Below is a listing of all sessions the speaker is scheduled to present.
Vice President Technical Operations
|Wednesday, March 30, 2011|
procedures, the industry has continued to experience ongoing incidents of contamination of facilities and equipment. This paper and study evaluates and better explains typical failure modes for ineffective microbial contamination prevention and treatment. Most failures to resolve process and facility contamination can be attributed to shortcomings in conventional microbial monitoring and speciation methods (diagnostics), combined with resulting shortcomings in conventional liquid disinfection (misdirected or sub-lethal decontamination treatment). This study demonstrates how new diagnostic and analytical technologies when used in conjunction with classical microbiological approaches can better pinpoint the root cause and mechanisms of the microbial contamination and in turn, enable a targeted, more effective decontamination treatment rather than a scattered "shotgun" approach.
Accurate and comprehensive knowledge of the entire process flow relative to the recovered EM isolates is part of a thorough microbial control program. The goal is to have accurate and precise data demonstrating where incursion points exist, and control those points to limit or prevent migration into the process flow. Historic identification of clean room EM isolates has been limited to the genus or group-level for most organisms, with some ability to provide species level identification only if needed. Today, many rapid technologies including DNA-based methods are available which can provide a far deeper identification level of microorganisms. This may appear to be an invaluable tool for performing general investigations and trending, and an essential part of any investigation into aseptic excursions and the risk-based analysis required to address those issues. If used appropriately, these technologies can certainly direct management decisions in a more cost-effective manner).
However, this increase in technology also comes with an increase in possible identifications and with the likelihood of identifying a far greater number of "objectionable" environmental organisms (e.g. coliforms, potential pathogens) than ever before including organisms in environments not addressed by conventional application of standard disinfectants. With the enhancement in this technology, the industry and regulators should be prepared with improved procedures to address these findings with rational, manageable approaches and with the ability to determine whether these are 1) correct and accurate Identifications, 2) have meaning as an “objectionable” organism, and 3) develop demonstrated effective solutions for control and remediation. The paper suggests a new, higher standard for monitoring, control and prevention as well as for the best scientifically robust corrective response to a potential objectionable contamination event.