Micropipette Set (Micro Lab) (CAL-0242) – Calibration Documents

Calibration Documents: Micropipette Set (Micro Lab) (CAL-0242)

Asset ID CAL-0242
Equipment Micropipette Set (Micro Lab)
Equipment Type Micropipette
Department Microbiology
Area/Location Lab
Process Use Media prep
Parameter Volume
Units µL
Range Min 10
Range Max 1000
Acceptance Criteria ±1%
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 Micropipette Set (Micro Lab) is performed to ensure accurate volume measurements during media preparation in the Microbiology department. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0242
  • Equipment Name/Type: Micropipette Set (Micro Lab) / Micropipette
  • Department/Area: Microbiology / Lab
  • Process Use: Media prep
  • Parameter: Volume
  • Range: 10 µL to 1000 µL
  • Units: µL
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of measurement equipment.
  • Verification: The process of confirming that the equipment meets specified requirements.
  • Adjustment: The act of correcting the measurement output of the equipment.
  • 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 output over time.
  • Traceability: The ability to trace the measurement results back to national or international standards.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A periodic check performed to ensure the equipment remains within specified limits 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 and results.
  • Owner Department: Ensure equipment is available and accessible 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/stabilize as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and work area.
  • Check that the equipment is level before use.
  • Verify power supply is stable and within specifications.
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7. Standards & Tools

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

8. Calibration Strategy

The calibration will follow an As Found then As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the specified range of 10 µL to 1000 µL. It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the micropipette to stabilize in the environment for a minimum of 30 minutes.
  3. As Found checks and data capture: Measure the volume at each test point and record the results contemporaneously.
  4. Adjustment rules: If any measurement is OOT, follow the adjustment protocol; if adjustment is not possible, escalate to QA.
  5. As Left verification: Re-measure to confirm that the adjustments bring the equipment within tolerance.
  6. Labeling + documentation completion: Label the equipment with calibration date, due date, and technician’s name. Complete all documentation in accordance with ALCOA+ principles.

10. Acceptance Criteria & Calculations

The acceptance criteria for calibration is ±1%. The error calculation formula is:

Error (%) = (Observed Value – True Value) / True Value × 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 the equipment and stop its use.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain a file of calibration reports and certificates.
  • e-Records: [TBD]
  • Label content requirements: Include calibrated date, due date, technician’s 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 warmed up
  • Cleanliness checked
  • Leveling confirmed
  • 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-0242 Micropipette Set (Micro Lab) Micropipette Microbiology Lab Media prep Volume µL 10 – 1000 ±1% 180 days External ISO17025
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Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 10 µL
  • 25%: 252.5 µL
  • 50%: 505 µL
  • 75%: 757.5 µL
  • Maximum: 1000 µL

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
10 µL [TBD] [TBD] [TBD] ±0.1 µL [TBD] [TBD] [TBD] [TBD]
252.5 µL [TBD] [TBD] [TBD] ±2.525 µL [TBD] [TBD] [TBD] [TBD]
505 µL [TBD] [TBD] [TBD] ±5.05 µL [TBD] [TBD] [TBD] [TBD]
757.5 µL [TBD] [TBD] [TBD] ±7.575 µL [TBD] [TBD] [TBD] [TBD]
1000 µL [TBD] [TBD] [TBD] ±10 µL [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the micropipette is clean and calibrated. Gather all necessary materials.
  2. Stabilization: Allow the micropipette to stabilize at room temperature for at least 30 minutes.
  3. Performing Readings:
    • For each test point, perform three replicates.
    • Record the observed values for each replicate.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria.
  6. Documentation: Complete the results table with As Found and As Left values.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the micropipette.
  • Notify the supervisor immediately.
  • 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]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0242 Micropipette Set (Micro Lab) Microbiology Lab Volume 10 – 1000 µL ±1% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean equipment as per cleaning procedure
  • [ ] Level equipment if applicable
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set micropipette to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP
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As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label with calibration details
  • [ ] Attach calibration certificate to documentation
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date in logbook

Data Integrity (ALCOA+): Ensure all data is attributable, legible, contemporaneous, original, and accurate. Maintain records in compliance with GMP standards.

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Deviation Impact Assessment

Event Summary
Asset: Micropipette Set (Micro Lab)
Date: [TBD]
Discovered By: [TBD]
Document References: [TBD]
As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the affected equipment
  • Label/tag the equipment as out of tolerance
  • 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

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-0242 Micropipette Set (Micro Lab) Micropipette Microbiology Lab [TBD] [TBD] [TBD] Volume: 10 – 1000 µL ±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 (µL) Acceptance Criteria Pass/Fail
10 µL [TBD] ±1% [TBD]
100 µL [TBD] ±1% [TBD]
250 µL [TBD] ±1% [TBD]
500 µL [TBD] ±1% [TBD]
1000 µL [TBD] ±1% [TBD]

As Left Results

Test Point Measured Value (µL) Acceptance Criteria Pass/Fail
10 µL [TBD] ±1% [TBD]
100 µL [TBD] ±1% [TBD]
250 µL [TBD] ±1% [TBD]
500 µL [TBD] ±1% [TBD]
1000 µL [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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