This 90-minute webinar will present a scientific, risk-based approach to cleanroom management to help you ensure production of contamination free products that are safe for human use.
Why Should You Attend:
Consequences of not adequately managing cleanrooms are many, however the most critical is causing harm to the patient.
This session will start with a discussion on designing the cleanroom per product requirements. Additionally, you will understand the risk posed by inappropriate flows which can affect cleanroom environment. You will learn how to qualify the cleanroom by objectively evaluating the functioning capabilities of the HVAC system to meet pre-determined criteria - classification of cleanroom, acceptable levels of total particulate counts, viable particulate count, air flow rates, difference pressure, temperature, and humidity.
The presenter will provide a scientific risk based approach to cleanroom management as a sure way to ensure production of contamination free products that are safe for human use.
Areas Covered in the Seminar:
- Discussion on facility design as the first step.
- Cleanroom qualification – the measure for cleanrooms's capabilities.
- Material and personnel flows – points to consider.
- Cleanroom garments -regulations and guidances.
- Gowning rules - scientific rationale behind gowning.
- Dos and don'ts in cleanrooms as personnel behavior is a well known cause of contamination.
- Tracking and Trending of Environmental Monitoring Results, and methods for evaluating cleanrooms.
- Overview of HACCP principles for risk assessment.
- Benefits of assessing risk in cleanrooms.