Watch this great webinar featuring Igor Gorsky as he discusses how to develop a fast cleaning validation protocol.
Cleaning validation plays an important role in reducing the possibility of product contamination and carryover from pharmaceutical manufacturing equipment. Cleaning verification demonstrates that the cleaning process adequately and consistently removes product residues, process residues and environmental contaminants from the manufacturing equipment, so that this equipment can be safely used for the manufacture of specified subsequent products. How quickly production equipment can be verified clean is a critical rate-limiting step of manufacturing efficiency. Historically, the analytical testing had been time-consuming, and can keep production equipment offline for days.
The ability to perform fast analysis of a large number of samples to check for the presence of residual API and/or cleaning agents, is a growing need of the global pharmaceutical manufacturing industry. New process analytical technologies enable production of more pharmaceutical products faster and at a lower cost. The industry needs to evaluate and embed new technologies to improve cleaning validation cycle times and reduce costs. Ion mobility spectrometry (IMS) can enable rapid cleaning verification programs.
Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He has held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He previously worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of GlobaPharmaceutical Technology at Shire. Currently, he acts as Principal Process Validation Consultant at Valsource. His accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion-dollar drug product lines and introduction of new products onto the market. He has published numerous articles and white papers in pharmaceutical publications and has been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops and other forums. He is also very active with PDA, participating in several task force groups and authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), 60-2 (Process Validation Annex 1: OSD and SSD Dosage). In addition, he leads the PDA Water Interest Group and is also a member of ASTM E55, one of the authors of ASTM E3106 Cleaning Process Development and Validation, ASTM E3219 Derivation of Health Based Limits, ASTM E3263 Visual Inspection, ASTM G121 Preparation of Coupons for Cleaning Agents. He is an author of two books on Process Scale Up and Validation. He holds a BS degree in Mechanical/Electrical Engineering Technology from Rochester Institute of Technology.