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Publications

Your source for informative whitepapers, posters, articles, and other publications from Rapid Micro Biosystems.

eBook

Principles of Bioburden Testing

September 2024

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Infographic

Ease your Burden in Bioburden Testing

September 2024

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Article

EJPPS: An Alternative Medium to Support Sterility Testing Using the Growth Direct® Rapid Sterility System

July 2024

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Poster

Rapid Sterility Testing as the Critical and Final Result for Product Release – Design Verification (DV) Data

May 2024

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Article

Making Automation the Standard: An Annex 1 Overview

November 2023

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Whitepaper

MAS-100 NT Air Sampler Evaluation with Growth Direct® Media Cassettes

October 2023

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Poster

The Impact of Plate Size on Passive Air Monitoring

October 2023

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Poster

Case Studies Applying Enhanced Automation and Rapid Detection of Mold from Bacteria

October 2023

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Poster

To Stress, or Not to Stress

October 2023

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Poster

Preservative Efficacy Testing Through the Growth Direct® System

August 2023

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WHITEPAPER

The Value and Benefits of Rapid Mold Detection in the Pharmaceutical Industry

July 2023

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ARTICLE

Validation of the Imaging Technology for a Novel Microbiological Colony Counter

April 2023

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Article

Why Mold Detection Method Matters

March 2023

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Article

PDA JPST: Multisite Qualification of an Automated Incubator and Colony Counter for Environmental and Bioburden Applications in Pharmaceutical Microbiology

November 2022

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Poster

Design Requirements for 21 CFR 11 Compliance and Manufacture 4.0 Readiness in a QC Micro Instrument

October 2022

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Poster

Automated Optical Differentiation of Mold from Non-Mold During Enumeration of EM Test Plates

October 2022

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Article - Q&A

Your Journey to Digital Transformation

September 2022

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Presentation

Annex 1: Potential Changes and Impacts on Microbial QC Automation

September 2022

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Innovation

A Modern View of QC Automation

July 2022

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Article

Proposed Impact of USP Ch <1117>

May 2022

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Article

Kham Nguyen on Pharma 4.0, LIMS Integration, and System Validation

May 2022

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Whitepaper

LIMS Integration: Overcoming the Hurdle of Microbial QC Digitalization

May 2022

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Tech Sheet

Designing the High Performing QC Lab: An Automation Checklist

March 2022

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Tech Sheet

Is Your Quality Control Laboratory Rapid Ready?

March 2022

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Whitepaper

Making Quality Your Competitive Edge

January 2022

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Poster

Determination and Comparison of Time-to-Results Across Global Sites for EM Media via RMM

October 2021

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Whitepaper

SAS Super 180 Air Sampler Evaluation with Growth Direct® Media Cassettes

August 2021

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Whitepaper

Adapting QC Microbiology Labs for the Demands of Cell & Gene Therapies

August 2021

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Video

New Video Shows How Simple It Is to Prevent Human Error in the QC Lab

August 2021

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Video

Rapid Micro Biosystems Sponsors American Pharma Review's Clean Facility of the Future Documentary

August 2021

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Podcast

Maintaining Operational Efficiencies in Micro Labs During a Pandemic

August 2021

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Whitepaper

Planning the QC Micro Lab of the Future: Preparing for Tomorrow's Challenges Today

August 2021

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Whitepaper

Designing the High Performing QC Lab: Performance Questionnaire

August 2021

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Video

Biogen's Implementation of the Growth Direct® System: Driving for Greater Accuracy, Speed, and Efficiency in Microbial Enumeration Poster

August 2021

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Poster

Primary Validation for an Automated Colony Counter per EP 9.2, 5.1.6

July 2021

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Poster

CGMP Data Integrity Using PDA TR80 and ALCOA ALCOA+ Infographic

July 2020

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Poster

MicroWorks Consulting–Comparison of the Growth Direct™ Environmental Monitoring Cassettes to the Conventional Media for Environmental Monitoring

July 2020

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Poster

GSK Rockville–The Growth Direct™ System

July 2020

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Poster

Janssen Pharmaceuticals–Rapid Microbial Method Feasibility Study for J&J Biologics Production Process Monitoring

July 2014

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Poster

Optimization of Environmental Monitoring Incubation Parameters

July 2020

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Poster

Validation of and Corporate Value from Automation of Environmental Monitoring Test Methods

July 2020

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Poster

Is the Gold Standard Tarnished? Weaknesses in the Standard Method Compromise Your RMM Validation

July 2020

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Poster

Getting Lean–Benefits of Automation in the Microbiology Lab

July 2020

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Poster

Performance Comparability of Commercial Preparations of Test Organisms Used in the Validation of RMMs: Not All Bugs are Created Equal

July 2020

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Poster

Validation of an Automated Alternative Microbiology Method in the Age of Diverging Guidance

July 2020

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Poster

Data Integrity Compliance through Implementation of an Automated, Rapid, Microbiological Method

July 2020

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Whitepaper

Practical Applications for Automated Rapid Methods in Pharmaceutical Quality Control

July 2020

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Whitepaper

Determining Incubation Regime and Time to Results for Automated Rapid Microbiology EM Methods

July 2020

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Poster

Determination and Comparison of Time-To-Results Across Global Sites for EM Media via RMM

August 2021

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Poster

Disinfectant Neutralization Using Membrane Covered Culture Media

July 2020

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Poster

Using Swabs and Growth Direct™ System as Environmental Monitoring Application

July 2020

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Whitepaper

An Automated System for Rapid Non-Destructive Enumeration of Growing Microbes

July 2020

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Whitepaper

Quantifying the Economic Benefits for the Growth Direct System

July 2020

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Whitepaper

Rapid Enumeration of Bioburden in a Model Sample Matrix for Influenza Vaccine Using the Growth Direct™ System

July 2020

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Whitepaper

Rapid Enumeration of Bioburden in Fiber Wipes Using the Growth Direct™ System

July 2020

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Whitepaper

Exploring the Options for Integrating Automated Rapid Detection to LIMS

July 2020

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Whitepaper

Impact of Data Integrity Audits on Pharma Microbial QC Labs

July 2020

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Whitepaper

Effect of Incubation Regime and Media on Micro-Organism Detection for Environmental Monitoring

July 2020

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Whitepaper

Primary Validation of the Growth Direct™ Bioburden System and Media

July 2020

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Whitepaper

Primary Validation of the Growth Direct Environmental Monitoring System and Media

July 2020

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Whitepaper

Validation of the Growth Direct System for Microbial Environmental Monitoring and Define Optimal Incubation Conditions

July 2020

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Whitepaper

Rapid Enumeration of Biological Indicators Using the Growth Direct™ System

July 2020

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Poster

Determination and Comparison of Time-To-Results Across Global Sites for EM Media via RMM

March 2022

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Poster

Design Requirements for 21 CFR 11 Compliance and Manufacture 4.0 Readiness in a QC Micro Instrument

October 2022

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Fact Sheet

New for 2024 Sterility Testing

April 2024

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