Tuesday, April 17 – Thursday, April 19, 2018
Javits Center | 655 W 34th St | New York, NY 10001
Be sure to stop by our booth #2057 and say hello to Kalpesh Patel and more!
Hyde’s experts will be presenting at INTERPHEX, be sure to check out more details below.
RONALD BERK – CHIEF TECHNOLOGY OFFICER
Topic: Remediation Challenges of Aging Facilities
Date: April 17, 2018
Time: 1:30 PM – 2:15 PM
Location: Technical Conference Stage 4
Aging is an unavoidable part of a facility’s life cycle. It is imperative that the facility owner constantly evaluate the impact of aging to the prime purpose of a GMP facility: consistent output of quality products. Aging of pharmaceutical manufacturing facilities has challenges in assessment and mitigation. This presentation will review some of the most common artifacts of aging, how to monitor the risk to supply chain interruption and, through some case studies, the challenges involved with mitigation or replacement of aging equipment or facilities.
Keith Bader – Senior Director of Technical Services:
Topic: Total Organic Carbon for Enhanced Verification of Bioprocess System Cleaning CQA’s
Date: April 18, 2018
Time: 3:15 PM – 4:00 PM
Location: Technical Conference Stage 3
In the manufacture of therapeutic and biocommodity products, contamination control is of paramount importance to product quality, efficacy, patient safety, and GMP compliance. Equipment cleaning is the primary line of defense in preventing adulteration by contaminants. Yet the control and monitoring of effective cleaning processes can be difficult. A survey of FDA warning letters found that 60 percent cited 21 CFR 211.67 (equipment cleaning and maintenance) deficiencies relating to inadequate equipment cleaning procedures, monitoring, and documentation (European Compliance Academy, 2006). While the industry has begun to integrate continuous monitoring technologies into manufacturing systems, cleaning systems are often overlooked in that effort. However, online TOC systems can be extremely useful not only for enhancing the control of critical cleaning process parameters but actually measuring forward processing criteria with the end goals of real-time release and continual verification. This presentation reviews the fundamentals of the cleaning process, important process parameters, and how appropriate instrumentation and control strategy can improve cleaning process control. Two case studies are also entertained in which TOC analyzers were implemented on CIP systems as well as the underlying philosophies that best fit the particular analyzers chosen.
More information on this event can is located here.