Technological watch
Why extractables in sustainable packaging is as safe as other packaging
Roberto Valenti, head of materials development, Bormioli Pharma, highlights evidence that extractables in sustainable plastic packaging is as safe as conventional packaging.
× In 2021, global carbon emissions reached 36.4 billion tonnes of CO2 globally, the highest figure in human history. Moreover, according to the Global Footprint Network, humanity is "using up nature 1.75 times faster than our planet's bio-capacity can regenerate".
In the last couple of years, enhanced interest in more responsible packaging solutions has already resulted in an increase in sales. Bormioli Pharma registered a 20% increase in sales of sustainable plastic products in 2021, compared to 2020, with expectations for a further 14% increase in 2022.
A further push is needed to ensure a quicker transition, allowing the achievement of results in line with the emission reduction agreements.
Bormioli Pharma, a global pharmaceutical packaging manufacturer, has committed to a wide range of actions.
Firstly, it has been investing in the development of pharma-grade packaging solutions that feature a more responsible approach towards the environment. The company has introduced a new range, EcoPositive, that characterises such solutions.
This new offer relies on more than 15 years of research into more responsible packaging solutions for the pharma industry, gathering the wide sustainable offer of the company. These products have been split consistently with 3 different sustainability strategies: regeneration of raw materials, renewable sources and manufacturing with infinitely reusable materials.
To further support the massive adoption of such solutions by the pharma industry, the company has chosen to expose a prejudice still standing in the industry with scientific evidence: the safety of sustainable primary packaging in plastics, in terms of extractables.
For this reason, Bormioli Pharma has commissioned a third-party, certified analysis to provide evidence about the safety of these packaging solutions, starting from rPET bottles. The analysis has been run by a specialised laboratory, Lab Analysis, and then validated by an istitute, Tecnopolo Mario Veronesi, to investigate the level of extractables in sustainable packaging solutions, comparing them with a risk index, to determine whether there is a safe amount that may be present in pharmaceutical formulations.
The analysis consisted of a 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 had run, a subsequent toxicological assessment of the solvents had been undertaken to analyse the inertness of the containers.
The outcome shown unprecedented results: not only did the analysis make 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 by the ISO regulation on biocompatibility. Indeed, in some specific cases, sustainable primary packaging has proved to be even more performant and safer than conventional plastic primary packaging.
This test, commissioned by Bormioli Pharma on a voluntary basis, sheds light on a topic that has been so far rarely taken into consideration by the pharma regulation – and hopes that this analysis could serve as a first step to define a dedicated regulatory framework for low impact, more responsible packaging solutions, and further supporting an ecological transition to take place in the pharma industry.
Back to Search Results Tags Bormioli Pharma Pharma sustainable Extractables and leachables Packaging Latest Issue issue 68 North America issue 24
× In 2021, global carbon emissions reached 36.4 billion tonnes of CO2 globally, the highest figure in human history. Moreover, according to the Global Footprint Network, humanity is "using up nature 1.75 times faster than our planet's bio-capacity can regenerate".
In the last couple of years, enhanced interest in more responsible packaging solutions has already resulted in an increase in sales. Bormioli Pharma registered a 20% increase in sales of sustainable plastic products in 2021, compared to 2020, with expectations for a further 14% increase in 2022.
A further push is needed to ensure a quicker transition, allowing the achievement of results in line with the emission reduction agreements.
Bormioli Pharma, a global pharmaceutical packaging manufacturer, has committed to a wide range of actions.
Firstly, it has been investing in the development of pharma-grade packaging solutions that feature a more responsible approach towards the environment. The company has introduced a new range, EcoPositive, that characterises such solutions.
This new offer relies on more than 15 years of research into more responsible packaging solutions for the pharma industry, gathering the wide sustainable offer of the company. These products have been split consistently with 3 different sustainability strategies: regeneration of raw materials, renewable sources and manufacturing with infinitely reusable materials.
To further support the massive adoption of such solutions by the pharma industry, the company has chosen to expose a prejudice still standing in the industry with scientific evidence: the safety of sustainable primary packaging in plastics, in terms of extractables.
For this reason, Bormioli Pharma has commissioned a third-party, certified analysis to provide evidence about the safety of these packaging solutions, starting from rPET bottles. The analysis has been run by a specialised laboratory, Lab Analysis, and then validated by an istitute, Tecnopolo Mario Veronesi, to investigate the level of extractables in sustainable packaging solutions, comparing them with a risk index, to determine whether there is a safe amount that may be present in pharmaceutical formulations.
The analysis consisted of a 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 had run, a subsequent toxicological assessment of the solvents had been undertaken to analyse the inertness of the containers.
The outcome shown unprecedented results: not only did the analysis make 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 by the ISO regulation on biocompatibility. Indeed, in some specific cases, sustainable primary packaging has proved to be even more performant and safer than conventional plastic primary packaging.
This test, commissioned by Bormioli Pharma on a voluntary basis, sheds light on a topic that has been so far rarely taken into consideration by the pharma regulation – and hopes that this analysis could serve as a first step to define a dedicated regulatory framework for low impact, more responsible packaging solutions, and further supporting an ecological transition to take place in the pharma industry.
Back to Search Results Tags Bormioli Pharma Pharma sustainable Extractables and leachables Packaging Latest Issue issue 68 North America issue 24
This project has received funding from the Bio Based Industries Joint Undertaking under the European Union’s Horizon 2020 research and innovation programme under grant agreement No 837761.
