Understanding Persistence, Regulatory Risks, and the Role of Specialized Expertise Authored by Darrell S. Ross, PhD Technical Review with Citations from Scientific Literature Abstract Biofilms—persistent microbial communities encased in self-generated extracellular polymeric substance (EPS) matrices—present one of the most formidable and persistent contamination and remediation challenges in pharmaceutical manufacturing, threatening both product sterility and integrity. The

By Darrell S. Ross, Ph.D. Abstract Passivation of austenitic stainless steels is a critical procedure for ensuring long-term corrosion resistance in demanding service environments. While QQ-P-35 and ASTM A-967 have historically served as foundational references for chemical passivation practices, both demonstrate substantial technical limitations when evaluated against current metallurgical understanding and modern processing requirements. This article provides an expanded ex

By: Darrell S. Ross Ph.D. – 2023 In the pharmaceutical industry, it is critical to ensure that the drugs that are being developed,...

By: Darrell S. Ross Ph.D. – 2023 This article will attempt to explain generally what cell capture and cell harvest are, how they work,...

By: Darrell S. Ross Ph.D. – 2023 This article will attempt to explain generally what the difference is between upstream and downstream...

By: Darrell S. Ross Ph.D. – 2023 Pathogens are microorganisms that cause infections, illness or disease in humans, animals, and plants....

By: Darrell S. Ross Ph.D. – 2023 This article will attempt to explain generally what parenteral drug products are, as well as their...

By: Darrell S. Ross Ph.D. – 2023 The pharmaceutical industry is driven by a commitment to patient safety and quality control. To achieve...

By: Darrell S. Ross Ph.D. – 2023 cGMP or current Good Manufacturing Practices is a series of guidelines and regulations that the...

By: Darrell S. Ross Ph.D. – 2023 Pharmaceutical aseptic manufacturing is a crucial and critical aspect of the pharmaceutical industry....

By: Darrell S. Ross Ph.D. – 2023 This article is intended to provide a brief overview of what an Active Pharmaceutical Ingredient is, as...