Calibration Documents: Autoclave Pressure Gauge (CAL-0151)

Asset ID	CAL-0151
Equipment	Autoclave Pressure Gauge
Equipment Type	Pressure Gauge
Department	Microbiology
Area/Location	Sterilization
Process Use	Sterilization
Parameter	Pressure
Units	bar
Range Min	0
Range Max	5
Acceptance Criteria	±1%
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Autoclave Pressure Gauge is performed to ensure accurate pressure readings during the sterilization process. This is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Inaccurate pressure measurements can lead to ineffective sterilization, posing risks to product safety and compliance.

2. Scope

• Asset ID: CAL-0151
• Equipment Name/Type: Autoclave Pressure Gauge / Pressure Gauge
• Department/Area: Microbiology / Sterilization
• Process Use: Sterilization
• Parameter: Pressure
• Range: 0 – 5 bar
• Units: bar
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of comparing a measurement device against a known standard to ensure accuracy.
• Verification: The confirmation that a measurement device is functioning correctly.
• Adjustment: The process of correcting a measurement device to align with the standard.
• As Found: The condition of the equipment prior to any adjustments.
• As Left: The condition of the equipment after adjustments have been made.
• OOT (Out of Tolerance): A condition where the measurement falls outside the defined acceptance criteria.
• Drift: The gradual change in the measurement accuracy of a 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 is asserted to lie.
• Intermediate Check: A verification process conducted between calibrations to ensure ongoing 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 for compliance.
• Owner Department: Ensure equipment is available and properly 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 before calibration.
• 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.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: Ensure all standards used are within their calibration validity period.
• Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints (0 bar and 5 bar) and midpoints (2.5 bar). Each point will have three replicate readings taken as a best practice.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and standards.
2. Stabilization: Allow the gauge to stabilize at room temperature.
3. As Found checks and data capture: Record initial pressure readings at defined points.
4. Adjustment rules: If OOT is detected, adjust the gauge according to manufacturer specifications; if adjustment is not possible, escalate the issue.
5. As Left verification: Re-check the gauge after adjustments to confirm compliance.
6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

Record raw observations contemporaneously to ensure ALCOA+ compliance.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% of the reading. The error calculation formula is:

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

Pass/Fail logic: If the error is within ±1%, the gauge passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag the equipment and stop its use.
• Notification & deviation initiation: Notify QA and initiate a deviation report.
• Impact assessment trigger: Review the impact on affected results/batches within the defined impact window.
• Recalibration after repair/adjustment: Ensure recalibration is performed post-repair.
• QA disposition placeholders: [TBD]

12. Records & Retention

• Logbook entries: Document all calibration activities.
• Calibration report/certificate filing: Maintain records for audits.
• 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 Point	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 confirmed
• Leveling checked
• Power supply stable

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-0151	Autoclave Pressure Gauge	Pressure Gauge	Microbiology	Sterilization	Sterilization	Pressure	bar	0 – 5	±1%	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 0 bar
• 25% of Range: 1.25 bar
• 50% of Range: 2.5 bar
• 75% of Range: 3.75 bar
• Maximum: 5 bar

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
0 bar	[TBD]	[TBD]	[TBD]	±0.01 bar	[TBD]	[TBD]	[TBD]	[TBD]
1.25 bar	[TBD]	[TBD]	[TBD]	±0.01 bar	[TBD]	[TBD]	[TBD]	[TBD]
2.5 bar	[TBD]	[TBD]	[TBD]	±0.01 bar	[TBD]	[TBD]	[TBD]	[TBD]
3.75 bar	[TBD]	[TBD]	[TBD]	±0.01 bar	[TBD]	[TBD]	[TBD]	[TBD]
5 bar	[TBD]	[TBD]	[TBD]	±0.01 bar	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the autoclave pressure gauge is clean and free from any obstructions.
2. Stabilization: Allow the gauge to stabilize at room temperature for at least 30 minutes before calibration.
3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
4. Calculating Error: Calculate the error for each observed value against the reference value.
5. Evaluation: Compare the calculated error against the acceptance criteria of ±1%.
6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

• 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
____________________ / Date: __________	____________________ / Date: __________	____________________ / Date: __________

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Calibration Checklist

Asset ID	Equipment	Dept	Area	Parameter	Range	Acceptance	Frequency	Traceability
CAL-0151	Autoclave Pressure Gauge	Microbiology	Sterilization	Pressure	0 – 5 bar	±1%	365 days	ISO17025

Pre-calibration

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

As Found Execution

• [ ] Set pressure gauge to specified setpoints
• [ ] Perform repeat measurements
• [ ] Record raw data accurately
• [ ] Perform necessary calculations

OOT Immediate Actions

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

As Left Verification

• [ ] Conduct post-adjustment checks
• [ ] Confirm all measurements are within acceptance 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, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: Autoclave Pressure Gauge 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: [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-0151	Autoclave Pressure Gauge	Pressure Gauge	Microbiology	Sterilization	[TBD]	[TBD]	[TBD]	Pressure: 0 – 5 bar	±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 (bar)	Acceptance Criteria	Pass/Fail
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 (bar)	Acceptance Criteria	Pass/Fail
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: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: _____________________ Date: ___________

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