Friability Tester (CAL-0134) – Calibration Documents

Calibration Documents: Friability Tester (CAL-0134)

Asset ID CAL-0134
Equipment Friability Tester
Equipment Type Friability Tester
Department QC
Area/Location Instrument Room
Process Use Friability
Parameter Speed
Units RPM
Range Min 0
Range Max 100
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 Friability Tester (Asset ID: CAL-0134) is performed to ensure accurate measurement of the friability parameter, which is critical for maintaining batch quality and patient safety. Accurate calibration mitigates risks associated with inaccurate readings that could lead to compromised product integrity and data integrity.

2. Scope

  • Asset ID: CAL-0134
  • Equipment Name/Type: Friability Tester
  • Department/Area: QC, Instrument Room
  • Process Use: Friability
  • Parameter: Speed
  • Range: 0 – 100 RPM
  • Units: RPM
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a known 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 specifications.
  • 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 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 that characterizes the range of values within which the true value of a measurement lies.
  • Intermediate Check: A periodic check 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 document results.
  • QC/QA Reviewer: Review calibration results and ensure compliance.
  • Owner Department: Ensure equipment is available and maintained.
  • External Service Provider: Conduct external calibration as per requirements.

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.
  • Check leveling of the equipment.
  • Verify power supply stability and functionality.
See also  Dry Heat Sterilizer Temp Sensor (CAL-0153) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

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

  • Minimum number of test points: 5 points including endpoints (0 RPM, 100 RPM) and midpoints (50 RPM).
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Friability Tester to warm up for [TBD] minutes.
  3. As Found checks and data capture: Record initial readings at all test points.
  4. Adjustment rules: If OOT is identified, follow the adjustment protocol; 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 and raw observations are recorded contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the Friability Tester is ±1% of the set point. The error calculation formula is:

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

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

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 of 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: Retain all calibration certificates.
  • 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
  • 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]

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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-0134 Friability Tester Friability Tester QC Instrument Room Friability Speed RPM 0 – 100 ±1% 365 days External ISO17025
See also  Balance Calibration Weight 200 g (CAL-0337) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 RPM
  • 25% of Range: 25 RPM
  • 50% of Range: 50 RPM
  • 75% of Range: 75 RPM
  • Maximum: 100 RPM

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 RPM [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
25 RPM [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
50 RPM [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
75 RPM [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
100 RPM [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Friability Tester is clean and free from any previous calibration residues.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before calibration.
  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 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]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0134 Friability Tester QC Instrument Room Speed 0 – 100 RPM ±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
  • [ ] Ensure equipment is leveled
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set the equipment to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  UPLC System (CAL-0121) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation
  • [ ] Trigger impact review

As Left Verification

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

Documentation & Closure

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

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate, with additional focus on Completeness and Consistency.

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Deviation Impact Assessment

Event Summary Details
Asset Friability Tester (CAL-0134)
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

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-0134 Friability Tester Friability Tester QC Instrument Room [TBD] [TBD] [TBD] Speed: 0 – 100 RPM ±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 (RPM) Acceptance Criteria Conformance
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 (RPM) Acceptance Criteria Conformance
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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