Environmental Growth Chambers (EGC)
Validation and Qualification Consultant
Dean Rainbolt is a seasoned professional in the pharmaceutical industry with an impressive 28-year tenure. His expertise spans multiple business units, including Development Stability, Corporate Reference Standards, Analytical Testing labs, and a Bio-Assay group, with a focus on Asset Management, validation, and Qualification services. A key influencer in the design and manufacturing of Ultra-Low temperature storage units, Dean has ensured compliance with GMP standards, particularly during the critical period of the COVID-19 pandemic. Notably, he led the core ISPE Good Practice Guide team through the second revision of the ISPE Good Practice Guide for Controlled Temperature Chambers. Additionally, Dean authored a groundbreaking white paper for a vaccine-manufacturing customer, which revolutionized cold storage qualification processes, reducing the time from 72 hours to 12 hours. This innovation resulted in a significant reduction of testing time, potentially saving the customer over 800 days across 350 storage units. Currently, Dean is a vital part of EGC (Environmental Growth Chambers), where his extensive experience continues to impact the industry.