Autoclave Chart Recorder Pressure (CAL-0221) – Calibration Documents

Calibration Documents: Autoclave Chart Recorder Pressure (CAL-0221)

Asset ID CAL-0221
Equipment Autoclave Chart Recorder Pressure
Equipment Type Chart Recorder
Department Microbiology/Sterile
Area/Location Sterilization
Process Use Recording
Parameter Pressure
Units bar
Range Min 0
Range Max 5
Acceptance Criteria ±1%
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 Chart Recorder Pressure is performed to ensure accurate recording of pressure within the sterilization process. This is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Inaccurate pressure readings can lead to ineffective sterilization, posing risks to product safety and compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0221
  • Equipment Name/Type: Autoclave Chart Recorder Pressure / Chart Recorder
  • Department/Area: Microbiology/Sterile / Sterilization
  • Process Use: Recording
  • Parameter: Pressure
  • Range: 0 to 5 bar
  • Units: bar
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a standard to ensure accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The process of correcting a measurement instrument to ensure it meets specified standards.
  • As Found: The condition of the instrument prior to any adjustments being made.
  • 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 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 expected 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 maintain records.
  • QC/QA Reviewer: Review calibration results and documentation.
  • 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 before calibration.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is level and stable.
  • Verify power supply is stable and within specifications.
See also  Fluorescence Spectrophotometer (CAL-0114) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of points for calibration 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 equipment to reach operating conditions.
  3. As Found checks and data capture: Record initial readings at specified points.
  4. Adjustment rules: If OOT is detected, adjust the instrument as permitted; otherwise, escalate the issue.
  5. As Left verification: Record final readings after adjustments.
  6. Labeling + documentation completion: Ensure all records are filled out contemporaneously (ALCOA+).

10. Acceptance Criteria & Calculations

Acceptance criteria for the calibration of the Autoclave Chart Recorder Pressure is ±1%. The error calculation formula is:

Error (%) = [(Observed Value – True Value) / True Value] x 100

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

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel.
  • 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: Maintain detailed records of calibration activities.
  • Calibration report/certificate filing: Store all calibration certificates securely.
  • 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
  • Cleanliness confirmed
  • Leveling checked
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

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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-0221 Autoclave Chart Recorder Pressure Chart Recorder Microbiology/Sterile Sterilization Recording 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%: 1.25 bar
  • 50%: 2.5 bar
  • 75%: 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] [TBD] [TBD] [TBD] [TBD] [TBD]
1.25 bar [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
2.5 bar [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
3.75 bar [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
5 bar [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the autoclave chart recorder is clean and free from any obstructions.
  2. Stabilization: Allow the equipment to stabilize for [TBD] 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 against the reference value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±1%.
  6. Documentation: Record all findings in the results table and ensure all data is compliant with ALCOA+ principles.

Deviation Instruction for OOT

  • Stop use of the equipment immediately.
  • Notify the Quality Assurance department.
  • 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-0221 Autoclave Chart Recorder Pressure Microbiology/Sterile Sterilization Pressure 0 to 5 bar ±1% 365 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set the pressure to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for analysis
See also  Graduated Cylinder 10 mL (CAL-0040) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review process

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 in logbook

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Deviation Impact Assessment

Event Summary Details
Asset Autoclave Chart Recorder Pressure
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use
  • Label/Tag
  • 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
  • Legible
  • Contemporaneous
  • Original
  • Accurate
  • Complete
  • Consistent
  • Enduring
  • Available

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/Re-Test/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-0221 Autoclave Chart Recorder Pressure Chart Recorder Microbiology/Sterile 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] 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: [TBD]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

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