The production of packaging for sterilization processes, especially in light of the new Annex 1, requires a robust contamination control strategy and innovative solutions to enhance safety and efficiency. More than a year after the implementation of the new Annex 1, by thoroughly studying production processes and client needs, Pharmaclean® by AM offers essential and innovative elements that define a new standard in the packaging management.

Risk analysis in sterilization processes
Annex 1 requirements
Implementation to align to new requirements
Choice of materials for packaging:
how to choose the right materials for packaging system avoiding particle release, tears and perforation;
new technology for clean raw materials: Safe4Clean® (raw materials biodecontamination)
Correct method of packaging for sterilization processes
Shapes and dimensions: how to avoid tears and perforation and ensure uniform steam penetration
Traceability: how to trace entire process from packaging to product in use
Process indicators: risk of cross contamination and innovative solutions to avoid them
The advantages of a correct packaging method
Operational time: how to save time in autoclave sterilization process
Repeatability: how to ensure repeatability in sterilization process