Skip to content

Knowledge search

Read-only index · 5 systems

Search SOPs, maintenance records, deviations, batch records and lab results together. Answers are assembled only from the excerpts shown below; open any citation to read the source.

Index refreshed 08:40 UTC by Knowledge IndexerDocumentum · Maximo · Veeva Vault · DeltaV · LabWarePermissions applied at query time
Inspect batch record
Frame KNOW-01

Filters

System of record

System of record

GxP class

GxP class

Equipment tag

Equipment tag

Synthesized answer — every statement cited; verify before use

Query “feed-rate deviations after calibration PM-204” · grounded in 4 sources from the results below

Not a QA determination
  1. 1

    ObservationA prior feed-rate deviation, Q-DEV-019 on PM-201, followed a scheduled calibration in which the occlusion bed was reseated and slip verification was omitted; it was closed with a procedural root cause.

  2. 2

    ObservationIn the prior campaign, MES-26068 recorded feed flow 6.8% below setpoint for 52 min at Step 05.4 after tubing was reseated.

  3. 3

    ObservationPM-204 was calibrated on 2026-10-17 (CAL-3310, static test PASS); the dynamic slip test was deferred because the fixture was out for repair.

  4. 4

    ObservationSOP-UP-014 Rev 7 §7.2 requires a dynamic slip verification at operating RPM after any occlusion adjustment before return to GMP service.

Not found / gaps

  • No Maximo record of a completed dynamic slip test for PM-204 after CAL-3310 was found.
  • No source states whether the omitted slip test caused the MES-26073 droop. That is a hypothesis under INV-104, not an answer.
  • Historian data for T+182.0–182.7h (42 min) is missing and is not searchable.

2 results hidden: you lack access to Basel QMS

Matching records exist in the Basel Veeva Vault tenant. Titles and content are withheld; they are not used in the answer above.

8 results · ranked by term match

  • DocumentumGMP-criticalPM-204PM-201Effective 2026-03-02

    SOP-UP-014 Rev 7 §7.2 · Tubing seating and occlusion

    7.2 After any occlusion adjustment, the operator SHALL perform a dynamic slip verification at the operating RPM before returning the pump to GMP service. Record the gravimetric delivery over 5 minutes; acceptance ±3% of setpoint.
    sha256:e05a8c3f2d…7c2b19
  • Veeva Vault QMSGMPPM-201BR-UP-02Closed 2025-11-21

    Q-DEV-019 · Feed flow below setpoint after calibration (closed)

    Feed flow on BR-UP-02 PM-201 ran 9.6% below setpoint for 3.1 h after scheduled calibration CAL-2981. Occlusion bed reseated during calibration; slip verification omitted. Root cause: procedural (verification step not performed). CAPA-0412: add slip verification sign-off to SOP-UP-014 (implemented as Rev 7 §7.2).
    sha256:93526c13ac…41e3a4
  • Maximo CMMSGMPPM-2042026-10-17

    CAL-3310 · PM-204 gravimetric flow calibration

    ASSET=PM-204 PROC=CAL-FLOW-GRAV-02 DATE=2026-10-17T06:40Z AS_FOUND=16.21 mL/min AS_LEFT=16.92 mL/min SP=16.90 TOL=±3% RESULT=PASS TECH=D.Huang NOTE=static test only; dynamic slip test deferred (fixture FX-12 out for repair)
    sha256:42b493a2ee…3e8881Open record
  • DeltaV eBRGMP-criticalBR-UP-01PM-2042026-10-19

    eBR MES-26073 · Step 05.4 Bolus nutrient addition

    PHASE=05 STEP=05.4 STATE=RUNNING FEED_SP=16.90 mL/min FEED_PV=14.48 mL/min DEV=-14.3% OPERATOR=T.Reed ACK=YES
    sha256:5d17e4a90c…7e3a85Inspect batch record
  • Veeva Vault QMSGMPBR-UP-01PM-2042026-10-19

    Q-DEV-031 · Feed flow below setpoint, QA hold (open)

    Feed flow on BR-UP-01 fell below setpoint by >10% for 47 min during Phase 05. PM-204 head pressure exceeded 1.20 bar ceiling. Batch MES-26073 placed on QA hold pending investigation.
    sha256:91c4e0b7a2…4a7d03Open record
  • DeltaV eBRGMPBR-UP-01PM-2042026-05-08

    eBR MES-26068 · Step 05.4 exception E-2 (prior campaign)

    PHASE=05 STEP=05.4 EXCEPTION=E-2 FEED_PV below SP by 6.8% for 52 min; operator comment: "tubing reseated per SOP-UP-014 Rev 6 §7.2, flow recovered". QA_REVIEW=ACCEPTED
    sha256:846e1b14df…15aea3
  • Maximo CMMSGMPPM-2042026-10-17

    WO-8819 · PM-204 occlusion clamp torque adjustment

    PM-204 occlusion clamp torque adjusted from 0.42 N·m to 0.55 N·m per tech judgement after audible chatter. Dynamic slip verification not performed (fixture unavailable). Returned to service.
    sha256:3b9d71e0c4…9a2f60Open record
  • DocumentumNon-GxP referencePM-204PM-201Rev C · 2024

    Masterflex L/S pump head manual · Table 4 tubing service life

    Platinum-cured silicone, size 24: expected service life 400–500 h at ≤200 RPM. Increased occlusion shortens life and raises discharge pressure.
    sha256:0e7b3c19d5…b3c25f