Phacilitate working group - standardising tubing connectivity

Phacilitate Working Group Report: Standardising Tubing Connectivity

A summary report of the working group for sterile tubing connectivity meeting to discuss guidance documentation
On September 11th 2018 at Phacilitate Leaders Europe, the working group for sterile tubing connectivity met to work on the objective:

“Plan an approach to developing guidance documentation for advanced therapy system development stakeholders”

This report summarises the meeting, which began with worked examples that included issues associated with sterile tube connections. A cause and effect diagram was constructed around the issue of developing sterile connections that are “closed, aseptic and cost-effective”.
Phacilitate working group report - standardising tubing connectivity

The meeting closed with a general discussion around the key enabling issues of performance, tube dimensions, tube and fitting properties and proprietary access. A series of recommendations emerged that would be highly beneficial to advanced therapy developers:
  1. test protocols are performed by sterile connector suppliers, enabling developers to have greater confidence that the sterile connectors they are selecting are compliant with an agreed, common, minimum standard
  2. produce a guidance paper outlining good design practice for tube sets that will have connections via sterile welding: including material compatibility tube diameter and thickness compatibility, length of free tube for in-situ welding etc.
  3. produce a tube size guidance paper identifying preferred diameters that facilitate joins and interfaces
  4. produce a tube material guidance paper identifying preferred materials for use in cell and advanced therapies operations
  5. review the BioPhorom Operations Group (BPOG) recent tool kits and guidance on leachables and extractables. Some conditions may not be relevant, but these could be adapted to cell therapy application

See the 14-page report for full details of the discussions and recommendations.