Ultrafiltration TMP Sensor (CAL-0310) – Calibration Documents

Calibration Documents: Ultrafiltration TMP Sensor (CAL-0310)

Asset ID CAL-0310
Equipment Ultrafiltration TMP Sensor
Equipment Type TMP Sensor
Department Biologics
Area/Location Downstream
Process Use Pressure
Parameter Differential Pressure
Units bar
Range Min 0
Range Max 5
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 Ultrafiltration TMP Sensor is performed to ensure accurate measurement of differential pressure within the specified range. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby supporting compliance with regulatory requirements and maintaining the integrity of biologics manufacturing processes.

2. Scope

  • Asset ID: CAL-0310
  • Equipment Name/Type: Ultrafiltration TMP Sensor / TMP Sensor
  • Department/Area: Biologics / Downstream
  • Process Use: Pressure
  • Parameter: Differential Pressure
  • Range: 0 – 5 bar
  • Units: bar
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
  • Verification: The process of confirming that an instrument is functioning correctly.
  • Adjustment: The act of altering a measurement instrument to bring it into alignment with a standard.
  • As Found: The condition of the instrument prior to any adjustments being made.
  • As Left: The condition of the instrument 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 an 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 associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurement.
  • Intermediate Check: A periodic check performed to ensure that the instrument remains within specified limits between calibrations.

4. References

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

5. Responsibilities

  • Technician/Metrology: Perform calibration and maintain records.
  • QC/QA Reviewer: Review calibration results and documentation.
  • Owner Department: Ensure equipment is available and accessible 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 instrument as per manufacturer specifications.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the instrument.
  • Verify power supply stability and functionality.
See also  Stability Chamber Controller Display RH (CAL-0183) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: Ensure all reference standards are within their validity period.
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints within the specified range of 0 to 5 bar. It is recommended to take three replicate readings at each point to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the TMP Sensor to stabilize as per manufacturer recommendations.
  3. As Found checks and data capture: Record initial readings and conditions before any adjustments.
  4. Adjustment rules: If OOT is detected, follow adjustment protocols if allowed; otherwise, escalate the issue.
  5. As Left verification: Confirm that the instrument is functioning within specifications after adjustments.
  6. Labeling + documentation completion: Ensure all calibration records are filled out accurately and contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

The acceptance criteria for the Ultrafiltration TMP Sensor is ±1%. The error calculation formula is:

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

Pass/Fail logic: If the calculated error falls within the acceptance criteria, the calibration is deemed acceptable. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel 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 post-adjustment.
  • 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 clean and leveled
  • Power supply checked
  • Calibration standards available
See also  UV-Vis Spectrophotometer (CAL-0110) - Calibration Documents

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-0310 Ultrafiltration TMP Sensor TMP Sensor Biologics Downstream Pressure Differential Pressure bar 0 – 5 ±1% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Min: 0 bar
  • 25%: 1.25 bar
  • 50%: 2.5 bar
  • 75%: 3.75 bar
  • Max: 5 bar

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
1.25 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
2.5 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
3.75 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
5 bar [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Ultrafiltration TMP Sensor is clean and properly installed.
  2. Stabilization: Allow the sensor to stabilize for at least [TBD] minutes before taking readings.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading 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 in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

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

Approvals

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

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0310 Ultrafiltration TMP Sensor Biologics Downstream Differential Pressure 0 – 5 bar ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up adequately
  • [ ] Clean the sensor and surrounding area
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the initial setpoints for calibration
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Manometer (U-tube/Digital) (CAL-0078) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the relevant personnel
  • [ ] Document the deviation
  • [ ] Trigger impact review process

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm that all parameters are within specified limits

Documentation & Closure

  • [ ] Update equipment label with calibration details
  • [ ] Attach calibration certificate to documentation
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date for calibration

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

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Deviation Impact Assessment

Event Summary Details
Asset Ultrafiltration TMP Sensor
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

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-0310 Ultrafiltration TMP Sensor TMP Sensor Biologics Downstream [TBD] [TBD] [TBD] Differential Pressure (0 – 5 bar) ±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 (bar) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (bar) 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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