Julie Vickers, Process Subject Matter Expert, Peter Cramer, Process Architecture Subject Matter Expert & Todd Rumsey, Process Discipline Specialist, Jacobs, USA 

A Contamination Control Strategy (CCS) should be implemented across the facility in order to define all critical control points and assess the effectiveness of all the controls. It should be actively updated and drive continuous improvement of the manufacturing and control methods. In the 21st century, it is possible to use appropriate technologies like rapid microbial testing to protect the product and detect rapidly any contaminants, so that decision makers could achieve lean manufacturing, higher throughput and minimal waste.

Juliana Gutierrez, Healthcare Scientific Affairs Manager, Biomerieux Asia Pacific, Singapore

United States Code of Federal Regulations and European Union EudraLex “Annex 1” are in alignment that hold times must be established and validated for 

sterilized equipment. This presentation discusses these practices as well as results of unique experimental data used to support sterile hold times. Because sterile hold times are dependent on the wrapping used, defining the sterilization wrapping system (material of construction and closure method) is essential. To test and confirm sterilization wrapping system performance, STERIS designed experiments using various materials and closure methods over a defined hold time. This unique experimental data is the basis for best practice recommendations for sterilization wrapping systems to assist in validation work for site specific aseptic fill / finish items.

1)      Upstream and downstream development

2)      Manufacturing considerations

3)      Fill finish considerations

4)      Critical QC test

Moderator:
Peiqing Zhang, Strategic Technology Partnership Leader Cell and Gene Therapy, APAC, Pall Corporation, Singapore 

Dr Tony Li, ASQ Certified Six Sigma Black Belt mRNA Platform, Senior Director, WuXi Biologics, China
Rafael Beaus, Global Consultancy Manager, Azbil Telstar, Spain