Biosafety andSingle Use (SU) Bioprocess
TechnologyBrian R. Petuch RBP, CBSP
Merck and Co.
What is Single UseBioprocess Technology?
• Replaces the ‘stainless steel’ equipment:– Bioreactors– Process tanks– Filtration systems– Centrifuges
• Replaces ‘hard pipe’ sanitary connections with flexible heat‐welded tubing connections.
Examples
Shukla and Gottschalk, Trends in Biotech, 2013
Processes Benefitingfrom SU Technology
• Vaccines– Attenuated – Inactivated– Toxoids– rDNA‐based
• Monoclonal antibodies• Therapeutic Proteins• Gene therapy vectors
SU Advantages
• Reduction of inter‐batch cleaning time and labor
• Reduction in cleaning validation requirements• Reduction of utility requirements
– Steam– Cooling water
• Reduced facility infrastructure
SU Biosafety Concerns• Increased infectious solid waste processing• Leaks
– Fluid connections– Process probes
• Overpressure– Process control– Vent filter binding
SU Biosafety Concerns• Risk of total vessel failure
– Aerosol release– Spill response
• Inactivation of liquid wastes
Risk Mitigation
• Rigorous process safety control studies (HAZOPS, What‐If).
• Design of skid containment options• Enhanced suite spill collection options