Autoclave Chart Recorder Temp (CAL-0220) – Calibration Documents

Calibration Documents: Autoclave Chart Recorder Temp (CAL-0220)

Asset ID CAL-0220
Equipment Autoclave Chart Recorder Temp
Equipment Type Chart Recorder
Department Microbiology/Sterile
Area/Location Sterilization
Process Use Recording
Parameter Temperature
Units °C
Range Min 100
Range Max 140
Acceptance Criteria ±0.5°C
Calibration Frequency (days) 180
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 Chart Recorder Temp is performed to ensure accurate temperature recording during sterilization processes. This is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Inaccurate temperature readings can lead to ineffective sterilization, posing risks to product safety and compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0220
  • Equipment Name/Type: Autoclave Chart Recorder Temp / Chart Recorder
  • Department/Area: Microbiology/Sterile / Sterilization
  • Process Use: Recording
  • Parameter: Temperature
  • Range: 100°C to 140°C
  • Units: °C
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
  • Verification: The process of confirming that an instrument meets specified requirements.
  • Adjustment: The act of altering an instrument to bring it into compliance with specified standards.
  • As Found: The condition of the instrument prior to any adjustments made during calibration.
  • As Left: The condition of the instrument after adjustments have been made during calibration.
  • OOT (Out of Tolerance): A condition where the measurement exceeds the defined acceptance criteria.
  • Drift: The gradual change in an instrument’s output over time.
  • Traceability: The property of a measurement result whereby it can be related to national or international standards.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is asserted to lie.
  • Intermediate Check: A verification process conducted between calibrations to ensure continued accuracy.

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 equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the calibration area and equipment.
  • Check that the equipment is level and stable.
  • Verify power supply is stable and within specifications.
See also  ICP-OES (CAL-0116) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

The calibration will follow an As Found then As Left logic. The minimum number of calibration points will be five, including endpoints (100°C and 140°C) and midpoints. Each point will have three replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the equipment to reach operating conditions.
  3. As Found checks and data capture: Record initial temperature readings at defined points.
  4. Adjustment rules: If any readings are OOT, escalate for adjustment as per SOP.
  5. As Left verification: Confirm that all adjustments bring the equipment within acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

Record raw observations contemporaneously to maintain ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Autoclave Chart Recorder Temp is ±0.5°C. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within 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 relevant personnel and initiate deviation process.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records of calibration certificates.
  • E-records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and 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
  • Calibration tools prepared
  • Documentation ready

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-0220 Autoclave Chart Recorder Temp Chart Recorder Microbiology/Sterile Sterilization Recording Temperature °C 100 – 140 ±0.5°C 180 days External ISO17025
See also  Karl Fischer Titrator (Coulometric) (CAL-0141) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Minimum: 100°C
  • 25% of Range: 110°C
  • 50% of Range: 120°C
  • 75% of Range: 130°C
  • Maximum: 140°C

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
100°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
110°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
120°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
130°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]
140°C [TBD] [TBD] [TBD] ±0.5°C [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the autoclave chart recorder is clean and operational. Verify that the calibration equipment is within its calibration date.
  2. Stabilization: Allow the equipment to stabilize at the ambient temperature for at least 30 minutes before performing readings.
  3. Performing Readings: Take readings at each test point in replicates of three. Record all observed values.
  4. Calculating Error: Calculate the error for each test point by subtracting the reference value from the observed value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.5°C.
  6. Documentation: Complete the results table with all observed values, errors, and pass/fail status.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance.
  • 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-0220 Autoclave Chart Recorder Temp Microbiology/Sterile Sterilization Temperature 100 – 140 °C ±0.5°C 180 days ISO17025

1) Pre-calibration

  • [ ] Verify environment conditions are within acceptable limits
  • [ ] Ensure equipment has warmed up properly
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

2) As Found Execution

  • [ ] Set the required temperature setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Fluorescence Spectrophotometer (CAL-0114) - Calibration Documents

3) OOT Immediate Actions

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

4) As Left Verification

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

5) 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 Accurate, Legible, Contemporaneous, Original, and Attributable.

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Deviation Impact Assessment

Event Summary
Asset: Autoclave Chart Recorder Temp
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

Investigation Summary Placeholders: [TBD]

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-0220 Autoclave Chart Recorder Temp Chart Recorder Microbiology/Sterile Sterilization [TBD] [TBD] [TBD] Temperature: 100 – 140 °C ±0.5°C

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

As Left Results

Test Point Measured Value (°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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