Proceedings of the 2017 Viral Clearance Symposium Session 5: Facility Risk Mitigation

Abstract

The discussion on facility risk mitigation was included for the first time at the 2017 Viral Clearance Symposium. A few topics were discussed in this session, including sanitization/cleaning against viruses, viral segregation, as well as the definition of a “functionally closed” system.

Virus inactivation by disinfectants is critical for the biotechnology industry. The efficacy can differ, depending on whether applied to surfaces, in solutions, or in gas phases, as well as the respective disinfectants (i.e., peracetic acid/hydrogen peroxide-based, hypochlorite-based, or glutaraldehyde-based).

Most equipment used in the biotech industry can be cleaned or sanitized by alkaline solutions. Many of these methods were studied regarding their virus reduction potential and were defined considering alkaline concentration, time, and temperature.

Virus clearance may be compromised if cross contamination or carryover happens from an early step with potentially a higher level of virus to a later step in the purification process (i.e., after virus removal or inactivation). Critical potential carryover (V_cpc) is defined as the volume of carryover that will significantly affect the overall virus clearance of a purification process. Based on the evaluation of critical potential carryover, mitigation actions can be introduced to avoid such carryover.

Appropriate segregation within manufacturing facilities is required by regulators and utilized by manufacturers to ensure that the final product has appropriate safety margins. However, consensus around basic definitions and approaches related to facility segregation is lacking. To address this gap, the member companies of the Consortium on Adventitious Agent Contamination in Biomanufacturing have begun a project with the goal of developing a definition for a “functionally closed” manufacturing system.

LAY ABSTRACT: The discussion on facility risk mitigation was included for the first time at the 2017 Viral Clearance Symposium. The topics discussed in this session included sanitization/cleaning against viruses, viral segregation, as well as the definition of a “functionally closed” system.

Virus inactivation by disinfectants is critical for the biotechnology industry. The efficacy can differ, depending on whether applied to surfaces, in solutions, or in gas phases, as well as the respective disinfectants.

Most equipment used in the biotech industry can be cleaned or sanitized by alkaline solutions. Many of these methods were studied regarding their virus reduction potential and were defined considering alkaline concentration, time, and temperature.

Virus clearance may be compromised if cross contamination or carryover happens from an early step with potentially a higher level of virus to a later step in the purification process (i.e., after virus removal or inactivation).

Regarding segregation within manufacturing facilities, the member companies of the Consortium on Adventitious Agent Contamination in Biomanufacturing have begun a project with the goal of developing a definition for a “functionally closed” manufacturing system. During this session, the current definition was discussed.