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Real-World Use Cases of Automated, Growth-Based RMM: Implementing Company-Wide RMM Validation Standards

Posted by Rapid Micro Biosystems

Jul 29, 2014 7:30:00 AM

microbesAs the pharmaceutical industry embraces lean initiatives in quality control (QC), labs are finding the validation of new processes and techniques to be one of the most involved tasks in implementing new methods. The implementation of rapid microbial methods (RMM) requires validation that the new method is equivalent to the current traditional test. 

For large manufacturers, RMM validation can seem overwhelming at first, particularly when processes can vary from one facility to the next. However, the similarity between automated, growth-based RMM and the compendial method makes validation a more straightforward process compared to the validation of alternative methods. By creating company-wide implementation standards, even the largest manufacturers can streamline this process as they install automated, growth-based technologies throughout their different facilities.

Thus far we've discussed RMM use cases in streamlining microbial testing, better utilizing resources, and accelerating the cleanup process between small batch runs. Today we'll cover a few best practices in establishing company-wide standards for the implementation of automated, growth-based RMM.

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Topics: Validation, Rapid Micro Methods, RMM

Rapid Microbial Methods: A Q&A with Dr. Tim Sandle

Posted by Rapid Micro Biosystems

Jul 24, 2014 7:30:00 AM

Tim_(profile)Rapid microbial methods (RMM) have become a prevalent topic in microbiology quality control (QC)—particularly among QC labs with lean or paperless initiatives. However, RMM is not necessarily a one-size-fits-all proposition for every facility or process. Furthermore, in highly regulated industries such as pharmaceutical manufacturing, it can be difficult to sway the industry away from the tried and true traditional method. 

Rapid Micro Biosystems recently had the opportunity to speak with Dr. Tim Sandle, head of microbiology at Bio Products Laboratory, regarding his perspective on RMM and the pharmaceutical manufacturing industry in general. 

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Topics: RMM, QC Labs, Rapid Microbial Methods, Dr. Tim Sandle

Applying Lean in the QC Lab Part 3: Benefits of Automation

Posted by Rapid Micro Biosystems

Jul 22, 2014 7:30:00 AM

lean_benefits_automationIn our first two editions of “Going Lean in the QC Lab,” we discussed the principles of lean initiatives and different types of waste that lean initiatives help to identify. As you have started to look at your processes, you have likely seen areas where simple improvements can have significant gains. 

For many companies, adoption of lean principles means process improvements. Process improvements can be enhanced with the strategic use of automation. Here, we will cover how automation can be applied to a lean initiative.  

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Topics: Automation, Lean Lab, QC Labs

Applying Lean in the QC Lab Part 2: Identifying Types of Waste

Posted by Rapid Micro Biosystems

Jul 17, 2014 7:30:00 AM

identifying_waste_fasterIn the first part of our series on applying lean in the quality control (QC) lab, we discussed the key principles of lean manufacturing. Today, we’ll discuss the steps to identify waste that exist in the current process.  These are the areas that typically provide the most opportunity to save time and resources.

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Topics: Lean Lab, Lean Manufacturing, QC Labs

Applying Lean in the QC Lab Part 1: Main Principles

Posted by Rapid Micro Biosystems

Jul 15, 2014 7:30:00 AM

lean_main_principlesThe concept of lean manufacturing isn’t new. For decades, manufacturers have implemented lean programs into their processes and many have reaped the benefits of more efficient processes with less waste. Like all manufacturers, the pharmaceutical industry has embraced the principles of lean. In recent years, it has become clear that areas beyond manufacturing, such as laboratory quality control (QC), can benefit from the application of lean. Since the very goal behind being lean is to eliminate waste, minimize error and drive quicker, more impactful end results, it’s not hard to see the benefits. 

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Topics: Lean Lab, quality control process, quality control, QC Labs

Getting to Know Growth Direct™ System

Posted by Rapid Micro Biosystems

Jul 10, 2014 7:30:00 AM

getting_to_know_growth_direct_systemMicrobial quality control (QC) testing has made strides over the last several years. And as technologies such as the Growth DirectTM System advance, the easier it becomes to quantify and justify the economic benefits. The automated system, which utilizes rapid microbial methods (RMM), analyzes user-prepared samples—just as the traditional method would—and is designed to optimize microbial test performance and ease of use. 

Get to know the Growth DirectTM System. Check out our video or check out the information below. In less than five minutes, you’ll understand the difference one investment in rapid automation can make for your QC efforts. 

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Topics: Rapid Micro Methods, The Growth Direct System, RMM

Automating Environmental Monitoring: Your Top Questions Answered

Posted by Rapid Micro Biosystems

Jul 8, 2014 7:30:00 AM

environmental_monitoring_questions_Environmental monitoring is likely just one of many microbial tests you perform on a daily basis. It’s also likely that your quality control (QC) laboratory still uses the compendial method to conduct these tests. And though the method is time-tested, you know all too well it’s time consuming and prone to manual error.

The micro QC lab is being asked to do more and more with fewer resources.  It’s becoming increasingly important to find ways to increase efficiencies in the lab, such as leveraging lean initiatives. This is where automated rapid microbial methods (RMM) for quality control (QC) testing can be valuable. Designed to improve efficiency, RMMs can deliver the results QC labs are required to provide—in less time. 

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Topics: Rapid Micro Methods, Environmental Monitoring, The Growth Direct System, RMM

Automation: Your Top Water and Bioburden Testing Questions Answered

Posted by Rapid Micro Biosystems

Jul 3, 2014 7:30:00 AM

water_bioburden_testingIn the last edition of the frequently-asked-questions series, we discussed some of the top questions Rapid Micro Biosystems receives regarding our Growth DirectTM System. However, with sophisticated technologies such as those utilizing the rapid microbial method (RMM), there are always additional questions to address—especially when you need to build a business case for purchasing such a system. 

Like any industry, in order to thrive in an increasingly competitive economy, quantifying the benefits of products and solutions is becoming more vital. For microbiologists specifically, being able to achieve maximum efficiency by streamlining testing procedures puts you well on your way to demonstrating the value of RMM. 

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Topics: Rapid Micro Methods, The Growth Direct System, RMM, bioburden and sterility tests

Growth Direct™ System: Your Top Questions Answered

Posted by Rapid Micro Biosystems

Jul 1, 2014 7:30:00 AM

growth_direct_system_questionsIf you work in microbial quality control (QC) for your company, performing tests including water, bioburden, sterility and environmental monitoring,  you don’t have to be told these tests are time consuming and not always the most efficient use of your skills. Yet, for most pharmaceutical manufacturers, it is still the standard process for QC laboratories.

As the speed of business increases, time becomes money for everyone. That’s why is it crucial to invest in technologies that are effective and efficient. 

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Topics: Rapid Micro Methods, The Growth Direct System, RMM

Real-World Use Cases of Automated, Growth-Based RMM: Streamlining Small Batch Runs

Posted by Rapid Micro Biosystems

Jun 26, 2014 7:30:00 AM

RMM_Streamlining_Small_Batch_RunsThe pharmaceutical industry is embracing lean initiatives in quality control (QC), and along with the process improvements being implemented, forward-thinking businesses are looking to complement the process with the rapid microbial methods (RMM). Among the most versatile of these technologies is automated, growth-based RMM, a method that automates and accelerates the compendial method for microbial enumeration.

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Topics: The Growth Direct System, automated enumeration, RMM, quality control

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