Cleaning Process Validation Specialist

Jayen Diyora, with over thirteen years of experience in the biopharmaceutical manufacturing sector, has been instrumental in advancing cleaning process validation—a crucial yet often overlooked aspect of pharmaceutical production. His career is marked by a deep commitment to improving pharmaceutical products' efficacy, safety, and quality through thorough cleaning validation practices. In the industry, cleaning validation is essential to ensure that production equipment does not introduce contaminants into the products, which is vital for both patient safety and product integrity. Historically, about 20% of regulatory observations from 2009 to 2023 have identified shortcomings in this area, particularly under the guidelines 21 CFR 211.67(a) and 21 CFR 211.67(b).
Moreover, inefficiencies in cleaning validation can cause significant operational disruptions and reduce Overall Equipment Effectiveness (OEE). He emphasizes the importance of optimizing cleaning and setup processes, which currently consume about 20% of operational time, thereby presenting significant opportunities for increased productivity and waste reduction. He promotes a scientific, risk-based, and statistically driven approach to cleaning validation, incorporating lab-scale development, optimization of cleaning processes, and rapid residue detection techniques. These innovations help minimize environmental impact, optimize resource use, and reduce waste. He has also focused on managing water used in production and cleaning processes, aiming to conserve this vital resource and reduce the related energy and carbon footprint through the adoption of eco-friendly technologies and efficient practices.
Additionally, his involvement with the ASTM cleaning standards team advocates for a shift towards more resource-efficient and less burdensome validation practices, especially for low-risk products like Active Pharmaceutical Ingredients (APIs), categorized based on Health Based Exposure Limits (HBEL). This approach not only aligns with stringent regulatory standards but also enhances operational efficiency and fosters environmental sustainability.
Through these efforts, Diyora aims to set new benchmarks for sustainable manufacturing, ensuring that the biopharmaceutical industry not only meets regulatory demands but also advances global sustainability goals. His comprehensive approach to cleaning validation is essential for the industry to adapt to evolving demands while maintaining its commitment to patient safety and product quality.