Tuesday Nov 26 2024 - 2:00 PM - 3:00 PM
Single-use, sterile disposable items – sterilisation and acceptance criteria
Single use sterile disposable technologies have great advantages in reducing turnaround times and the drain on plant utilities, as well as improving sterility assurance. However, such technologies also introduce potential risks.
In this webinar we focus on how to select and evaluate different technologies from a vendor, considering:
• Different sterilisation technologies
• How to assess shelf-life and what can go wrong, from discolouration to embrittlement
• How to ensure a sterile path - microbial immersion studies
• The risk of introducing toxic substances into the product - addressing through the use of leachable and extractables testing
• Vendor approval, management and the change control process
For aseptic processing the requirements of Annex 1 are clear – continuous monitoring. However, what about support rooms and the other areas of the facility where a product is made? How should monitoring frequencies for non-sterile areas be approached?
In this webinar, we consider:
• Risk based approaches to environmental monitoring
• The key factors that influence monitoring frequencies
• How to set a risk based approach for monitoring frequencies
• How to applying risk based methods to reduce the number of samples taken within a room
• How things can go wrong and what makes for a poor risk assessment
Click here to view on-demand.
Designing a contamination control strategy is central to the revision to EU GMP Annex 1. But how should this be approached? During this webinar, we explore the elements you need to consider when building a contamination control strategy. This includes designing a strategy that is holistic, interlined, and relevant.
A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event). This webinar presents the fundamentals of such a strategy.
Topic areas we cover include:
Click here to view on-demand.
The environment in which products are processed or within which the sterility test is conducted must be designed in such a way that the risk of contamination is minimised. The environment is designed to prevent cross-contamination, from the environment or from the operator, from occurring. The isolator provides the optimal means to achieve this.
However, poorly designed and maintained isolators can themselves be sources of contamination, arising from poorly executed decontamination cycles to leaks from gauntlets.
Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when designing, qualifying and operating isolators.
Topic areas we cover include:
Click here to view on-demand.
The revision to EU GMP Annex 1 calls for an environmental monitoring programme that is proactive, and risk based. The use of a simple ‘one size fits all’ approach to monitoring is no longer relevant.
This includes addressing issues like pre- and post-shutdown assessments of facility environments; selecting monitoring locations by risk assessment; addressing concerns with cleaning and disinfection; and adapting programmes for ageing facilities.
Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when fine tuning the environmental monitoring programme.
Topic areas we cover include:
Click here to view on-demand.
To avoid cross-contamination between different products and to remove residues and microorganisms, cleaning validation plays a central part in any pharmaceutical facility’s contamination control programme.
An effective approach to cleaning validation will be risk-based. A cleaning process has to be considered as any other process, for which critical process parameters have to be defined.
Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when putting together a cleaning validation strategy.
Topic areas we cover include:
Click here to view on-demand.
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.
Annette Russell has over 20 years’ pharma industry experience working in R&D on drug discovery programmes, as well on the commercial side, supporting numerous strategic accounts. Having joined the company six years ago, Annette is currently RSSL’s sterile and non-sterile microbiology commercial lead.
Annex 1 is a critical part of the European Union’s Good Manufacturing Practice (GMP) guidelines, specifically focusing on the manufacturing of sterile medicinal products. The revisions to Annex 1, which were finalised after years of industry input, have introduced significant changes aimed at enhancing product safety, quality, and sterility.
Annette Russell and Dr Tim Sandle are experts in pharmaceutical manufacturing and quality assurance in their respective fields. In this series of webinars, they break down the complex updates and new expectations set forth by the revised Annex 1.
The webinars cover key topics such as the heightened focus on contamination control strategies, the integration of Quality Risk Management (QRM) principles, and the implications for cleanroom design and operation.
By attending RSSL's Annex 1 webinars, you’ll be equipping your team with the knowledge and confidence to navigate these regulatory changes with ease.
