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Formulation Development
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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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Odin All-in-one Cellular Characterization System
Biolog
Type:
Inquire
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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Companies that sell Microbial Detection Systems
bioMérieux, Inc.
Durham
,
NC
,
United States
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Articles
Odin All-in-one Cellular Characterization System
Microbiology of COVID-19: Chronicle of an Announced Pandemic
Microbial Control Strategy for iNeST mRNA a Cell-Free, Individualized ATMP
Growth Direct® Rapid Sterility System
Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
The Risk of
Bacillus cereus
to Pharmaceutical Manufacturing
Sievers Soleil Rapid Bioburden Analyzer
BacT/ALERT 3D Microbial Detection System
On-Demand Webinar: Parameters for Consideration in the Selection of Particles Used to Calibrate and Assess Online Water Bioburden Analyzer System Performance
VITEK MS MALDI-TOF Mass Spectrometer for Microorganism Identification
Rapid Sterility Testing of Filterable Samples
Technologies for Aseptic Filling: The Choice is Clear
A Risk Assessment Approach to Address Fungal Spore Contamination in a Cell and Gene Therapy Cleanroom and Modern Methods for Control
Sievers Soleil Rapid Bioburden Analyzer
A Fresh Look at USP <1223> Validation of Alternative Microbiological Methods and How the Revised Chapter Compares with PDA TR33 and the Proposed Revision to Ph. Eur. 5.1.6
Sterilizing-Grade Filtration Membrane Bubble Point Requirements During Product Bacteria Challenge Tests Utilized In Process Validation
An Interview With... Giuliana Lescard Of MilliporeSigma
Celerion Offers Molecular and Cell Biology Testing Services with Latest Expansion
An Interview With... Dr. Michael J. Miller, President, Microbiology Consultants, LLC
Bacterial Spore Formers in Disinfectant Efficacy Testing
Continuous & Intervention-Free Microbial Monitoring : Innovation for a Changing Industry
The Need for Speed and Confident Decision Making: Implementing Rapid Micro Methods (RMMs) Throughout Production
Microbial Testing for the Pharmaceutical Industry
Assessment of Techniques to Determine Bacterial Contamination in Water
Improving Microbial Cryopreservation Methods
Regulatory Submissions for Rapid Microbiological Methods (RMMs)
Expectations for Microbial Environmental Monitoring Investigations for Sterile Manufacturing Critical Areas
Novo Nordisk Foundation Partners with CARB-X to Fight Drug-Resistant Infections
Conducting Microbial Investigations
New USP Microbiology Content Will Support Cell and Gene Therapy Manufacturing
ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray Products Recalled
Design And Evaluation of a Disinfectant/Sporicide Combination Triple Sanitization And In-Situ Disinfectant Validation
Improving the Sterility Assurance Section of an Application to Allow for More Efficient Assessment of ANDA and NDA Submissions to the FDA
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Microbiological Attributes of Powdered Cannabis
Instantaneous Microbial Detection: 21st Century Process Control Tool for Pharmaceutical Water Systems
Lack of Utility of the USP Tests for Specified Microorganisms
Eagle Pharmaceuticals Receives FDA Qualified Infectious Disease Product and Fast-Track Designation for a Bacterial Virulence Neutralizer
The Intricacies of Testing for Mycoplasmas in Cell Culture Systems
Article: The Need for Speed and Confident Decision Making - Implementing Rapid Micro Methods (RMMs) Throughout Production
An Interview with Veronika Wills - Manager, Technical Services Associates of Cape Cod, Inc.
New Regulation to Reduce Contamination Risks in Sterile Manufacturing—and Ways to Adapt
Examining Claims Accepted as Fact in LAL and rFC Comparison Studies
Microbiologics Acquires Cryologics
Lasair Pro
On-Demand Webinar: A Straightforward Path Toward Regulatory Compliance and Data Integrity with Your Microbial Testing Systems
White Paper: Successfully Implementing Rapid Microbial Methods for Mycoplasma Detection
Identification of Recovered Environmental Microbial Isolates
The Use of In-House Microbial Isolates in Disinfectant Efficacy Testing: Challenges and Solutions
Parametric Release: A Regulatory Perspective
eBook: TOC and Microbial Detection Monitoring
The Truth of Endotoxin Values - Points for Consideration During Investigation of Aberrant BET Results
Detection of Pyrogens Pyromat 2019008029
White paper: Making the Switch to In-House Mycoplasma Testing
Bacterial Endotoxins Testing in Lipid-Based Drug Formulations Using Liquid-Liquid Extraction
Advances in Microbial Identification and the Microbiome
Mold Monitoring and Control in Pharmaceutical Manufacturing Areas
An interview with Rafael Costa-Vice President of Sales, ACG
Continuous & Intervention-Free Microbial Monitoring: Innovation for a Changing Industry
Multidrug Antimicrobial Resistance Testing and Fecal Transplant Therapy Risks
Our Complicated Relationship with Fungi
MBio Delivers Rapid Cytokine Test System for COVID-19 Research
Effectivity of HEPA Filters to Remove Viruses from Air Entering Cleanrooms
Functional Challenges for Alternative Bacterial Endotoxins Tests Part 2: Comparability
AbbVie Launches Collaboration with HotSpot Therapeutics to Expand Immunology Pipeline
Rapid Detection of
Escherichia coli
by Real-Time PCR in Pharmaceutical Products Contaminated by Low Levels of
Bacillus megaterium, Burkholderia cepacia, Escherichia coli,
and
Staphylococcus aureus
The Monocyte Activation Test: Moving Away from Animal-Based Tests for Pyrogen Detection
Data Integrity and Rapid Micro Methods: Transforming to a Modern Microbiology Lab
Impact of Data Integrity Audits on Pharma Microbial QC Labs
Codex DNA Releases Synthetic Genomes for Emerging SARS-CoV-2 Variants
Microbiological Data Integrity: Points to Consider Regarding Second Analyst Verification
Endotoxin Detection: The Four Pillars of rFC Adoption in Lieu of LAL
The Importance of Not Being Too Attached: Pharmaceutical Equipment Characteristics and Microbial Attachment
Nelson Labs Announces Pharmaceutical Center of Excellence to Serve Parenteral and Ophthalmic Drug Product Manufacturers
Functional Challenges for Alternative Bacterial Endotoxins Tests Part 1: Attributes for Alternative Tests
eBook: Lipid Technologies: Helping to Develop the Next Generation of Pharmaceuticals
Assessing Microbial Contamination: Best Practices for Pharmaceutical Microbial Data Investigations
QC Corner: How the 2020 draft EU GMP Annex 1 changes will affect sterile pharmaceuticals manufacturing in North America
Landmark Bio Unveils New State-of-the-Art Full-Spectrum Biomanufacturing Innovation Center
Comments on Aseptic Process Simulation (APS) in the New EU GMP Annex 1
Formulation and Lyophilization Process Development for Endotoxin Kits
European Pharmacopoeia Approach to Testing for Pyrogenicity
Biologics Production: Impact of Bioburden Contaminations of Non-Sterile Process Intermediates on Patient Safety and Product Quality
QC Corner: Neutralizers to avoid false negatives in microbial monitoring
Helix Receives Expanded EUA for Helix® COVID-19 Test
FDA Authorizes Antigen Test as First OTC At-Home COVID-19 Diagnostic Test
Mycoplasma Testing in an Ever-Changing World
Kantaro Receives EUA for Semi-Quantitative COVID-19 Antibody Test Kit
Modern Perspectives on LAL Non-Endotoxin Reactivity
FDA Authorizes BinaxNOW COVID-19 Ag Card Home Test
Inspectional Readiness for Aseptic Cleanroom Operations
Sartorius Stedim Biotech Launches ambr® 15 Cell Culture Microbioreactor System
The Value and Benefits of Rapid Mold Detection in the Pharmaceutical Industry
Data Integrity in the QC Lab – Reducing the Potential for Human Error in Endotoxin Testing
Improving Process and Data Integrity Using Rapid Microbial Methods
Optimizing and Future-Proofing Bacterial Endotoxin Testing with Flexible Automation
Process Validation and Sterility Assurance: Relations and Requirements
Minimizing Microbial Survival of Cleanroom Surfaces
LAL and rFC Comparison Study Caveats
How to Use a Risk-Based Scientific Approach to Qualify Replenishment Working Cell Banks
4.2% Sodium Bicarbonate Injection and 1% and 2% Lidocaine HCl Injection Recalled
The Evaluation of a Ready-to-Use Combination Sanitization Regimen to Support a Contamination Control Strategy
Facility Tour: Microbiologics - Expanding Infectious Disease Testing
Asahi Kasei Bioprocess and Axolabs Announce Strategic Partnership to Accelerate Oligonucleotide Therapeutics Development
Today's COVID-19 News: December 11, 2020
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On-Demand Webinar: Rapid Sterility Testing as the Critical and Final Result for Product Release
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