Tablet Hardness Tester (CAL-0132) – Calibration Documents

Calibration Documents: Tablet Hardness Tester (CAL-0132)

Asset ID CAL-0132
Equipment Tablet Hardness Tester
Equipment Type Hardness Tester
Department QC
Area/Location Instrument Room
Process Use Hardness
Parameter Force
Units N
Range Min 0
Range Max 500
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 Tablet Hardness Tester is performed to ensure accurate measurement of force applied during hardness testing. This calibration controls risks associated with inaccurate readings that could compromise patient safety, affect batch quality, and undermine data integrity.

2. Scope

  • Asset ID: CAL-0132
  • Equipment Name/Type: Tablet Hardness Tester / Hardness Tester
  • Department/Area: QC / Instrument Room
  • Process Use: Hardness
  • Parameter: Force
  • Range: 0 – 500 N
  • Units: N
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a standard to determine its accuracy.
  • Verification: The process of confirming 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 specified acceptance criteria.
  • Drift: The gradual change in the output of a measurement 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 dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A 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 records and ensure compliance.
  • Owner Department: Ensure the equipment is available for calibration.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer guidelines.
  • Maintain cleanliness of the instrument and surrounding area.
  • Verify that the instrument is level before calibration.
  • Check power supply and connections prior to use.
See also  Stability Chamber RH Probe (CAL-0181) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: Calibration is traceable to ISO17025.
  • Certificate Validity Check: Ensure all certificates are current and valid.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints within the range of 0 to 500 N. It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Tablet Hardness Tester to warm up as per manufacturer specifications.
  3. As Found checks and data capture: Measure the force at designated points and record raw observations contemporaneously (ALCOA+).
  4. Adjustment rules: If any measurements are OOT, escalate to the appropriate personnel for adjustment.
  5. As Left verification: After adjustments, recheck the measurements to ensure compliance.
  6. Labeling + documentation completion: Complete all required documentation and label the instrument with calibration details.

10. Acceptance Criteria & Calculations

The acceptance criteria for the Tablet Hardness Tester is ±1%. The error calculation formula is:

Error (%) = (Measured Value – True Value) / True Value * 100

Pass/Fail Logic: If the error is within ±1%, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • 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 post-adjustment.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries must be made for each calibration event.
  • Calibration report/certificate filing must be maintained.
  • E-records if applicable: [TBD]
  • Label content requirements: calibrated date, due date, by whom, 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
  • Instrument warm-up completed
  • Cleanliness checked
  • Leveling confirmed
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

See also  Autoclave Temp Sensor (CAL-0150) - Calibration Documents

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-0132 Tablet Hardness Tester Hardness Tester QC Instrument Room Hardness Force N 0 – 500 ±1% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 N
  • 25% of Range: 125 N
  • 50% of Range: 250 N
  • 75% of Range: 375 N
  • Maximum: 500 N

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 N [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
125 N [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
250 N [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
375 N [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
500 N [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Tablet Hardness Tester is clean and free from any obstructions.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before calibration.
  3. Performing Readings: Take three replicate measurements 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 ±1%.
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

In the event of an Out of Tolerance (OOT) condition:

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • 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-0132 Tablet Hardness Tester QC Instrument Room Force 0 – 500 N ±1% 365 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set the initial measurement setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Inline Conductivity Sensor (PW) (CAL-0094) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the QA department
  • [ ] Document the deviation
  • [ ] 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 details
  • [ ] Attach calibration certificate to records
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in the logbook

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Deviation Impact Assessment

Event Summary
Asset: Tablet Hardness Tester
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-0132 Tablet Hardness Tester Hardness Tester QC Instrument Room [TBD] [TBD] [TBD] Force: 0 – 500 N ±1%

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (N) Acceptance Criteria Pass/Fail
1 [TBD] ±1% [TBD]
2 [TBD] ±1% [TBD]
3 [TBD] ±1% [TBD]
4 [TBD] ±1% [TBD]
5 [TBD] ±1% [TBD]

As Left Results

Test Point Measured Value (N) Acceptance Criteria Pass/Fail
1 [TBD] ±1% [TBD]
2 [TBD] ±1% [TBD]
3 [TBD] ±1% [TBD]
4 [TBD] ±1% [TBD]
5 [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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