According to the US Food and Drug Administration, extractables are compounds that can be extracted from the container closure system when in the presence of a solvent. A concentration of such substances, together with other elements, might seriously compromise drug stability, modifying the chemical and physical integrity of the dosage unit.
As the pharmaceutical industry continues to grow and evolve, extractables testing is a critical component of the pharmaceutical industry's efforts to prioritize quality and safety, ensuring one of the key functions pharma containers are designed for.
While extractables analysis is usually run by pharmaceutical companies, pharma packaging manufacturers are increasingly called upon to provide data-based, scientific consulting services to their partners. That’s what Bormioli Pharma has been doing, starting to offer testing of their own products through third-party certified laboratories as an additional, high value-added service.
Indeed, pharma packaging manufacturers are uniquely positioned to provide data-based, scientific consulting services to their partners throughout the value chain. By conducting extractables testing on specific, delicate components of the packaging integrated systems, such as for example rubber stoppers, manufacturers can help identify potential risks and develop solutions that meet the industry's most rigorous regulatory standards, allowing clients to streamline production processes and ensuring thus adherence to the industry's most rigorous regulatory standards.
Moreover, for Bormioli Pharma extractables tests are a primary tool used in R&D to evaluate different options when it comes to a specific solutions, coming back to the client with a proposal that is well grounded and supported by scientific data. Clients could then rely on such analysis – as a footprint or as a full report – to further orientate product-related decisions.
Extractables testing results can be also used as a tool to facilitate the adoption of innovative solutions that combine quality and safety requirements with other industry concerns, such as sustainability. This approach not only benefits the environment but also provides a competitive advantage for companies that prioritise sustainability in their operations.
By providing data-based evidence of the safety of their containers manufactured with post-consumer recycled plastics, Bormioli is leading the way in promoting environmentally responsible product ranges
Bormioli Pharma's decision to commission third-party certified analysis of their sustainable primary packaging solutions demonstrates a strategic vision that prioritizes quality, safety, and sustainability.
By providing data-based evidence of the safety of their containers manufactured with post-consumer recycled plastics, the company is leading the way in promoting environmentally responsible product ranges.
Indeed, Bormioli Pharma has chosen to expose a prejudice still standing in the industry, by sharing with their partners scientific evidence and data validated by certified third-parties: the safety of sustainable primary packaging in plastics in terms of extractables.
A comparative analysis between bottles made from recycled PET and conventional solutions has been run by the specialized laboratory Lab Analysis, and then certified by the Istituto Tecnopolo Mario Veronesi, investigating the level of extractables in sustainable packaging solutions, comparing them with a risk index, a safe amount that is tolerated in pharmaceutical formulations.
The analysis consisted in chemical analysis with the bottles being tested with 5 different solvents, such as water solutions with different pH (2.5 and 9.0), alcoholic solutions with ethanol and isopropanol, and methanol to investigate the presence of nitrosamines. After the chemical analysis has been run, a subsequent toxicological assessment of the solvents has been undertaken to analyze the inertness of the containers.
The outcome has shown unprecedented results: not only did the analysis made evident that these solutions can meet the industry’s most stringent requirements in terms of quality and safety, but it also revealed that these values are up to 150 times lower than the hazard index, calculated on ISO regulation on biocompatibility. Indeed, in some specific cases, sustainable primary packaging have proved to be even more performant and safer than conventional plastic primary packaging.
In conclusion, looking ahead, pharma packaging manufacturers must continue to evolve their role from mere suppliers to strategic partners who can provide data-driven insights and support their partners' business decisions. By doing so, they can help drive innovation, improve patient outcomes, as well as promoting sustainability across the industry. Ultimately, this approach will benefit not only the pharmaceutical industry but also patients and the environment.
