Articles
Deactivation Of Single-Use Bioprocessing Systems Using Aqueous Chlorine Dioxide
August 21, 2009
•Feature Article: Deactivation Of Single-Use Bioprocessing Systems Using Aqueous Chlorine Dioxide
By Barry Wintner, Kenneth Bibbo, Anthony Contino, James Crawford, and Gary O'Neill
The biopharmaceutical industry has found multiple process uses for disposable containers. They include flexible containers with integral mixers such as the "onetouch" mixing technology from HyNetics brand (www.hynetics.com) that can be used to prepare media, buffers, IV solutions, and homogeneous suspensions such as adjuvant vaccines. Systems are available to accomodate 30–10,000-L flexible bag sizes.
As with any other innovation, new challenges are identified as our industry proceeds through the adoption life cycle for disposable processing systems. One set of challenges is associated with the deactivation of these systems.
But aren't these requirements exactly what we are trying to avoid through the use of disposables? The answer is yes, of course. But it is also true that in some circumstances drug processors will require or prefer to perform some biological deactivation if only for specific unit operations in a process. One example is the final deactivation of certain materials before disposal. Depending on the nature of materials used in bioprocessing, users may choose terminal deactivation of disposables used in specific processing steps. Some relevant traditional methods include gamma irradiation, shredding followed by chemical inactivation, and treatment (incineration at a certified facility) as hazardous medical waste. Highertemperature treatments (e.g., steam sterilization and autoclaving) are not an option with single-use components because of the polymeric materials generally used in their fabrication. When evaluating deactivation options, important performance parameters include biocidal effectiveness, cost, time requirements, convenience, and risk mitigation.Reprinted with permission from BioProcess International 4(6):S52-S56 (June 2006)
Click Here To Download:•Feature Article: Deactivation Of Single-Use Bioprocessing Systems Using Aqueous Chlorine Dioxide
