Risk Based Inspection (RBI) – Schedule M Point 4.26 asks the firm to “Specify the arrangement for preparation of pure steam & its use.” CDSCO In RBI, this is treated as a critical utility check because pure steam is commonly used for SIP of product-contact tanks/lines, sterilization support, and critical sanitation, so failure can create microbial/endotoxin contamination risk and weakens sterility assurance.
What “arrangement for preparation” should cover (what inspectors expect)
- Generation system (PSG) description
You should describe the Pure Steam Generator (PSG) and its feed source (normally WFI or suitably controlled feed water based on your design), the generation principle, and key engineered features (sanitary design, 316L product-contact parts, hygienic slopes, condensate management, traps, non-condensable vent, sampling points). RBI teams often record whether a PSG is provided as the basic compliance indicator for 4.26. - Distribution system
Provide the loop/line layout and controls: piping class/spec, insulation, trap stations, condensate return (or drain philosophy), pressure/temperature control, and how you prevent contamination during start-up and shutdown. Include P&ID references and status identification. - Defined uses (the “& its use” part)
List where pure steam is used (e.g., SIP of storage vessels, transfer lines, filters housings, CIP skids, etc.) and confirm the use points are qualified. RBI expects this mapping because the risk level changes depending on whether steam contacts product-contact surfaces or is only used for facility sanitation.
Evidence RBI typically reviews
- URS/DQ and P&IDs, installation drawings, and utility classification/risk assessment.
- Qualification package for PSG and distribution (IQ/OQ/PQ) and maintenance/calibration of instruments.
- Operating SOPs: start-up, blowdown, trap checks, condensate sampling, deviations/CAPA.
- Linkage to the next checklist controls: pure steam condensate quality meeting WFI specs and PQ verification of PSG (often reviewed together with 4.26).
Common RBI gaps
Vague “PSG available” statements without P&ID/use mapping, poor trap maintenance causing wet steam, missing qualification linkage, and no documented control of steam quality at worst-case use points.