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Excipients
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Pharmaceutical Microbiology
Microbial Detection Systems
Microbial Detection Systems
An analysis of FDA product recall data for 134 non-sterile pharmaceutical products from 1998 to 2006 showed that 48% of recalls were due to contamination by the bacteria Burkholderia cepacia, Pseudomonas spp., or Ralstonia picketti, while yeast and mold contamination were found in 23% of recalls.
Microbial Detection Systems perform an important role in assuring pharmaceutical products are free from unwanted bacteria, yeast, mold and other microbial contaminants before leaving the manufacturing facility. Recently, rapid and automated microbial detections systems have been developed to speed the detection process.
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Sponsored Products
Odin All-in-one Cellular Characterization System
Biolog
Type:
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Pharmaceutical Application:
Phage therapy, drug discovery, basic research, pharmaceutical research, environmental monitoring, quality control, fermentation, bioprocessing, cellular characterization, microbiome research
Temperature Range:
22 to 45° C
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7000RMS Real-Time Microbial Detection Analyzer
Mettler Toledo
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Temperature Range:
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Growth Direct® Rapid Sterility Application
Rapid Micro Biosystems, Inc
Type:
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Sievers Soleil Rapid Bioburden Analyzer
Veolia Water Technologies & Solutions - Analytical Instruments
Type:
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Pharmaceutical Application:
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Temperature Range:
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BacT/ALERT® 3D Microbial Detection System
bioMérieux, Inc.
Type:
Automated microbial detection system
Pharmaceutical Application:
Microbial testing
Temperature Range:
[RT + 5C] to 45C
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DiversiLab Microbial Detection System
bioMérieux, Inc.
Type:
DNA fingerprinting and analysis (Bacterial strain typing)
Pharmaceutical Application:
Sterility Testing, Strain Typing, Root cause investigation
Temperature Range:
5 to 40C
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PREVI Color Gram Automated Gram Staining System
bioMérieux, Inc.
Type:
Gram Staining
Pharmaceutical Application:
Pre-analytical microbiology automation, Automated gram staining, Reduced waste, Improved efficiency, Workflow and standardization
Temperature Range:
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VITEK 2 Compact Bacterial Identification and Monitoring System
bioMérieux, Inc.
Type:
QC laboratory testing
Pharmaceutical Application:
Bacterial identification and monitoring, Quality assurance testing, Data management with Observation
Temperature Range:
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VITEK MS MALDI-TOF Mass Spectrometer for Microorganism Identification
bioMérieux, Inc.
Type:
MALDI-TOF MS
Pharmaceutical Application:
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Temperature Range:
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Axcess System® Biochemical Identification System
Charles River
Type:
MALDI-TOF Technology
Pharmaceutical Application:
Microbial identification
Temperature Range:
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Celsis Accel® Rapid Microbial Detection System
Charles River
Type:
Rapid microbial detection through Amplified-ATP bioluminescence
Pharmaceutical Application:
QC Microbial testing for USP <61>, in process bioburden and sterility testing USP <71>.71>61>
Temperature Range:
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Celsis Advance II™ High-Throughput Rapid Microbial Detection System
Charles River
Type:
Rapid microbial detection through Amplified-ATP bioluminescence
Pharmaceutical Application:
QC Microbial testing for USP <61>, in process bioburden and sterility testing USP <71>.71>61>
Temperature Range:
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Milliflex Quantum Rapid Detection System
MilliporeSigma
Type:
Fluorescent Staining-based System
Pharmaceutical Application:
Raw material (media, buffers, pharmaceutical ingredients and water), In-process samples (bioburden prior to sterilization, CIP/SIP samples, cell culture/fermentation samples, media for fermentation, buffers for manufacturing, and intermediate process samples), Final product, Environmental samples
Temperature Range:
15 – 40C (59F - 104F)
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Milliflex® Quantum system
MilliporeSigma
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CellCelector Flex
Sartorius Lab Instruments GmbH & Co.KG
Type:
Cell Selection and Retrieval Instruments
Pharmaceutical Application:
Drug Discovery
Temperature Range:
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CellCelector Flex - Capillaries and Tips
Sartorius Lab Instruments GmbH & Co.KG
Type:
Cell Selection and Retrieval Instruments
Pharmaceutical Application:
Drug Discovery
Temperature Range:
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CellCelector Flex - Nanowell Arrays
Sartorius Lab Instruments GmbH & Co.KG
Type:
Cell Selection and Retrieval Instruments
Pharmaceutical Application:
Drug Discovery
Temperature Range:
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Incucyte
®
S3 Live-Cell Analysis System
Sartorius Lab Instruments GmbH & Co.KG
Type:
Live-Cell Imaging and Analysis System
Pharmaceutical Application:
Drug Discovery
Temperature Range:
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Incucyte
®
SX1 Live-Cell Analysis System
Sartorius Lab Instruments GmbH & Co.KG
Type:
Live-Cell Imaging and Analysis System
Pharmaceutical Application:
Drug Discovery
Temperature Range:
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Incucyte
®
SX5 Live-Cell Analysis System
Sartorius Lab Instruments GmbH & Co.KG
Type:
Live-Cell Imaging and Analysis System
Pharmaceutical Application:
Drug Discovery
Temperature Range:
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iQue Forecyt
®
software
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
Drug Discovery
Temperature Range:
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iQue QBeads
®
PlexScreen
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
Drug Discovery
Temperature Range:
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iQue
®
21 CFR Part 11 Software Module
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
Drug Discovery
Temperature Range:
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iQue
®
3 Flow Cytometry Platform
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
Drug Discovery
Temperature Range:
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iQue
®
Human IgG Titer and Viability Kit
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
Drug Discovery
Temperature Range:
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Microsart
®
ATMP Bacteria/Fungi & ATMP Sterile Release
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
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Temperature Range:
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Sterisart
®
Family Consumables for Sterility Testing
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
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Temperature Range:
Max operating temperature; 50°C
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OpenPlex Flexible Surface Plasmon Resonance Imaging System
Horiba
Type:
Surface Plasmon Resonance
Pharmaceutical Application:
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Temperature Range:
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Octet
®
Bio-Layer Interferometry (BLI) Systems
Sartorius Lab Instruments GmbH & Co.KG
Type:
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Pharmaceutical Application:
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Companies that sell Microbial Detection Systems
bioMérieux, Inc.
Durham
,
NC
,
United States
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Microbial Control Strategy for iNeST mRNA a Cell-Free, Individualized ATMP
Microbiology of COVID-19: Chronicle of an Announced Pandemic
Odin All-in-one Cellular Characterization System
BacT/ALERT 3D Microbial Detection System
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The Risk of
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Rapid Micro Biosystems Secures $25 Million in Series C Equity Financing
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ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray Products Recalled
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Microbial Testing for the Pharmaceutical Industry
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Continuous & Intervention-Free Microbial Monitoring : Innovation for a Changing Industry
Samsung Biologics Selects Rapid Micro Biosystems’ Growth Direct Platform to Automate Critical Microbiology Quality Control Testing
Novo Nordisk Foundation Partners with CARB-X to Fight Drug-Resistant Infections
New Regulation to Reduce Contamination Risks in Sterile Manufacturing—and Ways to Adapt
Parametric Release: A Regulatory Perspective
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Microbiologics Acquires Cryologics
The Use of In-House Microbial Isolates in Disinfectant Efficacy Testing: Challenges and Solutions
Identification of Recovered Environmental Microbial Isolates
White Paper: Successfully Implementing Rapid Microbial Methods for Mycoplasma Detection
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Advances in Microbial Identification and the Microbiome
Codex DNA Releases Synthetic Genomes for Emerging SARS-CoV-2 Variants
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eBook: TOC and Microbial Detection Monitoring
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The Truth of Endotoxin Values - Points for Consideration During Investigation of Aberrant BET Results
Detection of Pyrogens Pyromat 2019008029
Endotoxin Detection: The Four Pillars of rFC Adoption in Lieu of LAL
White paper: Making the Switch to In-House Mycoplasma Testing
AbbVie Launches Collaboration with HotSpot Therapeutics to Expand Immunology Pipeline
Bacterial Endotoxins Testing in Lipid-Based Drug Formulations Using Liquid-Liquid Extraction
Impact of Data Integrity Audits on Pharma Microbial QC Labs
An interview with Rafael Costa-Vice President of Sales, ACG
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