Sterile pharmaceutical preparations - injections, infusions and pharmaceutical forms for application on eyes and on mucous membranes - are expected to be efficacious and safe.
The safety includes being sterile and free from microbial toxins and visible particles. However, achieving sterility is not straightforward, requiring a series of manufacturing controls and sterilisation steps.
Assurance of sterility is obtained through an assessment of environmental controls, staff training, sterile components, environmental monitoring, and the end product sterility test. This means sterile products manufacturing itself is a continuum that stretches from development to manufacturing, to finished product, to marketing and distribution, and to utilisation of drugs and biologics.
The webinars are designed to cover the critical steps, focusing on the requirements of Good Manufacturing Practice (GMP) and the essential elements needed to develop a robust sterility assurance system and contamination control strategy.
WEBINAR: REVIEWING STERILE PRODUCTS - EXAMINING THE FACTORS REQUIRED FOR RELEASE
Wednesday 6 May 2020 14:00 – 15:00 (BST)
LEARNING OUTCOMES
- 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
To register for this webinar please click here
EXPERT WEBINAR SPEAKER
DR. TIM SANDLE
Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorials 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.
