The month of March was particularly busy for AM, with a strong presence at international trade shows and events. These included the Lounges 2025 stood out as a valuable opportunity to present innovative solutions in the pharmaceutical secondary packaging sector. Elena Mantegazza, Product Specialist at Pharmaclean®, participated as a speaker, bringing a case study on how Pharmaclean® packaging solutions respond to the new Annex 1 regulations.
Elena Mantegazza, Product Specialist Pharmaclean® (right) and Sara Marelli, Export Inside Sales, at Louges 2025
Q: Elena, how was your experience at Lounges 2025?
Le Lounges 2025 were a very positive experience. On the one hand, it was a great opportunity to present pharmaceutical packaging solutions Pharmaclean®, meeting the needs for regulatory compliance and innovation. On the other, it was a time to exchange ideas with experts and colleagues about the common challenges we face in the industry. It was inspiring to see how the market is evolving, with an increasing focus on reducing contamination risks and improving sterilization processes.
Q: Tell us about the case study "Implementation of bespoke sterility packaging for autoclave sterilization"
The case study I presented concerned a customized solution for packaging machine parts in a Grade C sterile environment, responding to the requirements of the customer who was operating a filling plant for vials and syringes. The main problem was the use of medical paper as packaging material, which released particles and broke easily. The machine parts, which were heavy and had sharp edges, had irregular shapes; therefore, a customized packaging solution was needed that would allow uniform steam penetration during sterilization.
We then proposed a customized solution in Tyvek®, a material that offers low particle release and high strength, ideal for maintaining product integrity during the autoclave cycle. Our packaging solved these problems, ensuring regulatory compliance without compromising the quality of the sterilization process.
How do the new Annex 1 regulations fit into the context of sterilization?
The new Annex 1 has posed major challenges, requiring specific solutions to minimize the risk of particulate and microbial contamination. One of the major changes is the requirement to use low particle release materials in aseptic production environments. Our work has focused on this very issue, offering customized packaging solutions on customer request that fully meet these requirements. With Pharmaclean®, we have developed a system that not only ensures the protection of products during sterilization, but also ensures full traceability and compliance with international regulations.
How does Pharmaclean® adapt packaging to the specific needs of customers in the pharmaceutical industry?
The approach of Pharmaclean® is highly consultative. Each customer has unique needs, and it is critical for us to do a thorough feasibility study. We analyze in detail the materials to be packaged, weights, shapes, sizes, and how they assemble on the carts to ensure that the packaging solution is a perfect fit. In addition, we offer both standard and customized solutions for every need.
Our work is not limited to design: we produce packaging samples that the customer can test directly, ensuring that the product meets the requirements. We then release the finished product, complete with all the necessary documentation for validation and compliance with current regulations.
Q: How is Pharmaclean® innovating in the pharmaceutical secondary packaging market?
Innovation is a key part of our philosophy. We are continuously improving our packaging solutions to ensure full regulatory compliance and to offer increasingly effective solutions. For example, we will soon launch a new Tyvek®-PET/PP pouch that is another step toward full compliance with regulatory requirements. This new material will provide even greater strength and validated printing that will avoid chemical residues during the sterilization process.
Q: What did the experience at Lounges 2025 leave you with?
The Lounges 2025 were a great experience! Not only was it great to present our innovative solutions, but it was also a time of professional growth, where I was able to engage with colleagues and customers who share our same passion for quality and innovation. I look forward to repeating this experience and continuing to improve our solutions in the pharmaceutical packaging industry.
