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Aseptic Processing & Sterilization

The Moldy Nightmare: Questions and Answers, Part 2

Ziva Abraham, Microlite, Inc.

Joint Associations’ Response Letter on EU Annex 1 Draft

Hal Baseman, Valsource, Inc and Annex 1 Response Team Co-Chair

The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration

William Peterson, Merck & Co.

States Temporarily Relax EtO Restrictions

Rebecca Stauffer, PDA

Visual Inspection Practices of Cleaned Equipment: Part II

Walid El Azab, STERIS, and Stephane Cousin, GSK

Visual Inspection Practices of Cleaned Equipment: Part I

Walid El Azab, STERIS, and Stephane Cousin, GSK Vaccines

CMO Works Around the Clock to Produce COVID-19 Meds

Rebecca Stauffer, PDA

Real-World Applications of Rapid Micro Methods

Tony Cundell, PhD, Microbiological Consulting, and Michael Miller, PhD, Microbiology Consultants

Sterility Test Failure Investigations

Rebecca Stauffer, PDA

Innovations in Aseptic Processing

Rebecca Stauffer, PDA

How to Qualify Your Disinfectants

Michael Hodgkinson, Orvera Scientific

Tri-Spine Crab Now on Endangered List

James Cooper

Are Your RMM Organisms Reflective of Your Process?

Irving Ford, Celgene

PUPSIT and the Annex 1 Revision

Tina Morris, PDA, Maik Jornitz, G-Con, Gabriele Gori, GSK, and Hal Baseman, ValSource

Lifecycle Approach Wipes Away Cleaning Validation Concerns

Raji Vathyam

ISO 22519: A Flawed and Counterproductive Standard

A Team of Pharmaceutical Water Experts

New ISO Standard Available for Water Systems

Shlomo Sackstein, Biopuremax

Aseptic Technology Advances to the Next Level

Subrata Chakraborty, Cipla

Highly Potent APIs: Balancing Patient and Operator Safety

Rebecca Stauffer, PDA

A Patient’s Life Depends on Product Quality

Jason O’Hare, Charles River

B. cepacia: What is it and Why is it a Concern?

Marc Baiget Francesch, Tiselab

PDA Addresses LER in TR, Forthcoming Book

Rebecca Stauffer, PDA

Response to "Standing Guard"

Kevin L. Williams, bioMérieux

An Overview of Container Closure Integrity

Qingyu Zeng, PhD, West Pharmaceutical Services, Inc.

Hidden Contamination in Starting Materials

Annette Kirsch, PhD, Merck KGaA

Endotoxin Testing Using Recombinant Reagents

Karolina Heed, Hyglos - a bioMérieux company

Does QRM + RMM = Better EM?

Dalmaso Gilberto, PhD, and Lisa G. Lawson, Particle Measuring Systems

What Annex 1 Means for Sterilization and Moist Steam

Walid El Azab, STERIS Life Science

Draft Annex 1 Separates Cleaning and Disinfection

James Tucker, Ecolab Life Sciences

Revised USP Micro Chapters Address Changing Technologies

David Hussong, PhD, Eagle Analytical Services, Radhakrishna Tirumalai, PhD, USP, Edward Tidswell, PhD, Merck, and Donald Singer, GSK