Chromatography Skid Flow Meter (CAL-0311) – Calibration Documents

Calibration Documents: Chromatography Skid Flow Meter (CAL-0311)

Asset ID CAL-0311
Equipment Chromatography Skid Flow Meter
Equipment Type Flow Meter
Department Biologics
Area/Location Downstream
Process Use Flow
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 Chromatography Skid Flow Meter is performed to ensure accurate measurement of flow rates, which is critical for maintaining product quality and patient safety in the Biologics department. Accurate flow measurements help control the manufacturing process, thereby minimizing risks associated with batch quality and ensuring data integrity.

2. Scope

  • Asset ID: CAL-0311
  • Equipment Name/Type: Chromatography Skid Flow Meter / Flow Meter
  • Department/Area: Biologics / Downstream
  • Process Use: Flow
  • 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 specified standards.
  • As Found: The condition of the instrument prior to any adjustments.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement results fall outside the defined acceptance criteria.
  • Drift: The gradual change in the output of a measurement instrument over time.
  • Traceability: The ability to trace the history, application, or location of an item or activity through documented records.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A periodic check performed between calibrations to ensure continued accuracy of the instrument.

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 accessible for calibration.
  • External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment prior to calibration.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment to ensure accurate measurements.
  • Verify power supply stability before calibration.
See also  Bioreactor pH Probe (CAL-0301) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints across the range of 0 to 200 L/min. Each point will be measured in triplicate to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the flow meter to stabilize for a minimum of [TBD] minutes.
  3. As Found checks and data capture: Record initial measurements at each test point.
  4. Adjustment rules: If any measurement is OOT, follow the adjustment protocol; otherwise, escalate to QA.
  5. As Left verification: Confirm that all adjustments bring the instrument within acceptance criteria.
  6. Labeling + documentation completion: Ensure all calibration records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% of the measured value. The error calculation formula is as follows:

Error (%) = [(Measured Value – True Value) / True Value] x 100

Pass/Fail Logic: If the absolute error is within ±1%, the result is a pass; otherwise, it is a fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Review affected results/batches within the impact window of [TBD].
  • Recalibration after repair/adjustment: Ensure recalibration is performed before returning to service.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records in accordance with company policy.
  • 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 stabilized
  • Calibration tools ready
  • Documentation prepared

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

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See also  Hot Air Oven Temp Sensor (CAL-0154) - Calibration Documents

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-0311 Chromatography Skid Flow Meter Flow Meter Biologics Downstream Flow Flow L/min 0 – 200 ±1% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • 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 flow meter is clean and properly installed. Verify that all necessary tools and calibration standards are available.
  2. Stabilization: Allow the flow meter to stabilize for a minimum of [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point. Record all observed values.
  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: Complete the results table and ensure all data is recorded accurately, maintaining ALCOA+ principles.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

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

Approvals

Prepared By Reviewed By Approved By
____________________ / Date: ___________ ____________________ / Date: ___________ ____________________ / Date: ___________

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0311 Chromatography Skid Flow Meter Biologics Downstream Flow 0 – 200 L/min ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the equipment as per cleaning procedure
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries
See also  Refrigerator Temp Probe (2-8°C) (CAL-0190) - Calibration Documents

As Found Execution

  • [ ] Set flow meter to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review as per SOP

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary
  • Asset: Chromatography Skid Flow Meter
  • 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: [TBD]
  • 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

  • Investigation Summary Placeholders: [TBD]
  • 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-0311 Chromatography Skid Flow Meter Flow Meter Biologics Downstream [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) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (L/min) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: ______________________ Date: ____________

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