OFICE S.L. EXPANDS THE STABILITIES DEPARTMENT WITH NEW CLIMATIC CHAMBERS With the acquisition of the new climatic chambers for stabilities tests under GMP* standards, OFICE laboratory maintains its purpose of continuous improvement and its objective of offering the highest quality, reliability, confidence and validity in the analytical results, in order to maintain the satisfaction and adaptation to the expectations and needs of its customers.
Product stability testing is essential to ensure consistently high quality, both in research and development and in industry. The climate chambers purchased meet the ICH** recommendations and can combine temperature and humidity conditions to carry out Long-term, intermediate and accelerated STABILITY STUDIES in different climate zones. Allowing to offer:
– on going stability studies (Once a medicinal product has been placed on the market, stability should be monitored in its final container and according to a continuous and appropriate programme to detect any change in stability according to Chapter 6 of the GMP***).
– stability studies for registration or development (according to ICH recommendations, routinely under accelerated and long-term conditions).
– Other needs in method development and validation, sample preservation, analytical control, …
Partial or complete stability studies can be contracted, in all cases with the advice of OFICE for the design, the delivery of individual reports for each control period and the final report with the compilation of all the data and the conclusions obtained.
The models purchased are MEMERT HPP 108 which feature high precision temperature control from +5°C to +70°C, as well as active humidification and dehumidification from 10% to 90%. Optimally adjusted to the requirements of the stability tests according to ICH**. This allows us to increase and improve the quality of the service that OFICE S.L. offers its customers.
*GMP: Good Manufacturing Practice
**International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.
*** NCF: Good Manufacturing Practice
If you are interested or need more information, please contact us through the following e-mails:
