Your industry, our focus
The ageing population, upcoming medication of emerging markets and rise of chronic diseases are the main drivers of increasing demand of pharmaceuticals. Manufacturers of pharmaceuticals have to assess the viability and ruggedness of packaging options for each specific product they intend to manufacture.
The packaging's key function is the protection of medicine from external factors such as heat, moisture, oxygen, UV-light and contamination by chemicals or microorganisms. Nevertheless packaging must not release any chemicals to pharmaceuticals which may alter the composition or influence drug efficiency.
To fulfil these demanding requirements pharmaceutical packaging must comply with various pharmacopeia standards as well as test protocols:
- European Pharmacopeia defines compositional requirements, test procedures as well as acceptance criteria in section 3 on materials for containers (section 3.1), containers (section 3.2) and as from 2020 also distinctly for several medical devices like syringes or transfusion sets.
- US Pharmacopeia follows a comparable structure as USP 661.1 defines requirements for the plastic materials while USP 661.2 addresses plastic packaging systems.
Both standards require appropriate chemical assessments, including leachable and extractable testing and toxicology assessment.
The process of selecting and validating the appropriate packaging for bio/pharmaceutical products takes a significant effort. The pharmaceutical industry has to assess the viability and ruggedness of container/packaging options for each specific product they intend to manufacture.
Your key partner in supporting the analytical requirements of this process can be Eurofins BioPharma Product Testing.
We provide various testing for container and packaging properties, including container specific testing such as ID, moisture permeability and integrity. We can provide accelerated temperature storage to challenge the containers or packaging in order to meet USP guidelines and ensure product safety throughout the product’s shelf life.
In addition, we offer a full service for Extractable and Leachable studies which are commonly performed to evaluate the potential for various chemicals to migrate from container closure or manufacturing systems into pharmaceutical products.