Wednesday, August 15, 2018

Inactivation of Beta-Lactams

Beta-lactam antibiotics are, by definition, a class of antibiotics which contain a beta-lactam ring in their structure. They are split into various groups depending upon their base structure, with the main groups being penicillins, carbapenems, cephalosporins, and monobactams. Allergic reactions to beta-lactams can be life-threatening. Due to the large number of individuals allergic, the pharmaceutical industry explored a method for their inactivation.   This research was performed such that a contaminated area could be treated and re-used for the future production of non-beta-lactam compounds. This would allow companies to “recycle” beta-lactam facilities instead of demolishing them upon the completion of production.

Testing was conducted using chlorine dioxide gas at various concentrations and exposure times in an effort to achieve the pharmaceutical manufacturer’s required 3-log (99.9%) reduction of eight different beta-lactams on various surfaces. Nine inactivation cycles were tested, with five passing the acceptance criteria beneath U.S. Food and Drug Administration (FDA)-required 0.03 ppm residue detection level. Successful inactivation cycles which achieved a 3-log reduction of all eight beta-lactam compounds all had cumulative exposures of over 7,240 ppm-hours. Further studies validated this dosage for providing a 3-log reduction of all eight beta-lactams tested.

In 2008, a leading pharmaceutical company was looking to renovate a 33-room facility, that had been used for the production of an Imipenem-based product, into a new training facility. Because positive samples for beta-lactams were found in multiple rooms and inside the ductwork, the entire production facility along with its HVAC was to be treated. Chlorine dioxide gas was injected into 24 locations and sampled from 12 locations to ensure fast and thorough distribution.  To ensure that gas was getting into the HVAC system, the recirculation blower was bumped throughout the process. Upon completion, the area was swabbed by the pharmaceutical company. All swabs came back negative proving that no beta-lactams remained, making the treatment a success.  Since that initial facility treatment in 2008, chlorine dioxide gas has been used for this specific application at a number of other facilities worldwide.

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