In response to the revised EU GMP Annex 1, which introduces more stringent requirements for contamination control and aseptic processing, a leading pharmaceutical manufacturer faced the urgent challenge of upgrading its packaging operations to ensure regulatory compliance and maintain sterility assurance. The main difficulty lay in harmonizing diverse machine workflows within sterile manufacturing environments, particularly with respect to cleanroom classification and risk-based contamination control strategies.
AM delivered a comprehensive, customized solution that integrated advanced packaging technologies with deep regulatory expertise. By implementing tailored Tyvek® packaging systems, AM enabled the client to achieve full Annex 1 compliance while improving operational efficiency. This case study illustrates how AM’s consultative methodology and technical innovation facilitated a smooth transition toward Annex 1 conformity, reinforcing the client’s commitment to quality, safety, and sustainability.
Interactive Workshop Session Topics
Current strategies for Annex 1–aligned sterile barrier system packaging
Customization, innovation, and sustainability in advanced packaging solutions (case study–based)
The role of tailored material transfer systems in achieving measurable sustainability outcomes
Hands-on demonstration