![]() Airborne particulates and the degree of filtration should be considered critical parameters with reference to the level of product protection required. design, layout, finishing), poor cleaning procedures, personnel, and a poor HVAC system.Ĭontaminants should be removed through effective ventilation. Note: Contaminants may result from inappropriate premises (e.g. Materials and products should be protected from contamination and cross-contamination through all stages of manufacture (See also section 5.5 for cross-contamination control). The clean-up time should be determined through validation and may typically be in the order of 20 minutes. Generally a room that is tested for an “operational” condition should be able to clean up to the “at-rest” clean area classification, after a short clean-up time. The “operational” condition should relate to carrying out room classification tests with the normal production process with equipment operating, and the normal number of personnel present in the room. Due to the amounts of dust usually generated in a solid dosage facility most clean area classifications are rated for the “at-rest” condition. The “at-rest” condition should relate to carrying out room classification tests with the normal production equipment in the room, but without any operators. The “as-built” condition should relate to carrying out room classification tests on the bare room, without any equipment or personnel. Sufficient air to maintain the required room pressureĮach clean area class should be specified as achieving the clean area classification under “as-built”, “at-rest” or “operational” conditions.Sufficient air to cope with the room heat load.Sufficient air to achieve containment effect. ![]() Configuration of the room and air supply and extract locations.Particulates generated by the operators. ![]() ![]()
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