Guide6.1
Workflow overview
| Phase | Key controls | Record |
|---|---|---|
| Pre-operation | Hygiene and PPE; room clean; equipment clean, dry and labelled; line clearance | Checklist, logbook |
| Documentation | BMR reviewed and approved; raw materials requested | BMR |
| Material verification | Identity, QA RELEASED status, expiry, packaging | BMR |
| Environment & approval | Temperature and RH in specification; supervisor approval | BMR |
| Dispensing | One material at a time; second-person check; tags | Dispensing record |
| Sieving & inspection | Mesh integrity before and after; foreign matter check | BMR |
| Blending | Blender clean and dry; BMR sequence; validated time and speed | BMR |
| Mid-blend addition | Blender stopped; lubricant added per BMR; restart | BMR |
| Uniformity & approval | Visual check (and testing where required); supervisor approval | BMR |
| Discharge & filling | Lined, labelled drums; slow discharge; weigh each drum | BMR, labels |
| Sampling & testing | QA samples; moisture and density | IPC record |
| Release & transfer | Documents complete; QA release; warehouse transfer | BMR, transfer record |
| Cleaning & close-out | Clean, verify (visual, ATP, conductivity), final room check | Cleaning records |
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