Tablet Press Thickness Sensor (CAL-0211) – Calibration Documents

Calibration Documents: Tablet Press Thickness Sensor (CAL-0211)

Asset ID CAL-0211
Equipment Tablet Press Thickness Sensor
Equipment Type Thickness Sensor
Department Production
Area/Location Compression
Process Use Thickness control
Parameter Thickness
Units mm
Range Min 0
Range Max 10
Acceptance Criteria ±0.05
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 Tablet Press Thickness Sensor is performed to ensure accurate measurement of tablet thickness, which is critical for maintaining product quality, patient safety, and compliance with regulatory standards. Proper calibration mitigates risks associated with inaccurate measurements that could lead to batch failures or compromised product integrity.

2. Scope

  • Asset ID: CAL-0211
  • Equipment Name/Type: Tablet Press Thickness Sensor / Thickness Sensor
  • Department/Area: Production / Compression
  • Process Use: Thickness control
  • Parameter: Thickness
  • Range: 0 mm to 10 mm
  • Units: mm
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a standard to determine its accuracy.
  • 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 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 defined acceptance criteria.
  • Drift: The gradual change in the measurement accuracy of an instrument 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 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 maintain records.
  • QC/QA Reviewer: Review calibration records and ensure compliance.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibrations as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm-up/stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is properly leveled.
  • Verify power supply is stable and meets equipment requirements.
See also  Stability Chamber Temp Probe (CAL-0180) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

The calibration will follow an As Found and As Left logic:

  • Minimum of 5 measurement points will be taken across the range (0 mm to 10 mm), including endpoints and midpoints.
  • Each point will have 3 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 equipment to stabilize in the calibration environment.
  3. As Found checks and data capture: Measure thickness at defined points and record raw observations contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is detected, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left verification: Measure again to confirm adjustments are within acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Tablet Press Thickness Sensor is ±0.05 mm.

Error Calculation Formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is less than or equal to the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Notify QA and initiate deviation process.
  • 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 include calibration date, due date, technician name, and status.
  • Calibration report/certificate filing must be maintained for audit purposes.
  • E-records if applicable: [TBD]

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]

See also  Multimeter (CAL-0270) - Calibration Documents

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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-0211 Tablet Press Thickness Sensor Thickness Sensor Production Compression Thickness control Thickness mm 0 – 10 ±0.05 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Min: 0 mm
  • 25%: 2.5 mm
  • 50%: 5 mm
  • 75%: 7.5 mm
  • Max: 10 mm

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mm [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
2.5 mm [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
5 mm [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
7.5 mm [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]
10 mm [TBD] [TBD] [TBD] ±0.05 [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the calibration environment is stable and the equipment is clean.
  2. Stabilization: Allow the thickness sensor to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate measurements at each test point and record the values.
  4. Calculating Error: Calculate the error for each test point using the formula: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.05 mm.
  6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

If any measurement 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 on further actions.

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-0211 Tablet Press Thickness Sensor Production Compression Thickness 0 – 10 mm ±0.05 mm 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the sensor and surrounding area
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the thickness sensor to specified setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Inline Temp Sensor (Reactor Jacket) (CAL-0200) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with calibration date
  • [ ] Attach calibration certificate to logbook
  • [ ] 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
Asset: Tablet Press Thickness 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]

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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-0211 Tablet Press Thickness Sensor Thickness Sensor Production Compression [TBD] [TBD] [TBD] Thickness: 0 – 10 mm ±0.05

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measurement (mm) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measurement (mm) 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: __________

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