The Rapid Blog & News

Comparing The Growth DirectTM System Environmental Monitoring Cassettes vs. Conventional Media: Part 1

Posted by Rapid Micro Biosystems

Jan 28, 2015 9:00:00 AM

scientist_comparing_environmental_monitoringEnvironmental monitoring (EM) is one of the critical parts of the overall microbial testing process performed in pharmaceutical manufacturing. With the traditional EM method, microbiologists use standard contact plates. Samples are captured, the contact plate is incubated and the number of colony-forming units are reported.

While the traditional environmental monitoring is a successful component of microbial testing of manufacturing, it is prone to handling and other potential errors. Because of the large number of samples typically associated with environmental monitoring, testing requires a great deal of time and effort from highly trained technicians – scarce resources in an environment that requires ever-greater efficiency and continual growth. A faster, more efficient and less error-prone alternative is the Growth DirectTM System, which automates and accelerates the compendial method using the same sample preparation techniques.

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Topics: Environmental Monitoring, The Growth Direct System, microbial testing

Accelerating Flu Vaccine Production, the Role of Automated, Rapid Detection

Posted by Rapid Micro Biosystems

Jan 23, 2015 2:00:00 PM

A recent article in Bloomberg highlights some of the challenges faced by manufacturers trying to respond to this year’s flu vaccine issues, noting that vaccine production is an “80 year old process now used to inoculate the population.” The article identifies the areas of production and distribution as two opportunities for improvement. 

For production, the article highlights companies that are leveraging innovative methods to “sell vaccines in the US that take just weeks to produce.”   These involve processes that differ from the traditional method of growing the virus by getting it to replicate in chicken eggs, which can take months, and allows the flu virus time to mutate, limiting the effectiveness of the vaccine.

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Topics: Vaccines

Determining Incubation Regime Article Wins George Sykes Memorial Award

Posted by Rapid Micro Biosystems

Jan 21, 2015 8:30:00 AM

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In late December, the Pharmaceutical and Healthcare Sciences Society (PHSS) awarded their 2014 George Sykes Memorial Award to Andrew Sage, Nadine Timas and David Jones of Rapid Micro Biosystems for their scientific paper entitled, “Determining incubation regime and time to results for automated rapid microbiology EM methods”. The paper was published in the European Journal of Parenteral and Pharmaceutical Sciences 2014 Volume 19 Number 2.

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Topics: Environmental Monitoring

Applying Six Sigma (DMAIC) Tools to Routine Water Testing

Posted by Rapid Micro Biosystems

Jan 14, 2015 8:30:00 AM

six_sigma_processesLean and Six Sigma are two methodologies used extensively by manufacturers across industries to remove defects, minimize variability in their processes and reduce waste while increasing customer satisfaction and profits. Six Sigma tools can and have been applied by pharma and biotech manufacturers, who must produce safe, effective, consistent products with increasingly faster cycle times.

For those of you who are not familiar, Six Sigma makes use of the DMAIC method (Define, Measure, Analyze, Improve and Control) as a framework for improvement. That framework can be applied to many business processes to assess and evaluate improvements. Below is a discussion of the application of the DMAIC framework to the application of automated rapid detection technology to water sampling.

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Topics: Six Sigma, The Growth Direct System

Discover the Power of Automated, Growth-Based RMM

Posted by Rapid Micro Biosystems

Dec 19, 2014 8:30:00 AM

power of automated growth based rmmAre you considering purchasing a rapid microbiological method (RMM) for your QC lab? Quality control labs worldwide are embracing rapid microbial methods (RMM) to help streamline workflows, save resources and provide for sustainable and cost-effective growth.

Are you struggling with which method to choose? While there are various methods for rapid detection, automated growth-based technologies such as the Growth Direct TM System simply automate the traditional method. This technology eliminates resources from the testing process, freeing the lab to devote more time to higher value activities. Click below to see the story of Webster, who works in a QC lab performing environmental monitoring testing and is looking for options to save time and energy in colony enumeration.  

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Topics: The Growth Direct System, rapid microbiological method, RMM, QC Labs

Rapid Micro Biosystems Announces Availability of Bi-Directional LIMS Integration

Posted by Rapid Micro Biosystems

Dec 17, 2014 7:00:00 AM

Lowell, MA  – Rapid Micro Biosystems, a leading provider of automated, non-destructive, rapid microbial detection, today announced the general availability of two-way integration to laboratory information management systems (LIMS) through its industry leading Growth Direct™ System. The new capability allows quality control microbiology labs to save time and reduce errors associated with entry of final test results of environmental monitoring, bioburden and sterility tests.   

The bi-directional LIMS integration uses widely supported comma-separated (CSV) files to communicate, allowing integration with most LIMS systems.  Due to the flexibility provided by the communication method, integration can be aligned to the specific needs of the quality control microbiology lab both initially and in the future.  

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Topics: LIMS, Integration, Press Releases

Reaping the Benefits of LIMS Integration

Posted by Rapid Micro Biosystems

Dec 9, 2014 2:00:00 PM

reaping the benefits of LIMS integrationIn addition to the rise of lean initiatives throughout the last few decades, businesses in most industries have transitioned from using siloed, departmental technologies toward more integrated systems. Pharmaceutical quality control labs have been slow to integrate with the rest of the business, often due to a lack of available technologies. However, solutions are now available that help integrate microbial testing results with the rest of the company.

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Topics: LIMS, RMM, Rapid Microbial Methods

New Technical Monograph on Bio-contamination from PHSS

Posted by Rapid Micro Biosystems

Nov 26, 2014 9:00:00 AM

new technical monograph on bio-contaminationContamination control is a vital part of producing safe, effective and sterile pharmaceuticals. Previously, we provided an overview of the PHSS Technical Monograph #20 “Bio-contamination characterization, control, monitoring and deviation management in controlled/GMP classified areas,” which offers guidance to pharma managers developing plans to minimize contamination in their operations. This week, we’ll delve further into the paper and discuss additional details.

The document details control strategies that include manufacturing, quality and contamination control and stresses that they’re interconnected and a robust strategy should blend all three, considering both facility design and daily operations. The control strategies are focused on, “product quality, efficacy, and patient safety.” 

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Topics: Pharmaceutical Microbiology, microbial contamination, QC Labs

OOS Investigations topic of 2014 PharmaLab Congress in Dusseldorf

Posted by Rapid Micro Biosystems

Nov 19, 2014 1:00:00 AM

oos investigations topic PharmaLab Congress in DusseldorfRapid Micro Biosystems is exhibiting the 2014 PharmaLab Congress at the Swissotel hotel in Dusseldorf, Germany. The conference covers topics such as analytics, bioanalytics, microbiology and research and development. Attendees will also be able to get to know companies exhibiting between conference rooms, including Rapid Micro Biosystems at Stand 10.

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Topics: OOS Investigations, automatic rapid microbial detection, RMM

New Technical Document on Bio-Contamination from PHSS

Posted by Rapid Micro Biosystems

Nov 12, 2014 9:00:00 AM

179302756Contamination is a major issue for pharmaceutical manufacturers that want to mitigate risks that might compromise product quality, efficacy and patient safety.

On September 12th, the Pharmaceutical & Healthcare Sciences Society (PHSS) addressed this need by releasing “Technical Document No. 20 – Bio-contamination characterization, control, monitoring and deviation management in controlled/GMP classified areas.”  The document, five years in the making by the U.K.-based nonprofit, is guidance to developing control strategies for modern sterile pharmaceutical manufacturers.

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Topics: microbial contamination, quality control, Sterile Pharmaceutical Manufacturing

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