Biosafety and Single Use (SU) Bioprocess Technology Brian R. Petuch RBP, CBSP Merck and Co.
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