AM's innovative Pharmaclean® pouch is the ultimate solution for dedicated autoclave sterilization packaging, 100% Annex 1 compliant, clean and traceable.
In a context where autoclave sterilization processes aimed at introducing materials to the point-of-use have become one of the most challenging following the approval of the new Annex 1, AM is responding with a revolutionary innovation: the new Pharmaclean® pouch in Tyvek® - PET/PP, designed to offer maximum safety and compliance in the Life Sciences sector.
Through a careful study of customer needs and an in-depth analysis of the market, AM developed this unique solution, born of field experience and a strong commitment to research and development. The result is a product that eliminates the risks associated with contamination while ensuring full traceability.
The new Pharmaclean® pouch integrates a process indicator through a validated printing process, which eliminates the possibility of cross-contamination. This solution provides immediate visual verification of the success of the sterilization process, ensuring clear evidence because the indicators are placed on the surface of the pouch and not, as is usually the case, on the seal.
But AM goes further. The new envelope offers additional assurance of traceability by printing the lot number and product code on each individual envelope. This feature is a significant step forward in quality assurance and safety for customers.
The new Pharmaclean® bags , the only ones in the world made with biodecontaminated raw materials during production using the proprietary Safe4Clean® system, represent the pinnacle of quality and efficiency for sterilization processes, thanks to features such as excellent peelability, the lowest particle release on the market and total visibility of the sterilized product. Produced in the Grade C Operational cleanroom at the Cesano Maderno (MB) facility, these bags are fully compliant with Annex 1 requirements and feature high cleanliness and traceability, making them ideal for the Life Sciences sector.
