Donald Singer

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Donald Singer is senior global microbiology consultant with New Beginnings Microbiology, a Fellow in the American Society for Quality, and formerly with Ecolab Life Sciences.

Articles

Close-up of gloved hands in a cleanroom meticulously wiping a stainless steel surface. Maintaining sterility is paramount in this precise environment. | Image Credit: ©Aditya – stock.adobe.com

Considerations for Quality Improvement of Cleaning, Disinfection, and Cleaning Validation in Biopharmaceutical Manufacturing, Part I: Facility and Cleanroom Cleaning Practices

Thomas Altmann;Donald Singer;Stefan-Julian Frohberger

June 6th 2025

This paper highlights considerations based on risk that ensure ongoing success as well as improvement when applying cleaning and decontamination principles for biopharmaceutical cleanroom surfaces.

Refining Microbiological Control for Non-Sterile Products

James Agalloco;Donald Singer

October 21st 2020

Subsequent guidance and manufacturing realities make portions of USP Chapters <62 >and <111> significantly less relevant. The authors suggest formal chapter revisions.