Stability

Products that enter the worldwide market need to comply with a spectrum of tests that are necessary to qualify it as suitable for specific climatic conditions. Our stability experts deep dive into managing studies for each market and distribution route.

Stability Storage and Testing
  • Full range of stability testing and storage services
  • Special storage conditions customized to a client’s specific needs
  • Dedicated staff and specifically designed stability software providing total management of stability programs including timely reports, interpretations and recommendations
  • Development of stability study designs in order to meet all stability testing requirements
ICH Conditions
  • Environmental conditions for all ICH climatic zones including storage at -20°C, 5°C, 25°C/40%R.H., 25°C/60%R.H., 30°C/65%R.H., 30°C/75%R.H., and 40°C/75%R.H.
  • Qualified and validated chambers with dedicated metrology personnel for regular chamber maintenance to assure continuous peak operating performance
  • 15,000 cubic feet of storage capacity including backup chambers that are monitored 24hrs/7 days by dedicated stability monitoring software
Photostability Studies

We perform studies in a fully validated chamber in order to respect ICH Q1B guideline, Option 2. Protocol assistance and study design is also available.

In-use Studies
  • Protocol design and execution of in-use studies of multidose products after opening of a container, reconstitution of a powder, or dilution of a solution
  • Execution of in-use studies in a microbiological laboratory environment in order to mimic a hospital/pharmacy setting as for vaccines
  • Execution of studies can also be performed within the ICH climatic long-term world zones such as 25°C/60%R.H., 30°C/65%R.H., and 30°C/75%R.H. to mimic the actual condition of use
Thermo-cycling and Custom Studies

We can design protocols and execute transportation studies in order to comply to Health Canada, the FDA and other regulatory Authorities’ requirements for the transportation of products within the same country, or from one continent to another. We also offer custom protocol designs and executions for specific stability requirements, including bulk holding studies and label studies.

Stability Study Protocols/Reports and Trends/Statistical Reports

We design customized global stability testing protocols, from the development stage to the commercialization of a product. These are supported by interim stability reports and annual product reviews to comply with worldwide regulatory requirements. Statistical interpretation of stability data based on ICH Q1E for trending purposes and stability study effectiveness strategies is also available.

Controlled Substances
  • Licensed and inspected by Health Canada for the handling of controlled substances (narcotics and precursors)
  • Licensed and inspected by Health Canada for analytical testing and storage of cannabis products
  • Services include ICH storage and the testing of precursors, narcotics and cannabis products in dedicated vaults, stability chambers, and storage areas

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