Stability Studies and Storage Testing
STERIS Laboratories offer a wide range of cGMP stability studies and storage testing facilities for pharmaceuticals, medical devices and cosmetic products.
A stability study protocol contains sample information, details of the testing program and projected study timeframes. Before reporting data to our Customers, results are statistically evaluated to detect potential trends.
cGMP stability services
- cGMP registration stability studies
- In-house studies and storage management
- Forced degradation testing
Storage of stability testing samples
We offer a wide range of storage conditions and we understand that reliability is a key performance factor in storage of stability testing samples. To ensure temperature and relative humidity during the total stability study’s time frame, our storage rooms are continuously conditioned and controlled. An alarm system will be activated if any condition falls out of specification. At our laboratories, samples can be stored according to ICH conditions, custom stability studies and storage testing is also possible.
Setup of stability studies
- The custom setup of stability studies is possible:
- In general, we edit a study protocol before start up. Also, testing for APIs, clinical trial materials, formulated products
- Tailored reporting: time point and final reports
- All ICH conditions storage
- Custom or specialized conditions
Photo stability studies lightsource
- Suntest CPS, air cooled Xenon arc lamp
- Total exposure area: 560 cm2
STERIS Laboratories also offers support on analytical method development and validation. The analytical method used in stability studies needs to be “stability indicated.” A forced degradation study is an essential tool in developing a stability indicating method. We offer acid-, base-, light-, humidity and heat manipulation.