Inline Flow Meter (Solvent) (CAL-0203) – Calibration Documents

Calibration Documents: Inline Flow Meter (Solvent) (CAL-0203)

Asset ID CAL-0203
Equipment Inline Flow Meter (Solvent)
Equipment Type Flow Meter
Department API
Area/Location Process Area
Process Use Solvent transfer
Parameter Flow
Units L/min
Range Min 0
Range Max 200
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 Inline Flow Meter (Solvent) is performed to ensure accurate measurement of solvent transfer within the API process area. This calibration controls risks associated with accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0203
  • Equipment Name/Type: Inline Flow Meter (Solvent) / Flow Meter
  • Department/Area: API / Process Area
  • Process Use: Solvent transfer
  • Parameter: Flow
  • Range: 0 – 200 L/min
  • Units: L/min
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: The confirmation that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement instrument to bring it into compliance with specifications.
  • As Found: The condition of the instrument prior to calibration.
  • As Left: The condition of the instrument after calibration.
  • 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 trace the history, application, or location of an item through documented recorded identification.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A verification process conducted between calibrations to ensure ongoing accuracy.

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 for compliance.
  • Owner Department: Ensure equipment is available and accessible for calibration.
  • External Service Provider: Conduct external calibration as per the defined schedule.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment warm-up/stabilization time as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Verify equipment is level and stable.
  • Check power supply for proper voltage and stability.

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: Ensure all calibration certificates are current and valid.
  • Standard ID placeholders: [TBD]
See also  Autoclave Timer (CAL-0152) - Calibration Documents

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0 and 200 L/min) and midpoints.
  • Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Inline Flow Meter to stabilize before taking measurements.
  3. As Found checks and data capture: Record initial readings and document all observations contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is detected, follow adjustment protocols if allowed; otherwise, escalate to QA.
  5. As Left verification: Confirm that the instrument is within specifications after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment appropriately.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1%

Error calculation formula: Error (%) = (Measured Value – True Value) / True Value × 100

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration is considered a pass; otherwise, it is a fail.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use until resolved.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed after any adjustments.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain records of calibration reports and certificates.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and 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 checked

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-0203 Inline Flow Meter (Solvent) Flow Meter API Process Area Solvent transfer Flow L/min 0 – 200 ±1% 365 days External ISO17025
See also  Platform Scale 600 kg (CAL-0006) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for calibration will be selected as follows:

  • Minimum: 0 L/min
  • 25% of Range: 50 L/min
  • 50% of Range: 100 L/min
  • 75% of Range: 150 L/min
  • Maximum: 200 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]
50 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
100 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
150 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
200 L/min [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Inline Flow Meter is clean and free from any obstructions. Verify that the equipment is calibrated within the specified frequency.
  2. Stabilization: Allow the equipment 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 using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±1%.
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the Inline Flow Meter.
  • Notify the QA department immediately.
  • 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-0203 Inline Flow Meter (Solvent) API Process Area Flow 0 – 200 L/min ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has been warmed up for the required time
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready and accessible

As Found Execution

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

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance
  • [ ] Stop use of the equipment immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP
See also  Water System Temperature Sensor (CAL-0320) - Calibration Documents

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all results are within acceptance limits

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Inline Flow Meter (Solvent)
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 service
  • Segregate impacted work

Define Impact Window

Last known in-tolerance date: [TBD] to discovery date: [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-0203 Inline Flow Meter (Solvent) Flow Meter API Process Area [TBD] [TBD] [TBD] Flow: 0 – 200 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 [TBD] ±1% [TBD]
50 [TBD] ±1% [TBD]
100 [TBD] ±1% [TBD]
150 [TBD] ±1% [TBD]
200 [TBD] ±1% [TBD]

As Left Results

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

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [TBD]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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