Autoclave Timer (CAL-0152) – Calibration Documents

Calibration Documents: Autoclave Timer (CAL-0152)

Asset ID CAL-0152
Equipment Autoclave Timer
Equipment Type Timer
Department Microbiology
Area/Location Sterilization
Process Use Cycle time
Parameter Time
Units min
Range Min 0
Range Max 300
Acceptance Criteria ±1 min
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 Autoclave Timer (CAL-0152) is performed to ensure accurate measurement of cycle time, which is critical for maintaining sterilization processes. Accurate timing is essential to control risks associated with patient safety, batch quality, and data integrity in microbiological applications.

2. Scope

  • Asset ID: CAL-0152
  • Equipment Name/Type: Autoclave Timer / Timer
  • Department/Area: Microbiology / Sterilization
  • Process Use: Cycle time
  • Parameter: Time
  • Range: 0 – 300 min
  • Units: min
  • Calibration Frequency: 365 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 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 the measurement falls outside the specified 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 dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A periodic verification of an 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 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 equipment and surrounding area.
  • Verify that the equipment is level and stable.
  • Check power supply for proper voltage and stability.
See also  Potentiometric Titrator (CAL-0142) - 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 points: 5 points including endpoints (0 min, 150 min, 300 min).
  • Replicate readings: 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the Autoclave Timer to stabilize for [TBD] minutes.
  3. As Found checks and data capture: Record initial measurements.
  4. Adjustment rules: If OOT, adjust as per manufacturer specifications; if not allowed, escalate to QA.
  5. As Left verification: Confirm that the instrument is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the instrument accordingly.

Record raw observations contemporaneously to ensure ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1 min

Error calculation formula: Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within ±1 min, the calibration 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 affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration as needed.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records for audit purposes.
  • 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 stabilized
  • As Found data recorded
  • Adjustments made if necessary
  • As Left data recorded
  • Documentation completed

Annexure C: Example Label Text

Calibration Date: [TBD]

See also  Standard Weights Set F2 (CAL-0282) - 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-0152 Autoclave Timer Timer Microbiology Sterilization Cycle time Time min 0 – 300 ±1 min 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 min
  • 25% of Range: 75 min
  • 50% of Range: 150 min
  • 75% of Range: 225 min
  • Maximum: 300 min

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 min [TBD] [TBD] [TBD] ±1 min [TBD] [TBD] [TBD] [TBD]
75 min [TBD] [TBD] [TBD] ±1 min [TBD] [TBD] [TBD] [TBD]
150 min [TBD] [TBD] [TBD] ±1 min [TBD] [TBD] [TBD] [TBD]
225 min [TBD] [TBD] [TBD] ±1 min [TBD] [TBD] [TBD] [TBD]
300 min [TBD] [TBD] [TBD] ±1 min [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the autoclave timer is clean and in good working condition.
  2. Stabilization: Allow the equipment to stabilize for at least 30 minutes before calibration.
  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 to the acceptance criteria of ±1 min.
  6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • 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 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-0152 Autoclave Timer Microbiology Sterilization Time 0 – 300 min ±1 min 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions
  • [ ] Ensure equipment is warmed up
  • [ ] Clean the equipment
  • [ ] Level the equipment
  • [ ] Check reference standards validity
  • [ ] Ensure logbook is ready
See also  Autoclave Pressure Gauge (CAL-0151) - Calibration Documents

As Found Execution

  • [ ] Set initial time setpoints
  • [ ] Perform multiple repeats
  • [ ] Record raw data
  • [ ] Perform necessary calculations

OOT Immediate Actions

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

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm readings are within limits

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary
Asset: Autoclave Timer
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-0152 Autoclave Timer Timer Microbiology Sterilization [TBD] [TBD] [TBD] Time: 0 – 300 min ±1 min

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 (min) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measurement (min) 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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