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ARCHIVED NEWSLETTERS

bullet Volume 19, Number 2  2013
bullet Avoiding Dilution Error With the LAL Assay - Dr. Tim Sandle  
bullet Update of USP Drug Testing Reference Strain ATCC® 2601TM  - Sung-Oui Suh, Brian Beck, Liz Kerrigan, and Jianlong Jim Zhou  
bullet Volume 19, Number 1  2013
bullet The Current State of Rapid Microbiological Methods - Dr. Michael J. Miller
bullet Variability and the LAL assay - Dr. Tim Sandle
bullet Volume 18, Number 5  2012
bullet Training on the Right Things in the Microbiology Laboratory  - Tony Luttrell
bullet European Pharmacopeia Proposes Revision to Biological Indicators Chapter - Tim Sandle, PhD
bullet Volume 18, Number 4  2012
bullet Articles of Interest -2011 
bullet Upcoming PMF Conferences
bullet Volume 18, Number 2  2012
bullet Qualification of a Contract Microbiology Laboratory - Scott Sutton, PhD 
bullet Current Contract Manufacturing Operation (CMO) Regulatory Issues - Barry Friedman, PhD
bullet Upcoming PMF Conferences
bullet Volume 18, Number 1  2012
bullet The Use of In-House Microbial Isolates in Compendial Testing - Robert Westney 
bullet Recent Developments in European Regulatory Requirements: Issues Affecting the Microbiologist  - Tim Sandle, PhD
bullet Upcoming PMF Conferences
bullet Volume 17, Number 8  2011
bullet Results of the PMF Water Testing Survey - Robert Westney 
bullet Sterility Test Requirements for Biological Products - Tim Sandle, PhD
bullet Volume 17, Number 5  2011
bullet Biological Indicators for Steam Sterilization: Failure Investigations - Tim Sandle 
bullet Establishment of Time Limits for Sterilized Materials and Equipment - Robert Westney, Mark Fosbenner and Eric Staib
bullet Volume 17, Number 4  2011
bullet 2010 Articles of Interest
bullet Volume 17, Number 3  2011
bullet The Definition of “Trend” and “Adverse Trend” in Environmental Monitoring - PMF Non-sterile EM Survey Team  
bullet Filamentous Fungi and their Implications in a GMP Environment—Anethra Wilson  
bullet Volume 17, Number 2  2011
bullet Controlling Biofilms in Pharmaceutical Water Systems: Lessons Learned from Clinical Water Systems.   Mark Pasmore and Deborah Czarnecki
bullet Volume 17, Number 1  2011
bullet Risk Analysis of Injectable Products’ Microbiological Quality in Aseptic Processing Facility - Fernández J, et al
bullet The USP/NF Viewed As A Network - David A. Porter, Ph.D.
bullet Volume 16, Number 12  2010
bullet Standard Operating Systems Viewed As Dynamic Networks - David Porter, Ph.D.
bullet Changes to the European Pharmacopoeia: 2008 - 2010 - Tim Sandle, Ph.D.
bullet Recent Warning Letters Review for Preparation of (an Aseptic/a Non-sterile) Processing Inspection (In Two Volumes) - By Jeanne Moldenhauer:  Book Review by Scott Sutton
bullet Volume 16, Number 3  2010
bullet The Antimicrobial Effectiveness Test - Scott Sutton
bullet Volume 16, Number 2  2010
bullet The Most Probable Number Method (MPN) - Scott Sutton
bullet PIC/S Guide on Aseptic Processing - Tim Sandle
bullet Volume 16, Number 1  2010
bullet Articles of Interest - 2009
bullet Volume 15, Number 12  2009
bullet Keys to Successful Laboratory Testing - Sherri Robbins
bullet Microbiological Issues in Process Equipment Cleaning Validation Part II: Clean Hold Times - Destin LeBlanc
bullet New Email Discussion Group: C-CEList Cleanrooms and Controlled Environments - Anne Marie Dixon
bullet Volume 15, Number 11  2009
bullet Microbiology and the World Wide Web - Tim Sandle
bullet Non-Destructive Characterization of a Steam System Biofilm by Microscopy - Mark Fornalik, Betsy Pitts, and Jill Fornalik 
bullet Volume 15, Number 10  2009
bullet Microbiological Issues in Process Equipment Cleaning Validation Part I: Basic Issues - Destin LeBlanc
bullet Regarding the Validation of Water Bath - Message Thread on PMFList
bullet Volume 15, Number 9  2009
bullet Microbiology Education and Industry Expectations: A Reality Check - J. Kirby Farrington, Ph.D. 
bullet USP Changes in 2009 of Interest to the Microbiologist - Scott Sutton, Ph.D.  
bullet Volume 15, Number 8  2009
bullet Managing Laboratory Waste: A UK Perspective - Michael Graz, PhD
bullet USP Chapter <1058> Analytical Instrument Qualification - Scott Sutton, PhD
bullet Volume 15, Number 7  2009
bullet The All-important Fine Details Underlying an Effective Cleaning and Disinfection Program - Jay Glasel
bullet Handwashing and the GMPs - Scott Sutton
bullet Volume 15, Number 6  2009
bullet Biofouling Characterization in Two Winery Process Lines  - Mark Fornalik
bullet Justification of the Use of Alternative Standard Reference Microbial Cultures in Biosafety Level 1 Laboratories    - Kirk Douglas
bullet Book Review - Water Activity Applications in the Pharmaceutical Industry (Cundell and Fontana, ed)  - Scott Sutton
bullet Volume 15, Number 5  2009
bullet Is This Contract Microbiology Laboratory Qualified to Perform Testing? - Scott Sutton 
bullet Volume 15, Number 4  2009
bullet Alfred Theodore MacConkey - Satish Rana
bullet Quality Control: Certified NRCM Workforce - Peggy McNult and Donald Singer
bullet Disposable Paper Towels vs Hot Air Dryers? - Scott Sutton
bullet Volume 15, Number 3  2009
bullet

Articles of Interest - 2008

bullet Volume 15, Number 2  2009
bullet An Examination of the Sample Hold Times in the Microbiological Examination - Tim Sandle, Jennifer Roberts and Kerry Skinner
bullet How to Prepare Data for Statistical Analysis - David Porter
bullet PMF Puerto Rico Sessions - GMP, Validation and Investigations
bullet Volume 15, Number 1  2009
bullet Importance of the Bioburden Test in Pharmaceutical Quality Control - S. M. Jobair Hossain
bullet Biological Indicators, D-Value and Population Verification/Assessment - Russ Nyberg
bullet PMF Puerto Rico Sessions - GMP, Validation and Investigations
bullet Volume 14, Number 12  2008
bullet pH Measurements in the Microbiology Laboratory - Courtland Imel
bullet The Revised cGMP - 21 CFR 211 (effective December 8, 2008)
bullet Survey on PMF Services
bullet Volume 14, Number 11  2008
bullet Development of TGO 77 - Microbiological Standards for Medicines - Scott Sutton
bullet Organizational Tools for the Microbiology Lab - Kathleen Zagaroli
bullet Recent and Upcoming Pharmacopeial Forum Changes of Interest
bullet Survey on PMF Services
bullet Volume 14, Number 10  2008
bullet Reclassification of ATCC® 16404TM and ATCC® 9642TM as Aspergillus brasiliensis  - Jan Houseknecht, Elena Stamenova, Sung-Oui Suh, Brian Beck, Marian McKee, and Jim Zhou 
bullet What does this Reclassification of ATCC® 16404TM and ATCC® 9642TM Mean to the QC Microbiology Lab? - Scott Sutton
bullet Recent and Upcoming USP Microbiology Changes - Scott Sutton
bullet Volume 14, Number 9  2008
bullet FDA and Investigations of Microbiological Data Deviations (MDD) - Scott Sutton
bullet Volume 14, Number 8  2008
bullet Qualification of an Environmental Monitoring Program - 1. Selection and Justification of Sample Sites - Scott Sutton
bullet Questions from the PMFList
bullet Volume 14, Number 7  2008
bullet Antibiotic Potency Assays as Described in USP Chapter <81> - David L. Gibbs
bullet Biological Safety Cabinets - Scott Sutton
bullet PMF Fall Conferences
bullet Volume 14, Number 6  2008
bullet PMF Conferences During the First Half of 2008
bullet New Chapters of Interest in the Pharmacopeial Forum
bullet Surface Sampling Methods for Bioburden - Scott Sutton  
bullet Volume 14, Number 5  2008
bullet Sterility Assurance Level (SAL) - The term and its definition continues to cause confusion in the industry - Gregg Mosley
bullet Brevundimonas diminuta is not always so diminutive - Growth conditions affect size - Julie Schwedock
bullet Volume 14, Number 4  2008
bullet A Practical Example Arising from the Harmonization of the Microbial Enumeration Method for Water - Tim Sandle and Kerry Skinner
bullet Pathogen Recovery Through Effective Sampling Technology - Bruce Bradley, Ph.D., Kevin Church, Jared Maughan
bulletLetter to the Editor - Gary Jackoway
bullet Volume 14, Number 3  2008
bullet Fundamental Elements of Cosmetic and OTC Drug Microbiological Quality - Phil Geis
bullet Bibliography - 2007
bullet Volume 14, Number 2  2008
bullet Examination of Microbiological Quality of Pharmaceutical Raw Materials - Bomlies, Weiß and Beckmann
bullet Are All Identical Culture Collection Strains the Same? - Scott Sutton
bullet Volume 14, Number 1  2008
bullet Microbiological Considerations For Sterilization Process Development - Anne F. Booth
bullet Harmonizing a Microbial Enumeration Method for Water - T.C. Soli
bullet  Featured PMFList Sponsor - Raven Labs
bullet Volume 13, Number 12  2007
bullet The Importance of a Strong SOP System - Scott Sutton
bullet A Status Report on the PMFList
bullet Volume 13, Number 11  2007
bullet Seed Lot Technique - Scott Sutton
bullet A Warning Letter about Process Control
bullet From the News Wire
bullet Volume 13, Number 10  2007
bullet Some Considerations on the Use of Endotoxin Indicators in Depyrogenation Studies - Tim Sandle
bullet Validation of Microbial Recovery from Surfaces - Scott Sutton
bullet Volume 13, Number 9  2007
bullet The Importance of Water Sampling - TC Soli
bullet Microbial Recovery Studies - 50% or 70%? - Scott Sutton
bullet The PMF Fall Conference Schedule
bullet 2008 PMF Conference Schedule
bullet Volume 13, Number 8  2007
bullet Microbiological Aspects of Stability - Scott Sutton
bullet Biosafety in the QC Microbiology Laboratory
bullet The PMF Fall Conference Schedule
bullet Recent Hand Washing Articles of Interest
bullet Volume 13, Number 7  2007
bullet Recent Announcements of Interest in Pharmacopeial Forum
bullet Effect of Membrane Filter Pore Size on Microbial Recovery and Colony Morphology
bullet Recent News
bullet Jobs
bullet Volume 13, Number 6  2007
bullet A Practical Approach to Conducting Microbial OOS Investigations - Frank Settineri
bullet Microbiology in the Contamination Control Plan - Scott Sutton
bullet The LAL User’s Group is Back!
bullet Call for Abstracts - 2007 PMF Fall Forum
bullet Volume 13, Number 5, 2007
bullet The USP Process - David Porter
bullet Who is a Microbiologist? - Scott Sutton
bullet Book Review Cleaning Validation (Destin A. LeBlanc) 
bullet Volume 13, Number 4, 2007
bullet Vitek 2 Compact: Its Use in a QC Microbiology Lab - Max Dolgopyat
bullet USP <1117> Microbiological Best Laboratory Practices - Scott Sutton
bullet 2007 PMF Validation Conference in Ft Worth, TX
bullet Volume 13, Number 3, 2007
bullet Exactly…How Many! Real-Time Quantitative Polymerase Chain Reaction (qPCR) - Janet Barletta
bullet Articles of Interest: 2006 - Scott Sutton
bullet The Open Conference Was a Great Success!
bullet PMF’s GMP in Microbiology Conference

bullet

Volume 13, Number 2  2007
bullet Cryopreservation of Bacteria - Liz Kerrigan
bullet Are Microbiologists Developing R2 Envy? - David Porter
bullet The New USP Chapter “<1072> Disinfectants and Antiseptics” - Scott Sutton
 
bullet Volume 13, Number 1  2007
bullet A Practical Approach to Understanding and Controlling Biofouling in Liquid Transfer Equipment - Mark Fornalik
bullet How Do You Decide Which Microbial Identification System is Best? - Scott Sutton
bullet 2007 PMF Open Conference on Compendial Issues
 

bullet
Volume 12, Number 12  2006
bullet The Revision Process at the United States Pharmacopeia - David Porter
bullet Streaking for Single Colonies - Scott Sutton
bullet Q10 : Pharmaceutical Quality Systems
bullet PMF Newsletter Articles for 2006
 
bullet Volume 12, Number 11  2006
bullet Cleanrooms and Controlled Environments - Anne Marie Dixon
bullet Microbiological Data Deviations - Scott Sutton
bullet 2007 PMF Open Conference on Compendial Issues  ANNOUNCEMENT
bullet 2006 PMF Fall Forum
 
bullet Volume 12, Number 10  2006
bullet Understanding Water Activity - Anthony Fontana
bullet PMF Open Conference on Compendial Issues  ANNOUNCEMENT
bullet A Conversation with FDA about "Counting Colonies" - Scott Sutton
bullet The Bacterial Endotoxin Summit - San Francisco
bullet Volume 12, Number 9  2006
bullet Counting Colonies - Scott Sutton
bullet The Purpose of Cosmetic Preservation - Phil Geis
bullet ATCC Standards Resource - Joe Parrone
 
bullet Volume 12, Number 8  2006
bullet Microbial Identification by FAME - Jeff Little
bullet Measurement of Cell Concentration in Suspension by Optical Density - Scott Sutton
bullet 2006 PMF Fall Forum Announcement
bullet Book Review - Good to Great by Jim Collins
 
bullet Volume 12, Number 7  2006
bullet How to Determine if an Organism is “Objectionable” - Scott Sutton
bullet Is the Time Right to Include Microbiology in USP Chapter <16> Automated Methods of Analysis? - David Jones
bullet The 2006 PMF Conference on GMPs in Microbiology
bullet The Three Monkeys - Renaud Jonquières
bullet 2006 PMF Fall Forum
 
bullet Volume 12, Number 6  2006
bullet Review of The Parenteral Society and The Scottish Society for Contamination Control’s Risk Management of Contamination (RMC) During Manufacturing Operations in Clean rooms (Technical Monograph No. 14) - Eric Strauss
bullet Microbial Limits Tests The Difference Between “Absence of Objectionable Microorganisms” and “Absence of Specified Microorganisms” - Scott Sutton
bullet Who is in Charge of the Micro Lab? - MCSR
bullet Supplement 2 to USP 2006 Released
bullet  Harmonized Microbial Limits Chapters<61>, <62> and <1111> (effective August 1, 2007)
bullet <1072> Disinfectants and Antiseptics
bullet <1112> Application of Water Activity Determination to Nonsterile Pharmaceutical Products
bullet <1117> Microbiological Best Laboratory Practices
bullet <1223> Validation of Alternative Microbiological Methods
 
bullet Volume 12, Number 5  2006
bullet Follow-up to April's RiboPrinter Article - Little, Sherriff & Sutton  Dupont's Guidance on Manual ID
bullet DNA Fingerprinting: Basic Principles of Data Analysis - Grace Thornhill
bullet Biological Indicators and Third Party Verification - Russ Nyberg
bullet 483s from 2005 - Richard Almond
bullet Book Review: Pharmaceutical Filtration by T Meltzer and M Jornitz
 
bullet Volume 12, Number 4  2006
bullet The Harmonization of the Microbial Limits Tests; Absence of Specified Microorganisms - Scott Sutton
bullet The Importance of Data Analysis in DNA Fingerprinting - Jeff Little
bullet RMUG - Rapid Microbiology User's Group - Call for Subscribers
bullet Book Review - Quality Control Systems for the Microbiology Laboratory: The Key to Successful Inspections by Lucia Clontz (DHI Publications) 2001
 ..
bullet Volume 12, Number 3  2006
bullet The Harmonization of the Microbial Limits Tests; Enumeration - Scott Sutton
bullet 483 Alerts - Richard Almond
bullet The Bacterial Endotoxin Summit
bullet Microrite's BactiSpell 2006 - Ziva Abraham  Zipped Copy of Files
bullet 2005 Bibliography of Useful Articles
 
bullet Volume 12, Number 2  2006
bullet Purified Water and WFI Alert and Action “Limits” - TC Soli
bullet The Gram Stain - Scott Sutton
bullet Mike Korczynski, a Gentleman, a Scholar, and a Friend - Roger Dabbah
 
bullet Volume 12, Number 1  2006
bullet Quality Control of Microbiological Media - Scott Sutton
bullet PAT and Real Time Release - Is This Proposal Workable? an essay by "Microbiologists for Common Sense and Reason" (MCSR)
bullet Book Review - Endotoxins by K.L. Williams
 
bullet Volume 11, Number 2, 2004
bullet USP Proposed Chapter "<1117> Good Microbiological Laboratory Practices"
 
bullet Volume 11, Number 1, 2004
bullet Environmental Monitoring
 
bullet Volume 10, Number 2, 2003
bullet Using Biolog Technology for Fungal Identifications
 
bullet Volume 10, Number 1, 2003
bullet Development of Precise Quality Control
 
bullet Volume 9, Number 2, 2002
bullet Sterilization and Sanitization - Are They Really Different?
 
bullet Volume 9, Number 1, 2002
bullet Accuracy, Precision and Sensitivity of Microbiological Assays
bullet PMFList thread on QC of Environmental Monitoring Media
 
bullet Volume 8, Number 2, 2001
bullet Failure Investigations, A Key Problem Area During FDA Inspections Still
bullet PMFList thread on media fills
 
bullet Volume 8, Number 1, 2001
bullet Utilizing Environmental Monitoring Data to Implement a Cleaning and Disinfectant Program
bullet PMFList Thread on preparation and use of disinfectants
 
bullet Volume 7, Number 3, 2000
bullet Salary Survey
 
bullet Volume 7, Number 2, 2000
bullet Microbial Identification "A Mystery"
bullet BI Spore Strip Validation
bullet AAI Highlights Microbiology Seminar
 
bullet Volume 7, Number 1, 2000
bullet Microrite Bactispell Software
bullet AAI 9th Annual Microbiology Seminar 
bullet Volume 6, Number 4, 1999
bullet Changes to USP Microbiology Chapters
bullet Poster Presentation - Comparison of Biolog and Vitek for ID of gram (-) bacteria in manufacturing 
bullet Fall, 1999 - volume 6 number 3 
bullet USP Article
bullet Highlights of AAI Microbiology Seminar
 
bullet Summer, 1999
bullet Validation of Biologics
bullet Highlights of AAI Microbiology Seminar
 
bullet Spring, 1999
bullet Water Activity and Microbes
bullet USP Open Conference
bullet Y2K Compliance in a Microbiology Lab
 
bullet Winter, 1998
bullet USP Open Conference
bullet PMF Survey Results
bullet Nanobacteria
 
bullet Fall, 1998
bullet Internet Resources for the Pharm. Worker
bullet 7th Annual Microbiology Seminar
 
bullet Summer, 1998
bullet Internet Resources for the Pharm. Worker
bullet 7th Annual Microbiology Seminar
bullet Microbial ID Systems Survey
 
bullet Spring, 1998
bullet Considerations and Limitations of Isolation Technology and Vapor Phase Hydrogen Peroxide
 
bullet Winter, 1997
bullet 1997 Salary Survey
 
bullet Fall, 1997
bullet The Microbiology BBS
bullet Regulatory Issues Associated with QC Microbiology Laboratories
bullet Computer Validation
 
bullet Summer, 1997
bullet USP Workshop
bullet AAI Microbiological Attributes Seminar
bullet Pharmaceutical Microbiology Internet Sites
bullet Benchmarking Survey Results
bullet Salary Survey
 
bullet Spring, 1997
bullet Regulatory Compliance Issues in the Microbiology Laboratory
bullet International Harmonization of Sterility and Antimicrobial Effectiveness Tests
bullet Interpharm Harmonization Meeting of the EP, JP and USP, Barcelona, Spain
bullet Highlights of the PDA 1996 Annual Meeting
 
bullet Winter, 1996
bullet Microbiological Requirements for Stability Studies
bullet Japan Regulatory and Compendial Issues
bullet Environmental Monitoring
bullet Pharmaceutical Microbiology in Japan
 
bullet Summer, 1996
bullet The Microbiology BBS
bullet USP Microbial Requirements
bullet USP Sterility Testing
bullet BET
bullet Microbial Purity
 
bullet Spring, 1996
bullet Summary/Review of USP's Open Conference held in Ft. Myers, FL January 11-13, 1996
 
bullet Winter, 1995  (date on header incorrect)
bullet Summary of the 1995 AAI Microbiology Series
bullet Cleaning Validation
bullet Validation of a WFI system 
bullet Summer, 1995
bullet Summary of the 1995 AAI Microbiology Series
bullet Container Closure Testing 
bullet Spring, 1995
bullet A Microbiologist on a cleaning validation team
bullet Results from purified water survey 
bullet Winter, 1994
bullet Answers to survey in summer issue 
bullet Summer, 1994
bullet Review of 1994 PMF Annual Meeting
bullet Sterility Failure Investigations 
bullet Spring, 1994
bullet Purchasing a new autoclave
bullet Biological Indicators 
bullet October, 1993 
bullet Formation of PMF
bullet Irradiated vs. non-irradiated RODAC plates