Stability Zones And Stability Conditions By ICH Storage
For the storage of vital and essential pharmaceuticals, in ways that prolong the lifecycle and ensure the functionality of all medications, using stability zones and conditions is standard practice. Based on ICH guidelines and requirements, it’s more important than ever for laboratories involved in clinical trials, pharmaceutical sampling and more to store the drugs they are testing appropriately. How can labs ensure their materials are kept in the best possible condition, even in the long term? ICH stability storage is exactly what’s needed to ensure samples are stored appropriately, safely and securely at all times. Why invest in costly in-house storage systems when turning to the professionals provides you with a far better chance of success?
Read on to find out more about stability zones and conditions, and why they’re an essential part of the trials process that you definitely shouldn’t skip:
Stability Zones: What they are and why they’re necessary
As defined by the International Conference on Harmonization, or the ICH, stability zones are the category of zone that each climate falls into. From these zone specifics, scientists and similar clinical technicians can accurately and effectively perform testing and trials that match the specific requirements and challenges of their particular location. These definitions allow for greater freedom in testing, while still meeting those specific stability requirements to ensure pharmaceuticals are just as effective in different parts of the world or particular climates.
Stability zones are split into four distinct categories:
Zone I – temperate
Zone II – subtropical
Zone III – hot and dry
Zone IVa – tropical
Zone IVb – high humidity and hot
Why outsourcing might be the best choice for your sample storage needs
For many clinical tests and pharmaceutical trials, one of the significant challenges in performing more widespread testing is the ability to store required chemicals in a stable, safe and secure environment. That’s when services like Roylance Pharma are the ideal solution, providing a professional, outsourced option for stability storage that suits a wide range of different environments as defined by the ICH.
Whether standard stability zoning is required, as specific custom conditions need to be met, choosing to work with a specialised service as part of your next stability study can provide that extra degree of accuracy and infallibility that is challenging to achieve internally. The controlled storage of samples is an absolute requirement for many specific studies, especially when it comes to examining the drug product life cycle. Why not use the experts when their professional insight, knowledge and skills are available to you?
How spot-on stability can be achieved
By utilising continually monitored, high-end technology for temperature and humidity control, Roylance Pharma can ensure the top level of safety for all samples in our care. With regular maintenance and backup emergency systems included as standard, your samples are safer with us than they would be anywhere else in the world. For trials where the climate matters to ensure the stability of pharmaceuticals anywhere in the world, choosing a service that takes your work as seriously as you do is the best place to start.
To find out more about our services, or to discuss how we can help support your upcoming trial or testing phase, contact us today.