This paper outlines a systematic approach to detecting contamination through process deviations, including changes in % dissolved oxygen, pH, and metabolic patterns.

Unidentified microbiologist is place the petri dish and tubes into incubator to incubate the culture of bacteria or fungi growth in appropriate condition, concept of microbial laboratory. | Image Credit: © Sukjai Photo – © Sukjai Photo – Stock.Adobe.com

Evolving Cleanroom Procedures and Sterility Challenges

By Feliza Mirasol

April 4th 2025

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Cancer Question | Image Credit: ©freshidea - Stock.adobe.com

Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance

By Susan J. Schniepp

April 2nd 2025

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.

INTERPHEX 2025: Protecting Parenterals in Vials and Syringes with Functional Labels

By Patrick Lavery
Feliza Mirasol

April 2nd 2025

Speaking at INTERPHEX 2025, William Wainwright, business development manager at Iwata Label USA, discusses the practical benefits of functional labels in protecting parenteral drugs.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025

By Feliza Mirasol

April 2nd 2025

Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.

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