With the approval of the new Annex 1, autoclave sterilisation processes for getting materials to point-of-use have become one of the most critical challenges for the industry. AM Instruments is responding with a revolutionary innovation: the new Pharmaclean® bag in Tyvek® - PET/PP, designed to offer maximum safety and compliance in the life sciences industry.
The result of an in-depth analysis of the market and customer needs, the new bag is the result of years of experience and a strong commitment to research and development. The result is a product that eliminates contamination risks while ensuring complete traceability.
The new Pharmaclean® bag features an integrated process indicator via a validated printing process, which eliminates the risk of cross-contamination. This solution offers immediate visual verification of the success of the sterilisation process, thanks to indicators placed directly on the surface of the bag, rather than on the seal, as is usually the case, ensuring significant improvement.
But AM Instruments does not stop there. The new bag offers an additional guarantee of traceability by printing the code number and production batch number on each individual unit. In this way we ensure complete traceability of the autoclave sterilisation process and are able, through the production batch record, to trace the raw material supply chain with absolute certainty.
The new Pharmaclean® bags, the only ones in the world made in a Grade C Operational cleanroom with biodecontaminated raw materials through the proprietary Safe4Clean® system, represent the ultimate in quality and efficiency for sterilisation processes.
“We are never content to meet today's needs; our commitment is to anticipate tomorrow's challenges by offering solutions that not only meet regulations, but redefine standards of excellence. The new Pharmaclean® bag, produced in the Grade C Operational cleanroom and 100% aligned with the requirements of the new Annex 1, sets new standards for the category, combining the best peel-ability and lowest particle release with total traceability. An innovation that represents significant added value for the Life Sciences industry.”
Roberto Fossati, CEO of AM Instruments
The new Pharmaclean® bag will be previewed at the AM Instruments booth at CPHI Milan 2024 - 18C29 and will be available on the market in the first half of 2025.