AM presented the case study: "Redefining Material Transfer – A Unique and Sustainable Strategy for Annex 1 Compliance in Aseptic Processing"
During Lounges Karlsruhe 2026, one of Europe’s leading events dedicated to cleanroom technologies, sterile processes, and contamination control, AM contributed to the scientific program with a real-world case study on the packaging of materials for sterilization and transfer processes in classified environments.
During her presentation, Annalisa Soldi, Product Manager for Contamination Control Solutions at AM, emphasized that adopting a risk-based approach is now essential to address increasingly complex operational needs while ensuring compliance with regulatory requirements. With the final publication of the new Annex 1 of the European GMPs, the rigorous application of a structured Contamination Control Strategy has in fact become a mandatory requirement for all activities in classified environments.
The case study presented at Lounges 2026 is part of a new production context focused on the dental anesthetics market, where the client company had been using packaging solutions based on medical-grade paper and paper/PET-PE materials. These had revealed significant issues: particle release, frequent damage to the packaging, the use of adhesive tapes and cutting tools, increased operating times, and sterilization processes that were not always consistent. These problems had also led to a non-compliance issue identified during an inspection, making a review of the packaging system necessary.
In response to clear requirements such as reducing handling, optimizing cycle times, safely managing complex geometries, and ensuring full compliance with Annex 1, AM applied its Pharmaclean® approach, which integrates risk analysis, technical consulting, custom design, fitting, qualification, and manufacturing.
Following a thorough feasibility analysis, a custom packaging solution was developed that included covers and bags made of Tyvek® 1421B, as well as pouches and peelable reels made of Tyvek® 1073B/PET-PP, some of which also featured a steam sterilization indicator. The solutions were validated through fitting tests, autoclave testing, and dedicated technical documentation.
The results achieved were tangible: reduced processing times, a drastic reduction in particulate release, resolution of packaging damage issues, minimization of material waste, and greater control over the entire sterilization and transfer cycle.
This case study confirms that sterile packaging is a strategic driver of quality, safety, and compliance. For AM Instruments, participating in the Lounges means becoming part of a highly specialized ecosystem, fostering the exchange of knowledge and the sharing of best practices, in order to offer solutions that anticipate regulatory requirements and truly go Beyond the Invisible.
