Reviewing sterile products - examining the factors required for release

This complimentary RSSL webinar series following the launch of RSSL's sterility testing service, will guide you through the complexities around sterile products manufacturing, control, testing and release.

Topic areas we cover include:

• Gain an insight into the critical microbiological quality attributes required for the manufacture of sterile products, including bioburden and endotoxin control
• Assess the physical control factors to support sterile products manufacture, from sterile filter integrity testing to cleanroom certification
• Understand the types of controls required for fill and finish activities, in line with current GMP
• Review a holistic approach for batch release based on ensuring there is an assurance of sterility

Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorial boards and he has written over six hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.