RSSL Sterility Webinar Series

Hosted by Tim Sandle, RSSL's complimentary sterility webinar series continues throughout 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.





Spores in my Cleanroom – Remediation and Disinfection Strategies

Wednesday 29th September, 2.00pm - 3.00pm (BST)

Spores, both bacterial and fungal, presents problems for contamination control. Spores are very resistant to conventional cleaning and disinfection, with bacterial spores presenting a resistance problem and fungal spores presenting a particular risk in terms of dispersal.

Learning Outcomes:

  • Overview of spores - Bacterial and Fungal
  • Risks posed by spores to pharmaceutical operations
  • Sporidical disinfectants: Selection and concerns
  • Issue of disinfectant / sporicide resistance
  • Sources of spores

To register for this webinar please click here.



Water Systems – Microbial Monitoring and Qualification Strategy

Wednesday 27th October, 2.00pm - 3.00pm (BST)

Water is fundamental to pharmaceutical processing, from cleaning to use as an ingredient. Therefore, water system control is of fundamental importance. This webinar looks at best control and monitoring practices for pharmaceutical waster systems.

This Webinar Covers:

  • Water system – design and control
  • Biofilms
  • Microbiological concerns
  • Microbiological risks
  • Risk assessment
  • Microbiological tests and acceptance criteria
  • Why do failures happen?

To register for this webinar please click here.



Sterility Assurance in Cell Therapy Products

Wednesday 24th November, 2.00pm - 3.00pm (GMT)

Cellular therapy products represent a new wave in pharmaceuticals and include cellular immunotherapies, cancer vaccines and other types of both autologous and allogeneic cells for certain therapeutic indication. While the products are novel, sterility assurance concerns remain fundamental.

Learning Outcomes:

  • Sterility assurance principles
  • Sterility testing
  • Rapid microbiological methods
  • Environmental monitoring
  • Facility, equipment, raw materials, test system, and personnel
  • Control of the collection, processing, packaging, and distribution of cell products

To register for this webinar please click here.



Introduction to Mycoplasma and Cell Product Risks

Wednesday 22nd December, 2.00pm - 3.00pm (GMT)

Mycoplasma species are the most common contaminants in cellular therapies. This webinar introduces Mycoplasmas and outlines the risks they present and the remediation strategies required to control the microorganisms.

Learning Outcomes:

  • Risks posed to cellular products
  • Sterile filtration challenges
  • Surface adherence challenges
  • Sources of contamination including association with cell culture reagents
  • Remediation strategies, including donor material assessment
  • Regulations

To register for this webinar please click here.






ABOUT THE PRESENTER

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.






Missed our previous Sterility webinars?

Watch any of our previous Sterility webinars on demand by clicking on the related link below:

  • People in the Cleanroom – Contamination Risks, Clothing and Behaviours - click here
  • Cleanroom Design and Certification - click here
  • Essential Elements of a Contamination Control Strategy - click here
  • Quality Risk Management for Pharmaceuticals - click here
  • What can we expect from the new Annex 1? - click here
  • EU GMP Annex 1 - Implications for Sterile Products Manufacture - click here
  • Reviewing Sterile Products - Examining the Factors Required for Release - click here
  • Investigating Sterility Testing Failures - click here
  • Best Practices in Environmental Monitoring - click here

To learn more about RSSL's Sterility services please click here.



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