Header & Document Control
Establish the identity of this Master Batch Record.
Equipment & Line Clearance
Define equipment first so fill level decisions are meaningful.
Provenance tagged: “AI extract from screenshot – PE confirmed”.
Add sifters, bins, sample thieves, or other product-contact equipment used in this unit operation.
Materials / Bill of Materials
Define every component. Weigh-and-verify fields are reserved automatically (G6). Charge sequence is applied automatically (polymers/diluent first → API mid → glidant → lubricant last) or by explicit chargeSequence if provided.
Provenance tagged: “AI extract from screenshot – PE confirmed”.
Critical Process Parameters
Every critical parameter must carry Target + Lower + Upper (G3).
Provenance tagged: “AI extract from screenshot – PE confirmed”.
| Parameter | Target | Lower | Upper | Unit | Source |
|---|
Charging Sequence & Instructions
Ordered, imperative steps (preferred charge sequence applied automatically). High-risk decisions must be explicit. Document the rationale for the order below.
Blend Uniformity Hold Point
Enforce a hard hold before transfer to the next unit operation (G2). Discharge to quarantined containers may precede results; release for compression/encapsulation may not.
Provenance tagged: “AI extract from screenshot – PE confirmed”.
QU disposition required before transfer to the next unit operation is locked to Yes. Discharge under quarantine is permitted; release for compression/encapsulation is not.
Yield Reconciliation
Separate usable yield (product available for the next unit operation) from accountability (mass balance — everything must be accounted for). Both are required (G7).
Formula A – Usable Yield – (Actual usable quantity ÷ Theoretical) × 100. Trigger band: usable yield limits.
Formula B – Accountability – Mass balance (inputs vs outputs + accounted losses). Trigger band: accountability limits.
These are distinct. A batch can meet accountability and still fall outside usable yield (e.g. higher sampling / scrap).
Discharge, Identity & Hold Control
Control the intermediate after it leaves the blender (G8).
Review & Generate
Phase 3: Forced full preview + provenance attestation required before export.