The Rapid Blog & News

Rapid, Automated Environmental Monitoring on the Manufacturing Floor

Posted by Rapid Micro Biosystems

Sep 16, 2014 7:30:00 AM

environmental_monitoring_manufacturing_floorEnvironmental monitoring (EM) is an important part of ensuring product quality in pharmaceutical manufacturing. For large companies with vast, campus facilities, however, it can also be one of the most time-consuming. Microbiologists often spend hours a day travelling from the microbiology QC lab to production lines, gowning in and capturing samples, then travelling back to the lab to begin incubation. The travel ads complexity to the process and presents additional opportunities for mishandling or lost samples.

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Topics: Environmental Monitoring, quality control

Don’t Miss Rapid Micro Biosystems on the Seminar Circuit this Fall

Posted by Rapid Micro Biosystems

Sep 11, 2014 7:30:00 AM

Rapid_Micro__Biosystems_Upcoming_SeminarsLooking to learn more about the far-reaching benefits of automated, rapid microbial detection and enumeration? Our resources section is a great place to start, but you won't want to miss your chance to talk to our experts first hand during our presentations on the web and around the globe.

Here's where we'll be over the next couple of months:

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Topics: Rapid Micro Biosystems, rapid microbial enumeration, rapid microbial detection

6 Strategies for Communicating Quality Control Data

Posted by Rapid Micro Biosystems

Sep 9, 2014 2:00:00 PM

communicating_quality_control_dataRapid Micro Biosystems has had the opportunity to speak with industry experts on a variety of topics of particular interest the QC microbiology lab.  In the next part of this series, we discuss communicating results to the rest of the organization.

Aside from the manual, repetitive work involved in microbiological testing, one of the most time-consuming and often frustrating aspects of the quality control process is communicating data to other departments and stakeholders. Supervisors and investigators need access to out-of-specification results, manufacturing personnel need to know when products have been approved for shipment, and some executives may even want to observe trends in problem areas and cleaning procedures themselves.

Automated rapid methods that integrate to LIMS can remove almost all the manual data entry associated with testing.  Even at companies that use laboratory information systems (LIMS) or other electronic record-keeping systems, the inefficient use of those technologies can actually increase overall workloads.The following are six strategies that successful companies have found make data dissemination an easier, more efficient process.

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Topics: LIMS, automatic rapid microbial detection, quality control

How to Perform Faster, Effective Out-of Specification Investigations

Posted by Rapid Micro Biosystems

Sep 4, 2014 9:30:00 AM

qc-lab-oos-investigationsRapid Micro Biosystems has had the opportunity to speak with industry experts on a variety of topics of particular interest to the QC microbiology lab.  In the next few posts we’ll be sharing their insight and thoughts on these topics. The first of these concerns is out of specification Investigations.

Even the most well run and efficient pharmaceutical manufacturers will have Out-Of-Specification (OOS) investigations, and, for some manufacturers, the costs of these can reach the hundreds of thousands per year. While some OOS investigations uncover training and handling issues, the possibilities of in-lab and in-process contamination require quality control personnel to perform their due diligence every time a sample indicates an unacceptable level of microbial growth.

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Topics: OOS Investigations, QC Labs

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 Direct™ 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

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