Flow Meter (WFI Loop) (CAL-0081) – Calibration Documents

Calibration Documents: Flow Meter (WFI Loop) (CAL-0081)

Asset ID CAL-0081
Equipment Flow Meter (WFI Loop)
Equipment Type Flow Meter
Department Utilities
Area/Location WFI System
Process Use Flow monitoring
Parameter Flow
Units L/min
Range Min 0
Range Max 500
Acceptance Criteria ±1%
Calibration Frequency (days) 365
Calibration Type External
Traceability ISO17025

Table of Contents

  1. Calibration SOP
  2. Calibration Protocol
  3. Calibration Checklist
  4. Deviation Impact Assessment
  5. Calibration Certificate

Calibration SOP

1. Purpose

The calibration of the Flow Meter (WFI Loop) is performed to ensure accurate flow monitoring within the WFI system. This calibration controls risks associated with inaccurate flow measurements that could compromise patient safety, batch quality, and overall data integrity.

2. Scope

  • Asset ID: CAL-0081
  • Equipment Name/Type: Flow Meter (WFI Loop) / Flow Meter
  • Department/Area: Utilities / WFI System
  • Process Use: Flow monitoring
  • Parameter: Flow
  • Range: 0 – 500 L/min
  • Units: L/min
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement instrument to bring it into alignment with a standard.
  • As Found: The condition of the equipment prior to any adjustments being made.
  • As Left: The condition of the equipment after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in a measurement instrument’s output over time.
  • Traceability: The ability to verify the history, location, or application of an item by means of documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is asserted to lie.
  • Intermediate Check: A quick verification of the instrument’s performance between full calibrations.

4. References

  • Company Metrology SOP [TBD]
  • ISO/IEC 17025 traceability via calibration certificates
  • ALCOA+ principles

5. Responsibilities

  • Technician/Metrology: Perform calibration and document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer specifications.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply is stable and within specifications.
See also  Micropipette 2-20 µL (CAL-0021) - Calibration Documents

7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure calibration certificates are current and valid.

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of test points will be five, including endpoints and midpoints. Each point will have three replicate readings taken as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the flow meter to stabilize as per the manufacturer’s guidelines.
  3. As Found checks and data capture: Record initial readings at defined test points.
  4. Adjustment rules: If OOT is found, escalate for adjustment as per SOP.
  5. As Left verification: Confirm that the flow meter is within specifications after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record all raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the Flow Meter (WFI Loop) is ±1%. The error calculation formula is:

Error (%) = ((Observed Value – True Value) / True Value) * 100

Pass/Fail logic: If the error is within ±1%, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries must be completed for each calibration.
  • Calibration report/certificate filing must be maintained.
  • E-records if applicable: [TBD]
  • Label content requirements: calibrated date, due date, by whom, status.

13. Annexures

Annexure A: Calibration Data Sheet

Test Points Reference Observed Error Acceptance Pass/Fail As Found As Left
[TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Annexure B: Quick Checklist

  • Environmental controls verified
  • Equipment warm-up completed
  • Cleanliness checked
  • Leveling confirmed
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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Calibration Protocol

Calibration Protocol

Protocol ID Asset ID Equipment Name Equipment Type Dept Area Process Use Parameter Units Range Acceptance Criteria Frequency Calibration Type Traceability
[TBD] CAL-0081 Flow Meter (WFI Loop) Flow Meter Utilities WFI System Flow monitoring Flow L/min 0 – 500 ±1% 365 days External ISO17025
See also  Differential Pressure Gauge 0-250 Pa (CAL-0076) - Calibration Documents

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 L/min
  • 25% of Range: 125 L/min
  • 50% of Range: 250 L/min
  • 75% of Range: 375 L/min
  • Maximum: 500 L/min

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
125 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
250 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
375 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
500 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the flow meter is clean and properly installed in the WFI loop.
  2. Stabilization: Allow the system to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors to the acceptance criteria of ±1%.
  6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

If any observed value is out of tolerance (OOT):

  • Stop use of the flow meter immediately.
  • Notify the QA department.
  • Open a deviation report.
  • Quarantine impacted results window: [TBD]
  • Await QA decision on further actions.

Approvals

Prepared By Reviewed By Approved By
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0081 Flow Meter (WFI Loop) Utilities WFI System Flow 0 – 500 L/min ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure flow meter has warmed up adequately
  • [ ] Clean the flow meter as per SOP
  • [ ] Level the flow meter if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set flow meter to specified setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the flow meter if out of tolerance
  • [ ] Stop use of the flow meter immediately
  • [ ] Notify relevant personnel of the OOT condition
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP
See also  Dew Point Meter (CAL-0062) - Calibration Documents

As Left Verification

  • [ ] Conduct post-adjustment checks to confirm accuracy
  • [ ] Ensure all measurements are within acceptance limits

Documentation & Closure

  • [ ] Update calibration label with new date
  • [ ] Attach calibration certificate to logbook
  • [ ] Obtain reviewer sign-off on calibration results
  • [ ] Update next due date in the logbook

Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, and Accurate.

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Deviation Impact Assessment

Event Summary Details
Asset Flow Meter (WFI Loop)
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use of the asset
  • Label/tag the asset as out of tolerance
  • Segregate impacted work

Define Impact Window

Last Known In-Tolerance Date Discovery Date
[TBD] [TBD]

Product/Batch/Test Impact Review

Batch/Study/Report ID Results Potentially Impacted Re-test/Re-weigh Decision
[TBD] [TBD] [TBD]

Data Integrity Review Prompts (ALCOA+)

  • Attributable: [TBD]
  • Legible: [TBD]
  • Contemporaneous: [TBD]
  • Original: [TBD]
  • Accurate: [TBD]
  • Complete: [TBD]
  • Consistent: [TBD]
  • Enduring: [TBD]
  • Available: [TBD]

Risk Assessment

Severity Probability Detectability Rationale Overall Risk
[TBD] [TBD] [TBD] [TBD] [TBD]

Investigation Summary

Root Cause: [TBD]

CAPA Plan

Action Owner Due Date Effectiveness Check
[TBD] [TBD] [TBD] [TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

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Calibration Certificate

Certificate No: [TBD]

Date: [TBD]

Next Due Date: [TBD]

Asset Details

Asset ID Equipment Name Equipment Type Dept Area Make/Model Serial No Location Parameter/Range/Units Acceptance Criteria
CAL-0081 Flow Meter (WFI Loop) Flow Meter Utilities WFI System [TBD] [TBD] [TBD] Flow: 0 – 500 L/min ±1%

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] ISO17025

Results

As Found Results

Test Point Measured Value (L/min) Acceptance Criteria Pass/Fail
0 L/min [TBD] ±1% [TBD]
100 L/min [TBD] ±1% [TBD]
200 L/min [TBD] ±1% [TBD]
300 L/min [TBD] ±1% [TBD]
400 L/min [TBD] ±1% [TBD]

As Left Results

Test Point Measured Value (L/min) Acceptance Criteria Pass/Fail
0 L/min [TBD] ±1% [TBD]
100 L/min [TBD] ±1% [TBD]
200 L/min [TBD] ±1% [TBD]
300 L/min [TBD] ±1% [TBD]
400 L/min [TBD] ±1% [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: ______________________ Date: ____________

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