Aseptic Processing & Sterilization

Time to Start Using Polypropylene Vials in the Industry

Ajay Pazhayattil, PhD, cGMP World, Prasanna Sagar, PhD, Itaan Pharma, and Praveen Joseph, IPS-Integrated Project Services

The Difficult Task of Solving Contamination Puzzles

Paula Peacos and Kim Sobien, ValSource, Inc.

Seven Key Takeaways from PDA’s Good Aseptic Manufacturing Conference

Patrick Nieuwenhuizen, PharmaLex

On The Issue: Digitalization of C.C.

PDA, Inc.

Understanding Disinfectant Efficacy for Off-Label Microorganisms

Mark Wiencek, Contec, Inc.

Don’t Miss the 2023 PDA Good Aseptic Manufacturing Conference!

Kerstin Wilken, IDT Biologika, and Paul Devuyst, GSK

Key Takeaways from the 2022 PDA Annex 1 Workshop in Dublin

Eilish Kelly and Patrick Nieuwenhuizen, PharmaLex

The Complex Process for Sterile Filling and Points to Consider

Mauro Giusti, Eli Lilly Italia, and Rebecca Brewer, QxP

Technological Solutions to Overcome the New Annex 1 Challenges

Marco Bianchi, De Lama S.p.A.

Microbial Control of Raw Materials Used in Pharmaceuticals

David Jaworski, PDA, Inc.

Missouri Valley Chapter Dinner Taps Inspections/Annex 1

Patrick Kane, Veltek Associates, Inc. and chapter board member

PDA Midwest Chapter’s Parametric Release Event – A Call to Action

Michael Sadowski, Baxter Healthcare Corporation

Investigating Out-of-Specification Results for BET

Hayden Skalski, Sievers Instruments

Contamination Control Strategies: A Path for Quality & Safety

Subrata Chakraborty, Gxpfont Consulting Group and Hal Baseman, ValSource, Inc.

Guest Editorial: What Might Have Been

Russell E. Madsen, The Williamsburg Group

PDA Visual Inspection Forum Returns; Lands in Berlin in 2022

John Shabushnig, PhD, Insight Pharma Consulting LLC, and Romain Veillon, PharmD, GSK Vaccines

Taking the Fear Out of Contamination: Surfaces, Water, and Air, Oh My!

Marilyn L. Foster, PDA, Inc.

Annex 1 and the New Revision — Setting New Expectations

Glenn Wright, PDA, Inc.

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

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