Implementation of sterility packaging for sterilization
26/03/2025, 09:30 · Room 4 · EN
AM presents a case study focusing on the optimisation of autoclave sterilisation processes in order to fully align with Annex 1 requirements. The customer's key challenge lies in the packaging of machine parts avoiding risks of contamination, tears and perforation and humidity after sterilization cycle.
Introduction: how AM deals with customer’s requests about alignment of packaging process to Annex 1 requirements.
- Customer’s request
- Choice of raw materials in pharmaceutical packaging production: Tyvek® vs Medical Paper
- Decontamination of raw materials from viable and total particles with the proprietary Safe4Clean® system
- Feasibility study to ensure appropriate packaging shapes and sizes
- Availability of supporting documentation
- Finished product release
- Conclusion: achieve 100% alignment to Annex 1 requirements through an innovative production process that guarantees the highest quality.
Case Study: process and features
- Analysis of production requirements and processes through inspection in
production
- Issuing of feasibility study
- Development and design phase of a dedicated sampling kit and
dimensional testing of Tyvek®-PET/PP heat seal bags, Tyvek® covers and bags
- Validation of customized Tyvek® productsAgenda
- Case study scenario
- Material specifications and loads
- Challenges and URS
- Production activities
- Solutions