GC Headspace Sampler (CAL-0123) – Calibration Documents

Calibration Documents: GC Headspace Sampler (CAL-0123)

Asset ID CAL-0123
Equipment GC Headspace Sampler
Equipment Type Headspace Sampler
Department QC
Area/Location Instrument Room
Process Use Residual solvents
Parameter Temperature
Units °C
Range Min 40
Range Max 200
Acceptance Criteria ±1°C
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 GC Headspace Sampler is performed to ensure accurate measurement of temperature during the analysis of residual solvents. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with regulatory requirements.

2. Scope

  • Asset ID: CAL-0123
  • Equipment Name/Type: GC Headspace Sampler / Headspace Sampler
  • Department/Area: QC / Instrument Room
  • Process Use: Residual solvents
  • Parameter: Temperature
  • Range: 40°C to 200°C
  • Units: °C
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of an instrument.
  • Verification: Confirmation that an instrument meets specified requirements.
  • Adjustment: The act of altering an 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 an instrument’s measurement 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 document results.
  • QC/QA Reviewer: Review calibration documentation for compliance.
  • 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 for warm-up/stabilization of the equipment as per manufacturer guidelines.
  • Maintain cleanliness of the instrument and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply stability and functionality.
See also  Water Bath Temp Sensor (CAL-0158) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure certificates are current and valid.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints of the specified range (40°C to 200°C). 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 GC Headspace Sampler to stabilize at the operating temperature.
  3. As Found checks and data capture: Record temperature readings at the defined points.
  4. Adjustment rules: If any readings are OOT, follow escalation procedures for adjustment.
  5. As Left verification: Confirm that all adjustments have brought the instrument within specifications.
  6. Labeling + documentation completion: Complete all required documentation and label the instrument accordingly.

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

10. Acceptance Criteria & Calculations

Acceptance criteria for the GC Headspace Sampler is ±1°C. The error calculation formula is:

Error = Observed Value – Reference 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 the equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • 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 as per company policy.
  • 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 checked
  • Leveling confirmed
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

See also  Incubator Temp Sensor (20-25°C) (CAL-0156) - Calibration Documents

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-0123 GC Headspace Sampler Headspace Sampler QC Instrument Room Residual solvents Temperature °C 40 – 200 ±1°C 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Min: 40°C
  • 25%: 85°C
  • 50%: 120°C
  • 75%: 155°C
  • Max: 200°C

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
40°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
85°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
120°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
155°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]
200°C [TBD] [TBD] [TBD] ±1°C [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the GC Headspace Sampler is clean and free from any contaminants.
  2. Stabilization: Allow the equipment to stabilize at room temperature for at least 30 minutes before calibration.
  3. Performing Readings:
    • Set the sampler to the first test point.
    • Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading 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 findings in the results table and ensure all data is ALCOA+ compliant.

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and QA.
  • 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-0123 GC Headspace Sampler QC Instrument Room Temperature 40 – 200 °C ±1°C 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions
  • [ ] Ensure equipment has warmed up
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment
  • [ ] Check reference standards validity
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set the temperature to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  Top Loading Balance 0.1 g (CAL-0004) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all parameters are within 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 Details
Asset GC Headspace Sampler
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use of the equipment
  • Label/Tag the equipment 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]

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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-0123 GC Headspace Sampler Headspace Sampler QC Instrument Room [TBD] [TBD] [TBD] Temperature: 40 – 200 °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: ___________

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