The Rapid Blog & News

Eliminating Dilutions Through Enhanced Dynamic Range and Linearity

Posted by Rapid Micro Biosystems

Apr 17, 2014 7:00:00 AM

eliminating-dilutionsDilution can be a time-consuming and error-prone component of microbiological testing, but it is critical. While some sample types inherently provide technicians with the microbial concentrations they'll need, many must be diluted before they can be incubated and accurately counted. Given the typical sizes of petri dishes, it is generally accepted that most microbiologists can accurately count roughly 100 CFUs per plate, while 300 CFUs is seen as the upper limit for detection by the naked eye.

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Topics: Rapid Enumeration, Rapid Micro Biosystems, The Growth Direct System, microbial testing, RMM, dilution

Imaging Technology: How Microbiologists Benefit from a Larger Dynamic Range

Posted by Rapid Micro Biosystems

Apr 15, 2014 7:00:00 AM

how-microbiologists-benefitIn addition to rapid results, growth-based RMM technology provides a key benefit for microbiologists seeking more accurate and reliable colony counts: a far larger dynamic range. When using the compendial method, most quality control labs dilute their samples to achieve colony counts of 100 or fewer, with 300 being the standard upper range for manual detection. Even at those numbers, however, overgrown colonies of different sizes can make it extremely difficult for technicians to achieve consistent counts.

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Topics: Rapid Micro Biosystems, The Growth Direct System, automated enumeration, RMM

Working with Unusual Sample Types: Taking Advantage of RMM Technologies

Posted by Rapid Micro Biosystems

Apr 9, 2014 9:30:00 AM

rmm-technologyEven when using the time-tested traditional method for colony enumeration, microbiologists often run into difficulties when working with unusual samples. Creams and cosmetic products, for example, are often hard-to-filter and cell cultures and tissue samples contain filter-clogging materials.

There are many ways for quality control personnel to filter out the materials in these samples, allowing them to efficiently run traditional filtration tests. Previously, we covered the following fixes:

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Topics: Rapid Micro Biosystems, The Growth Direct System, microbial testing, RMM

Working with Unusual Sample Types: Breaking Down Organic Materials

Posted by Rapid Micro Biosystems

Apr 7, 2014 10:00:00 AM

cell-culture-testingMicrobiologists often have to contend with cumbersome materials for bioburden and sterility tests. Most products must be diluted and filtered to allow for effective and efficient testing. Many pharmaceutical products contain materials that are difficult to break down and pass through a standard 0.45 micro filter.

Still, there are techniques available for quality control workers prepare samples that could not be traditionally filtered. In the last installment of this series, we discussed a few fixes for solubilizing the materials in capsules, creams and particulates. This time, we'll cover a few techniques to prepare sample such as mammalian cell culture and tissue samples for filtration. By using filtration, larger sample sizes of these materials can be tested than possible using other methods such as spread plating, improving accuracy and lowering limit of detection for contaminants. In addition, filtration opens the door to taking advantage of a wider variety of automated growth-based rapid micro methods.

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Topics: Rapid Micro Biosystems, automated enumeration, microbial testing, RMM, bioburden and sterility tests

Amy McDaniel to Present Poster at PDA Annual Meeting

Posted by Rapid Micro Biosystems

Apr 4, 2014 9:30:00 AM

global-changeOn April 7th and 8th, Amy McDaniel, Associate Director, Production Operations, Pfizer, will be presenting a scientific poster at the 2014 PDA Annual Meeting in San Antonio.  This year’s theme is, “Biopharmaceutical and Sterile Pharmaceutical Manufacturing – Embracing Innovation to Meet Global Challenges,” and the program will include updates and sessions from regulators, practitioners and industry experts.

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Topics: Amy McDaniel, pda annual meeting, Sterile Pharmaceutical Manufacturing, Pfizer

Working with Unusual Sample Types: Solubilizing Large Particulates

Posted by Rapid Micro Biosystems

Apr 3, 2014 10:22:00 AM

solubilizing-capsule-filtrationWhile it is often preferable to use filtration to test samples in pharmaceutical manufacturing, samples that contain fillers, dyes, living tissues and other particulates are difficult or impossible to filter with normal procedures. Examples are products like capsules or gels, which can be difficult or are perceived to be impossible to test with filtration.

There are options microbiologists can explore to filter unusual sample types through industry standard 0.45 micron filters. In the first installment of this series, we'll discuss common solutions for dealing with capsules, creams and papers.

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Topics: Automation, Rapid Micro Biosystems, microbial testing, filtration

5 Considerations for Selecting an RMM System

Posted by Rapid Micro Biosystems

Mar 20, 2014 7:00:00 AM

quality-control-labAs the pharmaceutical industry continues to embrace lean principles in the quality control lab, companies are beginning to explore a variety of rapid microbiological methods (RMM) that streamline or replace the manual method for microbial testing. These systems vary in their method and technology. Quality Control managers must do their due diligence before determining the best fit for their lab. The following are five important factors for QC managers to consider as they build their case for an RMM system:

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Topics: Non-destructive Microbial Enumeration, Rapid Micro Biosystems, RMM

The Efficiency of a Single, Non-Destructive RMM System in the Quality Control Lab

Posted by Rapid Micro Biosystems

Mar 18, 2014 7:00:00 AM

RMM-QC-LabWith automated, non-destructive, growth-based rapid microbiological methods (RMM), microbiologists can cut costs, reallocate labor and streamline repetitive processes within their labs. Technologies such as The Growth DirectTM System allow labs to replace the traditional method for major microbiological tests such as water, bioburden, environmental monitoring and sterility testing.

These capabilities not only help microbiologists to efficiently replace the manual method for counting colonies; they allow labs to optimize their limited time and resources by using single method with a single set of requirements for training, many that mimic the existing preparation steps. The following are a just a few of the ways QC labs can maximize efficiency through the use of a single, non-destructive RMM system:

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Topics: Rapid Micro Biosystems, The Growth Direct System, automated rapid enumeration, RMM

Don’t Miss Our RMM Validation Webinar March 25

Posted by Rapid Micro Biosystems

Mar 13, 2014 8:00:00 AM

checkmark-1On Tuesday, March 25, at 11a.m. EDT, Rapid Micro Biosystems will present the live webinar, “Validating an Automated Rapid Method: Determining Time to Results.” Led by Dr. Andrew Sage, manager of microbiology applications, the webinar will help participants understand the ins and outs of growth-based rapid microbial method validation.

Points of interest will include:

Multi-Point Readings

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Topics: webinar, Rapid Micro Biosystems, RMM

Accelerating Biological Indicator Testing with The Growth Direct™ System

Posted by Rapid Micro Biosystems

Mar 11, 2014 9:00:00 AM

biological-indicator-testingWith the aid of growth-based rapid microbiological methods (RMM) technologies, pharmaceutical quality control departments are able to speed up their bioburden, environmental monitoring and sterility testing, while also achieving greater accuracy and reliability compared to the compendial methods. Through the application of sophisticated imaging equipment, automated sample handling and immediate reporting, microbiologists can now perform high-volume testing while at the same time reducing labor and improving time to results.

Additionally, RMM technologies can streamline applications beyond environmental monitoring, sterility and bioburden testing. Take biological indicator (BI) testing, for instance, a critical step in the qualification of sterilization processes. Biological indicators are standardized preparations of microorganisms with known resistances to sterilization processes such as steam, dry heat and radiation. The basic BI types include:

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Topics: Rapid Micro Biosystems, The Growth Direct System, microbial testing, RMM

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