Preparation operator
Reconcile additions, adjustments and mixing against the complete execution record.
Run buffer, media and feed preparation in Seal—from a versioned recipe to the containers your process uses. Keep actual additions, checks and use history connected.
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100 L preparation BM-01 / v03
Equipment, timing and protocol are recorded together. The technical review is still open.
Illustrative records. Selecting a stage inspects the example; it does not execute, verify or approve work.
The execution records 1.200 kg of dry-mix lot DM-024 and a final volume of 100 L, against BM-01 v03. Those are recorded values, not just the recipe targets. The preparation record stays linked to that recipe version.
The pH check is in range for this example, but the preparation review has no decision recorded. I’d check the full execution and the procedure’s remaining requirements before treating it as ready to issue.
Here’s a review draft with the execution and measurement sources attached. It leaves the issue decision with your reviewer; no status, label or approval has been changed.
The recorded quantities and pH can be checked. The issue decision remains open.
| Check | Required | Recorded |
|---|---|---|
| Dry-mix addition | 1.200 kg at 100 L | 1.200 kg / lot DM-024 |
| Final pH | 7.10–7.30 in this example | 7.18 at 22 °C |
| Mixing execution | Review against BM-01 v03 | MIX-081 / MX-02 / 09:20–09:40; technical review open |
| Issue decision | Completed preparation review | Not recorded |
Reconcile additions, adjustments and mixing against the complete execution record.
Review measurement context and identify any other checks the recipe requires.
Confirm storage and hold-time requirements, then record the authorised issue decision.
PREP-081
Its original quantities, lots and resultsAdd a conductivity check
Proposed. Method and range still to agree.Keep formulation version, material identity, grade and concentration basis together.
Distinguish a dry powder, a concentrated stock and a ready-to-use liquid. Record which values are mass, volume, concentration or activity, and preserve the source of any potency or moisture correction. Final solution volume is not automatically the initial water charge. Define rounding, tolerances and allowed adjustments in the protocol. When the formulation changes, retain the old preparation records against the version actually executed, rather than recalculating their history with a new recipe.
A proportional quantity calculation does not prove that a mixing process will transfer to another scale.
Keep the vessel or bag, working range, mixing method, order of addition, temperature, dissolution observations and any hold or conditioning steps with the protocol. PD defines the scientific intent; MSAT carries the rationale and remaining questions into transfer. Review local equipment and confirmation work before manufacturing use. The illustrated recipe calculates a dry-mix quantity for its stated final volume; it does not propose mixing speeds, times or process settings. Record which equipment and scale were actually assessed, which protocol version the evidence supports and which transfer questions remain open for the receiving team.
From an ingredient to its preparations. From a consuming run back to the container and recipe used.
Execute the preparation against the selected protocol and capture the values actually used.
Link source material containers, lot status, water source, balance readings and destination vessel to the preparation. Record adjustments as additions with an identity and amount, not just a final number that conceals how it was reached. Preserve interruptions, rework and observations. Confirm operator and equipment readiness under the procedure. Device connections need agreed units, timestamps and failure behaviour; a missing reading must not silently become the planned target or a retrospective pass.
Carry the preparation identity into storage, dispensing and the run that consumes it.
Link each container or aliquot to the parent preparation, quantity, storage condition, label and applicable expiry or in-use rule. Define when each clock starts and which event changes it. Record actual issue, return, waste and remaining quantity; distinguish a reservation from a physical transfer. If a preparation is questioned later, find the recorded consuming runs and unused containers without assuming every planned use occurred. Changes to status and physical movements should reconcile across the connected systems.
Connect pH, conductivity, osmolality or other specified checks to their method and measurement conditions.
Choose the checks appropriate to the actual buffer, medium or feed; not every preparation requires the same panel. Retain sample identity, instrument, calibration context, temperature where relevant, result and review. A retest or adjustment does not erase the original result. If filtration, sterilisation or other processing is required, record its execution and associated evidence separately. A favourable chemical result does not by itself establish microbial quality, sterility or suitability for a particular use.
Share the record structure without forcing the same process onto every preparation.
Buffers support purification and other process operations; culture media and feeds support upstream cultures. Retain the formulation-specific ingredients, sequence, processing, analytical requirements and use conditions. Purchased ready-to-use solutions still need receipt, storage and use traceability, but do not need a fictional in-house mixing record. Keep laboratory reagents and standards on their own qualification and value-assignment workflows. Configure reusable steps where appropriate while retaining the differences that matter to the actual preparation.
Keep specialised systems where they belong. Agree the source of each record, the permitted actions and the reconciliation at each handoff.
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