The Rapid Blog & News

Fungal Contamination: 3 Commonly Overlooked Issues

Posted by Rapid Micro Biosystems

Sep 2, 2014 7:30:00 AM

fungal_contaminations_QC_labsFor pharmaceutical manufacturers, contamination is an obvious cause for concern. Fungal contamination, specifically, poses greater hazards to manufacturing clean areas than some manufacturers may realize. As such, opportunities exist to better address fungal contamination. In fact, Dr. Tim Sandle, head of microbiology at Bio Products Laboratory, recently wrote an article on the subject entitled, “Fungal Contamination of  Pharmaceutical Products: A Growing Menace”, where he notes that, “Contamination risk posed by fungi to pharmaceutical products is greater than the level of industrial and academic interest would suggest.”

As part of the article, Dr. Sandle highlights some of the most commonly overlooked considerations related to fungal contaminations in QC labs:

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Topics: rapid microbial testing, QC Labs, fungal contamination

Time Management: 3 Time Consuming Activities in the QC Lab

Posted by Rapid Micro Biosystems

Aug 28, 2014 7:30:00 AM

time_management_qc_labBeing a microbiologist in a quality control (QC) lab can be both challenging and rewarding. You’re accountable for multiple activities that contribute to ensuring the quality of products being manufactured and delivered to end customers. You have your hands on multiple events of the lab—so time management can be critical. 

The following are some key activities that take time in the lab that could be handled by an automated, rapid technology such as the Growth DirectTM System. 

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Topics: RMM, QC Labs, time management

3 Benefits of Automation in the QC Lab You May Not Have Considered Yet

Posted by Rapid Micro Biosystems

Aug 26, 2014 7:30:00 AM

efficiency_qc_labThe evolution of technology available in pharmaceutical manufacturing has progressed over the years. Specifically, advancements in automation within quality control (QC) laboratories have played a major role in improving the microbial testing process. 

With the traditional testing method, QC labs are forced to perform time consuming tasks, including manual incubation transfers and interim counts. During this time, events like product quarantines, delayed production and/or waiting for certain components to pass inspection can potentially have hefty financial costs. 

However, with equipment that utilizes automated rapid microbial methods (RMM), value in various areas of a QC lab can be realized, many of which overlap or influence one another. 

You’ve probably heard of some obvious benefits of automation, including fewer incubation transfer errors, integration with LIMS and rapid results. But there are several more benefits of automation that aren’t as obvious, including: 

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Topics: The Growth Direct System, RMM, Benefits of Automation

Faster Bioburden Enumeration of Fiber Wipes using Growth Directâ„¢ System

Posted by Rapid Micro Biosystems

Aug 21, 2014 7:30:00 AM

growth_direct_system_time_savingsHow can you accurately and quickly determine the bioburden in samples that contain solid, insoluble materials? Can rapid methods be applied to samples that may contain particulates that disrupt the detection of microbial contaminants? In April's blog, “Working with Unusual Sample Types: Solubilizing Large Particulates,” we addressed these questions and covered a few strategies for removing particles from capsules, gels and creams. Today, we'll discuss similar techniques for the preparation of fiber wipe samples, as well as the advantages of automated, growth-based rapid microbial methods (RMM) in testing those samples.

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Topics: The Growth Direct System, RMM, Bioburden Enumeration, fiber wipes

Preparing for a Validation: Some Best Practices

Posted by Rapid Micro Biosystems

Aug 5, 2014 7:30:00 AM

validation_RMM_practicesFor pharmaceutical manufacturers, validation is one of the most involved aspects of the implementation of rapid microbial methods (RMM). Validation of a new method involves not only external regulatory authorities, but internal quality assurance and other stakeholders.

While the validation process will be time consuming, it can be a smooth process, particularly when implementing methods that would be considered “automated compendial,” such as the Growth DirectTM System. This system simply automates the traditional assay. Preparation can also make the validation process as efficient and streamlined as possible.  In addition, the provider of the rapid method may have some of the resources and documentation already available for use. 

The following are a few best practices from companies currently navigating or completing their validation processes:

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Topics: Validation, RMM

Real-World Use Cases of Automated, Growth-Based RMM: Moving Toward a Paperless QC Lab

Posted by Rapid Micro Biosystems

Jul 31, 2014 7:30:00 AM

Paperless_QC_LabAutomated, growth-based rapid microbial methods (RMM) are designed to reduce the time, resources and errors potentially caused by the manual method for microbial enumeration. Pharmaceutical manufacturers worldwide are beginning to use RMM in their labs to streamline quality control (QC) workflows. However, improving upon the compendial method isn't the only advantage of RMM. Some RMM technology offers ancillary benefits that can be just as useful for companies with unique needs and goals.

For instance, certain technologies such as the Growth DirectTM System provide automation and network integration to LIMS, two features that deliver additional advantages for QC personnel and other stakeholders. QC labs and their technologies have traditionally been somewhat disconnected from their company’s LIMS system, relying on manual keying of data and paper documentation. By automating enumeration and reporting and reducing paper use, manufacturers can not only hasten their microbial testing and achieve more reliable results—they can also make better use of their personnel and material resources.

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Topics: Rapid Micro Methods, The Growth Direct System, RMM, paperless qc lab

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

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