(21 June 2.00pm - 3.00pm BST)
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
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