WEBINAR TODAY: Risk matrix approach for media simulation trials
LAST CHANCE TO REGISTER! Thermo Fisher Scientific and Cleanroom Technology present a webinar looking at the key issues of media fill trials in aseptic processes for sterile pharmaceuticals
The manufacture of sterile drugs or APIs is complex and challenging. Because aseptically filled products contain molecules that, due to their nature, cannot be terminally sterilised, the filling process must be assessed to ensure that there is no risk of contamination.
The main evaluation tool is a process simulation in which culture media is filled instead of the real product into the actual containers. This provides information as to whether the process compromises the sterility of individual components and finished product.
Media trials use a microbiological growth medium in place of product to simulate the product fill process; the media is processed in a manner identical to that in which the product is handled. To provide a robust test, a media fill programme must incorporate the contamination risk factors that occur on a production line and accurately assess the state of process control.
Thermo Fisher Scientific and Cleanroom Technology are presenting a webinar TODAY, Wednesday 24 September at 9:00am CST, 3:00pm BST, 4:00PM CET. Entitled 'Risk Matrix Approach for Media Simulation Trials in Sterile Pharmaceutical Manufacture', the webinar will explore important factors to consider when designing a media simulation trial programme, and examine how these factors can be used to establish a risk-based matrix. You will also learn how single-use technology can aid safe and simple validation of aseptic manufacturing processes.
The speakers will be Dr Tim Sandle, Head of Microbiology at Bio Products Laboratory, UK, and Colin Booth, Global Director of Quality Assurance and Regulatory Affairs, Microbiology Products, at Thermo Fisher Scientific.
