We are Azierta, we conduct complete studies of extractable substances and develop methods to monitor the presence of leachable impurities in the final product.
Packaging materials and manufacturing processes with plastic materials can cause impurities to appear in the finished pharmaceutical product.
In this context, extraction and migration studies are a basic tool used to define the material’s compatibility with the product and its safety for patients.
We offer a comprehensive service of analysis and toxicological evaluation that includes all stages of the process:
1. Evaluation of packaging and production materials
During the first stage, we review the materials used in packaging and production to predict their compatibility with the pharmaceutical product. We do this by performing several studies:
- Specifications of each material: Compliance with pharmacopoeia, types of material, additives used and physical-chemical properties.
- The material’s conditions of use during product manufacturing and storage: Temperature and pressure and sterilisation processes.
2. Extraction and simulation studies
In this stage, we perform extraction studies on the materials to assess their degradation in extreme conditions in order to anticipate any potential impurities that could migrate from the material to the product. This involves:
- Designing a specific study for each material
- Using high-resolution combined analytical techniques
3. Toxicological evaluation
In this phase of the process, we perform a toxicological evaluation of the impurities detected in order to define their toxicological profile and the risk involved for patients. This evaluation is carried out through:
- Literature reviews
- Data migration via Read Across.
- QSAR methods for predicting toxicological end points
4. Toxicological risk analysis
Based on the results obtained in the extraction studies and considering the inherent toxicology of each extractable, we assess the risk posed by exposure to the impurity.
This risk analysis often enables us to circumvent additional studies on the finished product, leading to time and cost savings for the customer.
5. Leachables study
Leachables studies allow us to identify any impurities derived from the materials that may be found in the pharmaceutical product under normal conditions of use.
This process may not be necessary depending on the results obtained in the prior toxicological risk analysis.
We have a specialised toxicological support department made up of a multi-disciplinary team of expert toxicologists accredited by AETOX, EUROTOX y ERT.