Stability Storage Solutions
Source BioScience- FDA-registered and compliant to cGMP, MHRA, HPRA and DEA guidelines- has over 30 years of experience offering a full range of Stability Storage Solutions to the UK, Ireland and US pharmaceutical and medical device sectors. Our facilities with 21 CFR part 11 compliant equipment offer long and short shelf life studies under specified ICH or non-ICH conditions. Our extensive Quality Management System provides overall management, accuracy and control over the Stability and Storage of your samples.
Our Stability Storage facility provides protection of your samples when facing internal threats, such as power outages or equipment failure, as well as external threats such as natural disaster flooding or earthquake disruption. You will have the option to reserve space in our stability storage suites in house, or to hold sample overflow should you require a secure holding facility to meet your environmental specifications.
Under the ICH Q1b guidelines, photostability testing is a requirement for photo-sensitive products being produced or under evaluation in pharmaceutical product development. Our photostability testing services are performed in line with the ICH 1Qb specification in normal ambient temperatures of up to 21ºC, with capabilities of achieving a minimum of 1.2 million lux hours and 200-watt hours per square metre in fewer than 14 days.
Thermal Cycling facilitates sample testing to ensure adverse effects can be avoided during product transportation, such as potential damages from deviating conditions, such as temperature changes from shipment to storage. Source BioScience provides a variety of cycling equipment capable of reproducing deviating temperature conditions and cycle at various hour periods without the disruption of product movement between chambers.