cold stored products

 

Refrigerated, Freezer, Ultra Low Temperature Storage

50C Refrigerated storage for long term stability testing for all cold stored products, API
-200C Freezer storage for biological sample
-250C Freezer storage for biological sample
-700C Ultra low temperature storage for biological samples
-800C Ultra low temperature storage for biological samples)

 

Custom conditions outside of the specifications above can easily be accommodated with our own team able to validate each condition on demand.

Our Services

Stability Storage Sample Management

Whether your study is large or small, Source Stability Storage Solutions can assist. Our GMP standards facilities with monitored and mapped equipment offer long and short term shelf life studies under a specified ICH or non-Ich condition. This would include intermediate and Accelerated testing per ICH Q1a (R2)

Our LIMS is designed to monitor each sample within each study from its arrival to our facility, detailing and diarising the pull points based on the study brief. Included within this is the delivery of the product to either our own laboratory testing facilities or to that of an appointed analytical laboratory for testing. Using the accessibility to your own data via our client portal, a full study calendar will be visible for you to view and stay abreast of where your samples are in the study program.

All logistics to and from our facility and any other location can also be catered for upon request.

Disaster Recovery

As the regulatory bodies continue to evolve and increase their requirements, fashions change and now it is a pre-requisite that all companies have a Disaster Recovery Plan in place for auditing purposes. We can offer you a low and high-risk solution to meet your budget and view on risk. Whether you need full redundancy cover or just want us to hold additional samples to call-off, reserve space with us now by contacting our group of experts who will be able to answer all your questions and needs.

Photostability

The ICH Q1B guideline requires photostability testing on new pharmaceutical substances and drug products.

Single batch testing of samples and studies should be repeated depending on the photostability characteristics determined at the time of initial filing and the type of variation or change made.

Full information on how we test can be gained from our team should you require it.

Thermal Cycling

Even though the world is a smaller place, transportation of products is a serious consideration and Thermal Cycling will allow the appropriate tests to be completed to avoid adverse effects when product is transported. Unforeseen weather conditions, natural disasters and more general traffic congestion and aeronautical travel can all be an element of changes in conditions for a product being transported. The completion of a Thermal Cycling study will evaluate the potential effects of the temperature deviation any and every product can experience.

Controlled Drug Licence

Our Rochdale facility is licenced with a UK Home Office Controlled Drugs licence for storage of controlled drugs. Having met the strict guidelines and audits from representatives of the UK Home Office, we have numerous clients storing their products with us. More details can be gathered from our team at Rochdale.