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 (Vcpc) 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.
- © PDA, Inc. 2018
PDA members receive access to all articles published in the current year and previous volume year. Institutional subscribers received access to all content. Log in below to receive access to this article if you are either of these.
If you are neither or you are a PDA member trying to access an article outside of your membership license, then you must purchase access to this article (below). If you do not have a username or password for JPST, you will be required to create an account prior to purchasing.
Full issue PDFs are for PDA members only.
Note to pda.org users
The PDA and PDA bookstore websites (www.pda.org and www.pda.org/bookstore) are separate websites from the PDA JPST website. When you first join PDA, your initial UserID and Password are sent to HighWirePress to create your PDA JPST account. Subsequent UserrID and Password changes required at the PDA websites will not pass on to PDA JPST and vice versa. If you forget your PDA JPST UserID and/or Password, you can request help to retrieve UserID and reset Password below.