Isolators create a closed, contained and controlled environment, now widely used in aseptic processing for high level control of aseptic assurance to meet cGMP requirements. In this webinar, isolator case studies will be reviewed, starting from its design, manufacture and validation. Main function or design elements such as unidirectional airflow, pressure differential control, leakage test of isolator chambers, VPHP decontamination functions will be discussed. Innovations, for example the Visual Reality supported Mockup will also be introduced, based on Covid-19 pandemic situation.
• Definition of Pharmaceutical Isolators & Why Isolator Technology?
• Factors that Affect VPHP Decontamination
• Knowledge of Online Environment Monitoring Design Inside Isolators based on Risk Assessment.
Sanjeev Patki, Business Development Director, Tofflon Science and Technology Co. Ltd
Sanjeev is a pharma professional with over 34 years’ extensive and rich experience in:
- Sterile manufacturing of small volume parentals including lyophilization
- Monitoring and auditing of CRO, CMO, API, Excipients and Primary Packaging materials
- Establishment of “Cold Chain“ for vaccines for current local and international quality and regulatory standards
- Deviation, Risk Assessment and Change Control Management, Technology Transfers and Validation
He is also experienced in set up of production facilities for manufacturing sterile liquid injectables including vaccines, formulations, biotech and API.