AM again appeared at the Symposium this year not only as an exhibitor but as a liaison for issues related to contamination control.
In fact, AM opened the Symposium's workshop series with a series of insights and case studies on the main issues related to the introduction of the new Annex 1, in an extremely topical key.
More than two years after the introduction of the new regulations, in fact, AM has observed a significant shift in the priorities of the life sciences sector. Companies are no longer just looking for quality products, but for integrated solutions and specialized advice capable of optimizing time, cost and performance, while ensuring compliance with regulatory requirements. Each production has unique critical issues that cannot be solved with standardized solutions. What is needed is a tailored approach that considers the multiple variables of processes and proposes targeted and effective solutions.
During the event, industry experts shared experiences and best practices to address two key issues:
- contamination control in autoclave sterilization processes - Alessia Gragnato, Microbiology Tech. Expert Quality Assurance at GSK explained, with our Valentina Bianchi, Account Manager AM, the process of developing and validating products for packaging in Tyvek® material
- The qualification of biodecontamination activities in RABS plants - Nicola Lucchesi, QP Farmigea together with our Technnical Service Coordinator Giancarlo Traballi demonstrated the qualification of the biodecontamination process of a RABS through Zherox® b-pack
- the qualification of biodecontamination activities in pharmaceutical workshops-Monica Gunetti, O.U. QP Head of Regulatory Affairs at OPBG Pharmaceutical Workshop with Lavinia Monaco, Chief Sales Officer AM spoke about biodecontamination as a complementary approach to downtime management in advanced therapies.
But that's not all. The workshop also offered a perspective on AM's innovative solutions developed through experience alongside life science companies in the past two years. A unique opportunity to engage with industry experts to gain practical knowledge and strategic updates.
Great turnout, many questions posed to our speakers.
At our booth it was possible to experience first-hand the innovations covered during the workshop and beyond.
From the new Integra technology applied to Pharmaclean® production of autoclave sterilization products, to the Zherox® line for biodecontamination, to the new line of gloves for isolators.
The gloves were installed in a special glove-box, which was filled with our gadgets for the occasion-a completely original way to test their lightness, agility of movement, and tactile sensitivity.
