Micropipette 2-20 µL (CAL-0021) – Calibration Documents

Calibration Documents: Micropipette 2-20 µL (CAL-0021)

Asset ID CAL-0021
Equipment Micropipette 2-20 µL
Equipment Type Micropipette
Department QC
Area/Location Chemistry Lab
Process Use Sample prep
Parameter Volume
Units µL
Range Min 2
Range Max 20
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 2-20 µL is performed to ensure accurate volume measurements during sample preparation in the Chemistry Lab. This calibration controls risks associated with accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0021
  • Equipment Name/Type: Micropipette 2-20 µL / Micropipette
  • Department/Area: QC / Chemistry Lab
  • Process Use: Sample prep
  • Parameter: Volume
  • Range: 2 µL to 20 µL
  • Units: µL
  • Calibration Frequency: Every 180 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: Confirming that an instrument meets specified requirements.
  • Adjustment: Modifying 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 instrument’s performance does not meet specified acceptance criteria.
  • Drift: The gradual change in an instrument’s performance 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 continued accuracy.

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 records and ensure compliance.
  • Owner Department: Ensure equipment is available and properly maintained.
  • External Service Provider: Conduct external calibrations 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 work area and equipment.
  • Check leveling of the equipment before use.
  • Verify power supply is stable and within specifications.
See also  Micropipette 100-1000 µL (CAL-0023) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within validity period.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: 5 points including endpoints (2 µL and 20 µL) and midpoints.
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the micropipette to stabilize in the calibration environment.
  3. As Found checks and data capture: Measure and record the volume at each calibration point.
  4. Adjustment rules: If OOT is found, follow adjustment procedures if allowed; otherwise, escalate to QA.
  5. As Left verification: Measure and record the volume again after any adjustments.
  6. Labeling + documentation completion: Ensure all records are completed and labeled appropriately.

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

10. Acceptance Criteria & Calculations

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

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

Pass/Fail Logic: If the error falls 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 QA and initiate deviation report.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed before returning to service.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records for audit purposes.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, by whom, 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 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-0021 Micropipette 2-20 µL Micropipette QC Chemistry Lab Sample prep Volume µL 2 – 20 ±1% 180 days External ISO17025
See also  Chromatography Skid Flow Meter (CAL-0311) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the specified range of 2 µL to 20 µL. The following points will be used:

  • 2 µL (Minimum)
  • 5 µL (25%)
  • 10 µL (50%)
  • 15 µL (75%)
  • 20 µL (Maximum)

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
2 µL [TBD] [TBD] [TBD] ±0.02 µL [TBD] [TBD] [TBD] [TBD]
5 µL [TBD] [TBD] [TBD] ±0.05 µL [TBD] [TBD] [TBD] [TBD]
10 µL [TBD] [TBD] [TBD] ±0.1 µL [TBD] [TBD] [TBD] [TBD]
15 µL [TBD] [TBD] [TBD] ±0.15 µL [TBD] [TBD] [TBD] [TBD]
20 µL [TBD] [TBD] [TBD] ±0.2 µL [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the micropipette is clean and free from any contaminants.
  2. Stabilization: Allow the micropipette to stabilize at room temperature for at least 30 minutes.
  3. Performing Readings:
    • Calibrate using the selected test points.
    • Take three replicates for each test point.
  4. Calculating Error: Calculate the error for each test point using the formula:
    Error = (Observed – Ref Value) / Ref Value * 100%.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±1%.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

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 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-0021 Micropipette 2-20 µL QC Chemistry Lab Volume 2 – 20 µL ±1% 180 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results
See also  Tablet Hardness Tester (CAL-0132) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the micropipette
  • [ ] Stop use of the micropipette immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review as per SOP

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 logbook
  • [ ] Obtain reviewer sign-off
  • [ ] Update next due date for calibration

Data Integrity (ALCOA+): Ensure all data recorded is Accurate, Legible, Contemporaneous, Original, and Attributable.

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Deviation Impact Assessment

Event Summary Details
Asset Micropipette 2-20 µL
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

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-0021 Micropipette 2-20 µL Micropipette QC Chemistry Lab [TBD] [TBD] [TBD] Volume (2-20 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) Pass/Fail
2 µL [TBD] [TBD]
5 µL [TBD] [TBD]
10 µL [TBD] [TBD]
15 µL [TBD] [TBD]
20 µL [TBD] [TBD]

As Left Results

Test Point Measured Value (µL) Pass/Fail
2 µL [TBD] [TBD]
5 µL [TBD] [TBD]
10 µL [TBD] [TBD]
15 µL [TBD] [TBD]
20 µL [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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