Independent research demonstrates the extreme safety of Bormioli Pharma’s bottles manufactured with Loop Industries’ 100% recycled, virgin quality PET

Bormioli Pharmahas presented an independent study[1] demonstrating that bottles made with 100% recycled, virgin-quality Loop™ PET resin contain zero extractables[2] with toxicological relevance, making this plastic packaging solution one of the safest for pharmaceutical applications.

The results of the independent research are extraordinary, confirming that bottles manufactured with Loop™ PET exceed the performance of bottles made from virgin PET which already guarantee full compliance with European Pharmacopoeia extractable limits by a margin of about 90%[3].

The research was conducted by the specialized laboratory Lab Analysis and commented on with a report by the Mario Veronesi Technopole Institute of Mirandola (Modena, Italy), part of the Democenter-Sipe Foundation, and represents a further breakthrough for the adoption of sustainable packaging in the pharmaceutical industry.

"The analysis has confirmed that the pharmaceutical packaging bottles manufactured with Loop™ PET resin represent today's golden standard for the pharmaceutical industry from a safety point of view, in addition to environmental performance" commented Andrea Lodetti, CEO of Bormioli Pharma. "With even more pharma companies mentioning low-impact packaging targets in their Sustainability Reports, we are proud to make available a robust, premium-quality solution to facilitate the transition."

"The complete and solid scientific tests that have been ran gave an unambiguous result: the bottles manufactured with Loop™ PET resin do not release any substance deemed of toxicological relevance, despite being exposed to a variety of extraction conditions, also including one worst-case scenario. For this reason, we can affirm that this material is a secure and reliable option for pharmaceutical applications" commented Professor Aldo Tomasi, Scientific Director of the Mario Veronesi Technopole Institute of Mirandola.

“The pharmaceutical industry demands the highest standards of safety and performance for their packaging solutions. The results of this study showcase the exceptional performance of our Loop™ PET and demonstrates that it surpasses the rigorous requirements of pharmaceutical packaging applications. By providing an innovative packaging solution and sustainable alternative to virgin PET that is reliable and ensures product safety, we are addressing the critical needs of the pharmaceutical industry” commented Daniel Solomita, Founder and CEO of Loop Industries.

The analysis was conducted using tools such as mass spectrometry and various solvents, with five different solutions, one of which was particularly aggressive - a 50% isopropanol solution - to simulate the bottle's performance under the most challenging environmental conditions, comparing the results with the requirements of the USP and European Pharmacopoeia.

In 2023, Bormioli Pharma reached a quota of 45% low-impact[4] materials in the products sold, getting closer and closer to the goal of 50% by 2025.

[1] Report “Substances leached from FI8089, a primary packaging material made from Recycled Polyethylene Terephthalate (R-PET after chemical/advanced recycling LOOP BOTTLE 01 by LOOP), when exposed to various simulating solutions” released on 10th January 2024 and commented by Prof. Aldo Tomasi. The report is available upon request for Bormioli Pharma’s customers.

[2] Extractables are chemical entities that can be extracted from packaging into a drug formulation under forced conditions, potentially interacting with medicine efficacy.

[3] Data from the report “Safety evaluation of 15 ml pet amber bottle used as primary packaging of pharmaceutical products. Chemical characterization and toxicological assessment of leachables and extractables” released on 6th April 2022 and commented by Prof. Aldo Tomasi. The report is available upon request for Bormioli Pharma’s customers.

[4] Including recycled glass and plastic, bio-based plastic and advanced polymers, such as the one coming from the transformation of CO2.