Calibration Documents: Disintegration Tester (CAL-0131)

Asset ID	CAL-0131
Equipment	Disintegration Tester
Equipment Type	Disintegration Tester
Department	QC
Area/Location	Instrument Room
Process Use	Disintegration
Parameter	Temperature
Units	°C
Range Min	20
Range Max	50
Acceptance Criteria	±0.5°C
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Disintegration Tester (Asset ID: CAL-0131) is performed to ensure accurate measurement of temperature during the disintegration process. This is critical for maintaining patient safety, ensuring batch quality, and upholding data integrity. Accurate temperature readings help prevent deviations that could affect product efficacy and safety.

2. Scope

Asset ID: CAL-0131
Equipment Name/Type: Disintegration Tester
Department/Area: QC, Instrument Room
Process Use: Disintegration
Parameter: Temperature
Range: 20°C to 50°C
Units: °C
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.
• As Left: The condition of the instrument after adjustments have been made.
• OOT (Out of Tolerance): A condition where a 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 range of values within which the true value is asserted to lie.
• 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 schedule.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm up and stabilize as per manufacturer’s instructions.
• Maintain cleanliness of the instrument and surrounding area.
• Check that the instrument is level and properly positioned.
• Verify power supply is stable and within specifications.

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including the endpoints (20°C and 50°C) and midpoints. Each point should have three replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and documentation.
2. Stabilization: Allow the Disintegration Tester to stabilize at the operating temperature range.
3. As Found checks and data capture: Measure temperature at specified points and record results contemporaneously.
4. Adjustment rules: If any readings are OOT, follow the adjustment protocol; if adjustments are not permissible, escalate to QA.
5. As Left verification: Re-measure to confirm that the instrument is within acceptance criteria after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the instrument with calibration details.

10. Acceptance Criteria & Calculations

Acceptance Criteria: ±0.5°C
Error Calculation Formula: Error = Observed Value – True Value
Pass/Fail Logic: If the error falls within the acceptance criteria, 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 deviation process.
• Impact assessment trigger: Define the impact window and review all affected results/batches.
• Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
• QA disposition placeholders: [TBD]

12. Records & Retention

Maintain logbook entries, calibration report/certificate filing, and e-records if applicable [TBD].
Label Content Requirements: Calibrated date, due date, technician name, and calibration status.

13. Annexures

Annexure A: Calibration Data Sheet (test points, reference, observed, error, acceptance, pass/fail; include As Found + As Left columns)
Annexure B: Quick checklist
Annexure C: Example label text (with [TBD] placeholders)

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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-0131	Disintegration Tester	Disintegration Tester	QC	Instrument Room	Disintegration	Temperature	°C	20 – 50	±0.5°C	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 20°C
• 25%: 27.5°C
• 50%: 35°C
• 75%: 42.5°C
• Maximum: 50°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
20°C	20°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
27.5°C	27.5°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
35°C	35°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
42.5°C	42.5°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
50°C	50°C	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the Disintegration Tester is clean and calibrated prior to use.
2. Stabilization: Allow the equipment to stabilize at the ambient temperature for at least 30 minutes.
3. Performing Readings:
   • Set the Disintegration Tester to the first test point.
   • Take three replicate readings for each test point.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated error against the acceptance criteria.
6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the Quality Assurance (QA) department.
• Open a deviation report.
• Quarantine impacted results window: [TBD]
• Await QA decision on further actions.

Approvals

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

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0131	Disintegration Tester	QC	Instrument Room	Temperature	20 – 50 °C	±0.5°C	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Ensure equipment has warmed up adequately
• [ ] Clean the equipment as per SOP
• [ ] Level the equipment if necessary
• [ ] Confirm reference standards are valid and calibrated
• [ ] Ensure logbook is ready for documentation

As Found Execution

• [ ] Set temperature setpoints
• [ ] Perform repeat measurements as required
• [ ] Record raw data accurately
• [ ] Perform necessary calculations for results

OOT Immediate Actions

• [ ] Tag out the equipment
• [ ] Stop use of the equipment
• [ ] Notify the appropriate personnel
• [ ] Document deviation from acceptance criteria
• [ ] Trigger impact review as necessary

As Left Verification

• [ ] Conduct post-adjustment checks
• [ ] Confirm all measurements 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

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Deviation Impact Assessment

Event Summary
Asset: Disintegration Tester Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the equipment
• Label/tag the equipment as out of service
• 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-0131	Disintegration Tester	Disintegration Tester	QC	Instrument Room	[TBD]	[TBD]	[TBD]	Temperature: 20 – 50 °C	±0.5°C

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

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

As Left Results

Test Point	Measurement (°C)	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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