Reviewing sterile products - examining the factors required for 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.