Dry Heat Sterilizer Temp Sensor (CAL-0153) – Calibration Documents

Calibration Documents: Dry Heat Sterilizer Temp Sensor (CAL-0153)

Asset ID CAL-0153
Equipment Dry Heat Sterilizer Temp Sensor
Equipment Type Dry Heat Sterilizer
Department Microbiology
Area/Location Sterilization
Process Use Depyrogenation
Parameter Temperature
Units °C
Range Min 150
Range Max 300
Acceptance Criteria ±1°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 Dry Heat Sterilizer Temperature Sensor (CAL-0153) is performed to ensure accurate temperature measurements during the depyrogenation process. This calibration controls risks associated with patient safety, batch quality, and data integrity by ensuring that the equipment operates within specified limits.

2. Scope

  • Asset ID: CAL-0153
  • Equipment Name/Type: Dry Heat Sterilizer Temp Sensor / Dry Heat Sterilizer
  • Department/Area: Microbiology / Sterilization
  • Process Use: Depyrogenation
  • Parameter: Temperature
  • Range: 150°C to 300°C
  • Units: °C
  • Calibration Frequency: Every 180 days

3. Definitions

  • Calibration: The process of determining the accuracy of a measurement device by comparing it to a known standard.
  • Verification: The process of confirming that a measurement device meets specified requirements.
  • Adjustment: The process of altering a measurement device to bring it into compliance with specified standards.
  • As Found: The condition of the equipment prior to any adjustments being made.
  • As Left: The condition of the equipment after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement falls outside the established acceptance criteria.
  • Drift: The gradual change in the accuracy of a measurement device 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 performed 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • 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 guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and properly positioned.
  • Verify power supply is stable and within specifications.
See also  pH Meter Portable (CAL-0091) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

The calibration will follow the As Found and As Left logic. A minimum of 5 measurement points will be taken, including endpoints (150°C and 300°C) and midpoints. Each point will have 3 replicate readings to ensure accuracy.

9. Step-by-Step Procedure

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

Record all raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1°C from the target temperature. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail logic: If the absolute value of the error is within acceptance criteria, the result is a pass; otherwise, it is a fail.

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: Maintain records as per company policy.
  • 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 stable

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

⬆ Back to TOC

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-0153 Dry Heat Sterilizer Temp Sensor Dry Heat Sterilizer Microbiology Sterilization Depyrogenation Temperature °C 150 – 300 ±1°C 180 days External ISO17025
See also  Nutraceutical Sieve Shaker Speed (CAL-0292) - 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: 150°C
  • 25% of Range: 187.5°C
  • 50% of Range: 225°C
  • 75% of Range: 262.5°C
  • Maximum: 300°C

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
150°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
187.5°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
225°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
262.5°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
300°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure that the Dry Heat Sterilizer is clean and operational. Verify that the temperature sensor is calibrated and functioning.
  2. Stabilization: Allow the equipment to stabilize at the operating temperature for at least 30 minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value by subtracting the reference value from the observed value.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±1°C.
  6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

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

Approvals

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

⬆ Back to TOC

Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0153 Dry Heat Sterilizer Temp Sensor Microbiology Sterilization Temperature 150 – 300 °C ±1°C 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has been warmed up as per SOP
  • [ ] Clean the equipment as per cleaning procedures
  • [ ] Level the equipment if applicable
  • [ ] Confirm reference standards are valid and calibrated
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Record initial setpoints of the temperature sensor
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for analysis
See also  Burette 50 mL (CAL-0030) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the relevant personnel of the OOT condition
  • [ ] Document the deviation in the logbook
  • [ ] Trigger an impact review as per SOP

As Left Verification

  • [ ] Perform post-adjustment checks to confirm accuracy
  • [ ] Ensure all measurements are within specified limits

Documentation & Closure

  • [ ] Update equipment label with new calibration date
  • [ ] Attach calibration certificate to the logbook
  • [ ] Obtain reviewer sign-off on calibration records
  • [ ] Update next due date in the logbook

⬆ Back to TOC

Deviation Impact Assessment

Event Summary
Asset: Dry Heat Sterilizer Temp Sensor
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 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

Summary of investigation findings: [TBD]

Root Cause: [TBD]

CAPA Plan

Action Owner Due Date Effectiveness Check
[TBD] [TBD] [TBD] [TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

⬆ Back to TOC

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-0153 Dry Heat Sterilizer Temp Sensor Dry Heat Sterilizer Microbiology Sterilization [TBD] [TBD] [TBD] Temperature: 150 – 300 °C ±1°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: __________

⬆ Back to TOC