Annex 1 webinar series

This complimentary webinar series, hosted by Tim Sandle & Annette Russell, covers key Annex 1 focus areas.
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Design and qualification of isolators

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:


  • Isolator design and testing
  • Air and particulate control
  • Developing the best qualification approach
  • Fragility of vapour disinfection of isolators
  • Prerequisite tests for effective isolator operation
  • Vulnerability of isolator gloves and gauntlets
  • Qualifying isolators with chemical and biological indicators
  • Troubleshooting isolator operational problems

To view this webinar on-demand, please click here

Previous Annex 1 Webinars


    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:


    • Microbial contamination
    • Cleaning and disinfection
    • Sterility assurance
    • Facility design
    • Chemical and particle contamination
    • Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations


    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:

    • Contamination sources and vectors of contamination
    • Linking environmental monitoring to change control
    • Introducing risk based thinking to environmental monitoring sample selection and frequency determinations
    • Going beyond the standards
    • Linking monitoring to cleaning and disinfection
    • Using rapid microbiological methods appropriately
    • Connecting monitoring to facility maintenance
    • Linking monitoring to shutdowns
    • Tracking and trending microorganisms
    • Setting appropriate limits


    Click here to view on-demand. 

  • Disinfectant efficacy assessments are given greater prominence in the updated EU GMP Annex 1. Yet there are competing standards and different expectations for vendors and users.

    Cleaning and disinfection are essential for maintaining facility control. For the user, there are choices to be made between different agents, with application techniques, assessing biocidal efficacy, and addressing residues. Approaching these issues in the wrong way can be time consuming and expensive. This webinar offers a road map towards disinfection compliance.

    Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when designing a disinfectant efficacy programme.


    Topic areas we cover include:

    • Suspension testing – is there any value?
    • Approaching surface testing: how to run an effective study
    • Matrix approaches for surface selection
    • Designing a field trial
    • Incorporating neutralisers into culture media
    • Monitoring data for resistant strains
    • Supplier qualification and auditing
    • Internal controls and lot tracking


    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:


    • Critical Process Parameters (CPPs) for cleaning
    • Critical Quality Attributes (CQAs) for cleaning
    • Pre-requisites to begin cleaning validation
    • Introducing risk-based thinking into the cleaning validation process
    • Product and material groupings
    • Assessing hold times
    • Microbial attachment and removal
    • Selecting optimal analytical test methods
    • Why cleaning validation fails


    Click here to view on-demand. 


    Water is fundamental to pharmaceutical manufacturing yet a poorly designed or maintained water system can become the source of chemical or microbial contamination. Since water is ever present, each grade of water can present a contamination risk.

    Microbial contamination includes overall bioburden, the problems posed by specific species, and with the release of endotoxin.

    Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when addressing water system contamination issues, including addressing problems through repair, use of chemicals and heat.


    Topic areas we cover include:


    • Risks of microbial contamination
    • Biofilms
    • Good design issues – from flow rates to deadleg avoidance
    • Avoiding problems when water systems go off-line
    • Addressing contamination problems
    • Monitoring and trending
    • Learning points


    Click here to view on-demand.   

About the speakers:


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.

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