ESR’s Stability Facility is a dedicated facility for the storage of medicines, and other products and materials, for the purposes of determining shelf life and/or expiry date. Our Stability Facility maintains chambers that are compliant with recommended temperature and relative humidity conditions, as set out in the ICH guideline Q1A (R2) (external link) , as follows:
- 25°C ± 2°C / 60%RH ± 5%RH
- 30°C ± 2°C / 65%RH ± 5%RH
- 40°C ± 2°C / 75%RH ± 5%RH
The Stability Facility is located in a secure environment, and is monitored on a 24/7 basis all-year-round to ensure that the conditions within the chambers remain constant. The Stability Facility is GMP certified, and is one of very few facilities within Australasia to meet the strict requirements for this accreditation.
The Pharmaceutical Programme offers stability storage services only, where samples are returned to the client at the end of the predetermined time, or we are able to perform analytical and microbiological testing as part of integrated storage and testing services.
Our clients use our stability storage services for products and material during development, to meet pre-marketing requirements, and as part of the on-going quality control of established products. We are also able to assist in the development of stability trial protocols to ensure compliance with international regulatory requirements.