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.

Click here to register