Controlled Environment

A controlled environment is required in certain parts of a production facility in order to prevent contamination of the product. This can be done by controlling room conditions, but isolators and laminar flow units can create locally controlled environments.

Production Areas are classified depending on their purpose of use. A classified area must be controlled and monitored for temperature, humidity and particle levels. Air flows between areas must avoid contamination to higher graded area.

Isolators can be used to prevent the environment contaminating the product and/or prevent the product contaminating the environment. Gloves should be routinely integrity tested.

Internal sanitisation of isolators can be achieved manually or by using VHP equipment.

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