Multiple Tests Show Gaseous Chlorine Dioxide Proven Effective for the Inactivation of Beta-Lactams

PR Log (Press Release) – Oct 27, 2009 – Clordisys Solutions, Inc of Lebanon, NJ announces that testing has proven chlorine dioxide gas as being effective in inactivating beta-lactams in addition to its status as a sterilant with the US EPA.  Many tests were conducted in conjunction with a leading pharmaceutical company to investigate the possibility of achieving a 3-log (99.9%) reduction of eight different beta-lactams, including Penicillin G and Penicillin V.  The goal of the testing was to develop a method of treating contaminated manufacturing equipment such that it can be reused in non-beta-lactam manufacturing.  Before this study, there was no good way to treat for beta-lactam contamination and equipment needed to be segregated when exposed to beta-lactams.  Multiple chlorine dioxide gas cycles of varying concentrations and exposure times proved to be successful in reaching the goals of the study by achieving a 3-log reduction in all eight beta-lactams.  This allows for the treatment of beta-lactam contaminated surfaces and equipment such that they can be reused safely.
The beta-lactams used in the study included Penicillin G, Penicillin V, Amplicillin, Amoxicillin, Cefadroxil, Cefazolin, Cephalexin, and Imipenem.  A method for the decontamination of penicillin would allow for equipment used in the manufacture of non-penicillin products to be used in case they become contaminated with beta lactams.  It would also allow equipment used in the manufacturing of penicillin products to also be used in the manufacture of non-penicillin products upon decontamination.  This increase in the workload lessens the capital cost of equipment and overall footprint necessary for a facility.

About Chlorine Dioxide
Chlorine Dioxide gas is a leading method for decontamination today because of its properties as a true gas at ambient temperature, its tight process consistency, and its broad spectrum of efficacy against a wide range of organisms and compounds.  Chlorine dioxide gas has been approved for use as a sterilant/decontaminant by the United States Environmental Protection Agency.  In its highest profile use, chlorine dioxide gas was selected to decontaminate the Brentwood postal sorting facility and the majority of the Hart Senate office building after the anthrax contaminations in 2001.  Chlorine dioxide gas has also been used to decontaminate hospitals, surgical suites, laboratories, animal breeding facilities, processing tanks, isolators, biological safety cabinets, and many more applications in the life science, food safety, pharmaceutical, and research industries.
About the Data
An outside laboratory was commissioned for recovery testing of the beta-lactams after exposure to chlorine dioxide gas using liquid chromatography (LC) and mass spectrometry (MS).  The 3-log reduction goal was based off of previous studies done by the pharmaceutical manufacturer which showed that a 3-log reduction is the maximum level of inactivation that can be shown for some beta-lactams.  This inactivation level is also consistent with the level of inactivation deemed suitable for other chemical inactivations, such as for endotoxins.

Results
The test study determined that beta lactams required an exposure of at least 7200 ppm-hours to achieve a 3-log reduction using chlorine dioxide gas.  Multiple cycles showed this under varying concentrations and exposure times.  By proving chlorine dioxide gas effective as a decontaminating agent against penicillin, the goal of the testing has been achieved.  Penicillin contaminated equipment and facilities can now be decontaminated and reused to manufacture non-penicillin products.  This saves manufacturing companies from having to purchase new capital equipment if their equipment gets contaminated or shifts in production occur.  It also allows for a way to routinely decontaminate equipment to minimize the risk of cross-contamination and help to protect the millions of people who have penicillin allergies.  Utilizing this information, it would be possible to “recycle” penicillin-manufacturing facilities rather than demolish them when production shifts. This would be a large, cost-savings opportunity.

More information can be found at www.clordisys.com