For more than 30 years, Source Stability Storage Solutions has been providing high quality controlled environment equipment and services to the pharmaceutical and biopharma industry. Our stability storage suite provides storage for long term, intermediate and accelerated testing at ultra-low and low temperatures, all ICH conditions and any unique condition that you may need.
Standard ICH 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.
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.
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.
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.
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.