Why is it important to attend?

The ASME BPE Standard provides requirements for systems and components that are subject to cleaning and sanitization and/or sterilization including systems that are cleaned in place and/or steamed in place and/or other suitable processes used in the manufacturing of biopharmaceuticals. This Standard also provides requirements for single-use systems and components used in the above listed systems and components.

This Standard may be used, in whole or in part, for other systems and components where bioburden risk is a concern and applies to:

1. new system (and component) design and fabrication
2. definition of system boundaries
3. specific metallic, polymeric, and elastomeric (e.g.,seals and gaskets) materials of construction
4. component dimensions and tolerances
5. surface finishes
6. materials joining
7. examinations, inspections, and testing
8. certification

This seminar will provide the following:

• Overview of the 2018 edition changes
• Discussion on emerging topics that will continue to drive and develop the leading international standard
• Opportunity to ask our expert about specific challenges

Who should attend?

• Engineers
• Facilities
• Validation
• Quality
• Maintenance