CHALLENGE TEST OR STUDY OF PRESERVATIVE EFFICACY
- Performed according to Pharmacopoeia.
- Possibility of “in house” pathogens and re-inoculation.
STABILITY AND COMPATIBILITY
Our climatic chambers, with controlled humidity and temperature, allow us to design stability studies of medical device according to ICH guidelines.
- ACCELERATED STABILITY: predicts the estimated shelf life of the sample. It is essential to perform in parallel a real stability.
- LONG-TERM STABILITY: performed for 2 years, although this period can be extended.
- PHOTOSTABILITY: performed on new formulations or new active ingredients in order to demonstrate that the product is not altered when exposed to light.
- STABILITY IN USE: to be consulted.
Dr. Goya analysis offers its clients:
- Advice on the design of stability studies.
- Conservation of samples under controlled conditions.
- Control of the critical parameters of the stored products according to the established sampling plan.
- Elaboration of the final report of the stability study with an evaluation of the results obtained, proposing a specific shelf life for each product according to the results obtained during the test.
BIOCOMPATIBILITY / TOXICOLOGY STUDIES
- Dermal, mucosal and ocular irritation.
- Acute dermal toxicity.