Skid pH Sensor (CAL-0314) – Calibration Documents

Calibration Documents: Skid pH Sensor (CAL-0314)

Asset ID CAL-0314
Equipment Skid pH Sensor
Equipment Type pH Sensor
Department Biologics
Area/Location Downstream
Process Use pH
Parameter pH
Units pH
Range Min 1
Range Max 14
Acceptance Criteria ±0.05
Calibration Frequency (days) 180
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 Skid pH Sensor is performed to ensure accurate measurement of pH levels during the downstream processing of biologics. This calibration controls risks associated with accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0314
  • Equipment Name/Type: Skid pH Sensor / pH Sensor
  • Department/Area: Biologics / Downstream
  • Process Use: pH
  • Parameter: pH
  • Range: 1 to 14
  • Units: pH
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The act of modifying a measurement instrument to bring it into compliance with specified standards.
  • 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 results fall outside the defined 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 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 verification of the instrument’s performance 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 compliance with calibration schedules.
  • External Service Provider: Conduct external calibrations as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the pH sensor as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply stability.
See also  Pycnometer (Density bottle) (CAL-0046) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: Calibration standards for pH measurement.
  • Traceability Statement: Calibration traceability to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (1, 14) and midpoints (7).
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the pH sensor to stabilize as per manufacturer recommendations.
  3. As Found checks and data capture: Record initial readings at defined points.
  4. Adjustment rules: If OOT is found, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Record final readings after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out accurately.

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

10. Acceptance Criteria & Calculations

Acceptance criteria for the Skid pH Sensor is ±0.05 pH units.

Error Calculation Formula: Error = Observed Value – Reference Value

Pass/Fail Logic: If the absolute value of Error is within acceptance criteria, mark as Pass; otherwise, mark as Fail.

Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration as necessary.
  • 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 cleaned and leveled.
  • Power supply checked.
  • Calibration standards prepared.

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

See also  Volumetric Flask 100 mL (CAL-0035) - Calibration Documents

Status: [TBD]

⬆ Back to TOC

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-0314 Skid pH Sensor pH Sensor Biologics Downstream pH pH 1 – 14 ±0.05 180 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 1
  • 25%: 4
  • 50%: 7.5
  • 75%: 11
  • Maximum: 14

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
1 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
4 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
7.5 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
11 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
14 [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Skid pH Sensor is clean and free from contaminants.
  2. Stabilization: Allow the sensor to stabilize in the calibration solution for at least 30 minutes.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±0.05.
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

If any observed values fall 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 Reviewed Approved
[Signature/Date] [Signature/Date] [Signature/Date]

⬆ Back to TOC

Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0314 Skid pH Sensor Biologics Downstream pH 1 – 14 ±0.05 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the sensor as per cleaning procedure
  • [ ] Ensure the sensor is leveled correctly
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the pH sensor to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Micropipette Set (Micro Lab) (CAL-0242) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

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

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

⬆ Back to TOC

Deviation Impact Assessment

Event Summary
Asset: Skid pH 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: [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]

⬆ Back to TOC

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-0314 Skid pH Sensor pH Sensor Biologics Downstream [TBD] [TBD] [TBD] pH (1 – 14) ±0.05

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 Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: _____________________ Date: ____________

⬆ Back to TOC