Rapid Microbiology
Rapid detection of microbial contamination in pharmaceutical and food and beverage environments demands highly sensitive and reliable technologies. Today, using rapid detection methods for routine testing is still a challenge for many industries. Culturing and plating methods are the oldest bacterial detection techniques yet continue as the standard detection methods. These methods require several days for results because they rely on the time it takes for microorganisms to grow and to multiply in order to be visible colonies. Over the two past decades, many technologies have been developed in the field of rapid detection, but evaluating, validating and implementing rapid microbiology test methods are usually expensive, complex, painful and time consuming tasks.The new Milliflex Quantum rapid detection system was developed to eliminate these main roadblocks for easier and faster rapid microbiology adoption in Pharmaceutical and Biopharmaceutical industries. It uses an established staining technology to rapidly detect contamination. Convenient and sensitive for the quantitative detection of contaminants in filterable samples, the system is based on a universal enzymatic fluorescent staining of viable and culturable microorganisms. It combines simplicity, ease-of-use and cost effectiveness to monitor microbiological contamination in final products, water for injection, raw materials and the manufacturing environment.
The non-destructive Milliflex Quantum system not only delivers rapid test results, it also enables customers to continue to grow the microorganisms in order to identify them using any standard ID technology. The majority of rapid test systems are destructive in nature and offer only limited capabilities for investigation and identification of microorganisms in case of a contamination event. This can cause serious problems during your investigation and add to the complexity of implementing an appropriate root cause analysis and corrective/preventive action (CAPA) plan.
With the Milliflex Quantum system, QC personnel can recover any microorganism detected after re-incubation. Microorganisms can then be collected for further identification using existing ID methodologies (biochemical, morphological, nucleic acid analytics, etc.).
Click here if you need to identify microorganisms after rapid detection. If you need a system that both detects and enumerates, click here for more information.
Monitoring pharmaceutical bioreactors for Mycoplasma is critical. A different approach to the early detection of Mycoplasma uses nucleic acid technologies (NAT). These non-culture based methods are highly sensitive and specific. . As an example the Real-Time Transcription-Mediated Amplification (TMA) technology is a nucleic acid based method that amplifies ribosomal RNA (rRNA) to detect targeted Mycoplasma contamination within 4 hours. One Mycoplasma cell can contain up to 1,000 copies of rRNA. The abundance of rRNA translates into assay robustness and a greater potential for single cell detection.
Millipore and Gen-Probe formed an alliance to develop, manufacture and commercialize on an exclusive basis nucleic acid testing (NAT) products for fast, sensitive and reliable Mycoplasma detection results.Coupled with Gen-Probe’s Background Reduction Technology (BRT) protects the sample and assay from contamination that could lead to false positive results. The membrane based sample preparation device ensures any Mycoplasma present in up to 20 mLs of bioreactor sample is captured. Real-Time TMA targets abundant ribosomal RNA to increase sensitivity and avoid false negatives. A full system internal control detects sample preparation or operator error and matrix inhibition. The MilliPROBE system for Mycoplasma was recently launched from these two industrial leaders in microbiology.
Screening for Mycoplasma contamination in tissue culture facilities is a major concern. It is estimated that up to 35% of R&D cell cultures are contaminated with Mycoplasma. The MTC-NI is a non-amplified nucleic acid detection method that is ideal for rapid screening of tissue cultures for Mycoplasma contamination.
The patented Hybridization Protection Assay assay format from Gen-Probe, in which a labeled DNA probe is hybridized to the conserved region of the released rRNA of the target organisms, reduces the time to result dramatically. During detection, the bound probes will produce chemiluminescence signals presented as Relative Light Units (RLUs) where a positive signal is defined as a value above a certain threshold value.
* Real-Time Transcription-Mediated Amplification (TMA) is a technology of Gen-Probe Incorporated.
Pharmaceutical Quality Control
Beverage Analysis
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