Utilities that could affect product quality, such as steam, process gases, compressed air and HVAC, should be qualified, monitored, with action taken when limits are exceeded, and their drawings kept available. Ventilation, filtration and exhaust should be provided where needed and designed to minimise contamination and cross-contamination, controlling pressure, micro-organisms, dust, humidity and temperature as the stage requires, with special care where the API is exposed. Recirculated air needs measures against contamination. Fixed pipework should be identified by line labelling, documentation, computer control or other means and routed to avoid contaminating product. Drains should be adequately sized and fitted with an air break or anti-back-siphon device where appropriate.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.