BS EN ISO 14644-7:2004 Cleanrooms and associated controlled environments. Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Part 7 of BS EN ISO 14644 specifies the minimum requirements for the design, construction, installation, testing and approval of separative devices of cleanrooms.
Difficulties experienced in the manufacture and handling of certain products or materials have driven the development of separative devices. These difficulties include product sensitivity to particles, chemicals, gases or microorganisms; operator sensitivity to the process materials or by products; and both product and operator sensitivity.
Separative devices provide assured protection in varying levels by utilising physical or dynamic barriers, or both, to create separation between operation and operator. Certain processes may require special atmospheres to prevent degradation or explosions. Some systems may be capable of providing 100 % recirculation of the contained atmosphere to allow inert gas operation or biodecontamination with reactive gases.
Usually people do not work directly inside the separative-device environment during production. These separative devices may be movable or fixed, and used for transport, transfer and process. The product or process, or both, are manipulated remotely with access devices either manually, with protection by barrier technology such as wall-integrated personal interface systems (e.g. gloves, gauntlets, half-suits), or mechanically with robotic handling systems.
Air cleanliness definitions and test methods covered in BS EN ISO 14644-1, BS EN 14644-2 and BS EN 14644-3 generally apply within separative devices. In applications with biological contamination requirements, BS EN ISO 14698-1 and BS EN ISO 14698-2 will apply. However, some applications can have special requirements for monitoring because of extreme conditions that may be encountered. These unique conditions are covered in this part of ISO 14644.
The application of this International Standard takes into account the following limitations.
- User requirements are as agreed by customer and supplier
- Application-specific requirements are not addressed
- Specific processes to be accommodated in the separative-device installation are not specified
- Fire, safety and other regulatory matters are not considered specifically; where appropriate, national and local regulations apply.
See other cleanrooms standards in the BS EN ISO 14644 series.
