PUPSIT – Points to Consider

With the publication of the new Annex 1, pre-use post sterilization integrity testing (PUPSIT) of the sterile filter in front of a filling system has been once again emphasized. However, different to previous versions, the regulators added a sentence that it may not be always possible to perform such test and risk assessment tools shall be utilized to find an alternative. PDA and BioPhorum’s task forces on PUPSIT have created a wealth of scientific data; incl. masking studies, data mining, points to consider implementing the test and risk assessment from filter production to end-use. This webinar discusses the pros and cons of PUPSIT as well as the task force findings.

60 minute Online Course November 9th 2023 at 16:30pm IST / 6:00am EST / 11:00am GMT / 12:00pm CET

Maik W. Jornitz

Founder and Principal Consultant of BioProcess Resources

Maik W. Jornitz, Founder and Principal Consultant of BioProcess Resources, is a 35-year veteran of the industry. He is a highly experienced in single-use bioprocesses, aseptic processing, and a subject matter expert in sterilizing grade filtration and filter integrity testing. He has published multiple books, book chapters and over 100 scientific papers on various bioprocessing and facility design topics. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces, including the EU Annex I response team. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV, Bondwell and board member of DIANT Pharma and Sunflower Therapeutics. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities frequently.
In his previous roles, he was the CEO of G-CON for 10 years, he worked 26 years for Sartorius, with his last role being the SVP for Global Product and Marketing Management Bioprocess. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.

Learning Objectives:

• Review of the regulations
• Reason of enforcement
• PDA/Biophorum SFQRM work and results

Masking
Data Mining
Risk Assessment
Best Practice

• New Annex 1 paragraph and interpretation

Who Will Benefit:

Manufacturing
• Operators/Technicians/End Users
• Laboratory/Process Supervisors/Managers

Regulatory
• Validation/QA
• Process Development

Course Schedule:

From 6.00am - 7:30am EDT

Live Training - 60 Minutes

Questions and Answers Session