RSSL Sterility Webinar Series: Cleanroom Design and Certification
: 30 Jun 2021
Hosted by Tim Sandle, RSSL's complimentary sterility webinar series continues throughout 2021, with more sessions to guide you through the complex world of Sterility Testing.
Focusing on the latest draft of the EU GMP Annex 1 for sterile products manufacture, the series will discuss the different aspects that all manufacturers need to consider to remain compliant, including quality risk management, contamination strategy, cleanroom certification, and water systems.
Cleanrooms provide the structure within which pharmaceutical processing takes place, yet many in production and quality departments are not familiar with the design, operational, and certification requirements.
The revised Annex 1 sees a considerable expansion in scope when it comes to cleanroom design. This webinar outlines the current thinking on the subject.
- To understand the essentials of cleanroom design to achieve contamination control and compliance: filtration, air exchanges, air movement, pressure differentials and construction
- To consider the certification to cleanrooms according to ISO 14644 and EU GMP best practices, including assessments of particles, microorganisms, and appropriate physical parameters
Contact us for more information