Micropipette 20-200 µL (CAL-0022) – Calibration Documents

Calibration Documents: Micropipette 20-200 µL (CAL-0022)

Asset ID CAL-0022
Equipment Micropipette 20-200 µL
Equipment Type Micropipette
Department QC
Area/Location Chemistry Lab
Process Use Sample prep
Parameter Volume
Units µL
Range Min 20
Range Max 200
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 20-200 µL is performed to ensure accurate volume measurements during sample preparation in the QC department. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with regulatory standards.

2. Scope

  • Asset ID: CAL-0022
  • Equipment Name/Type: Micropipette 20-200 µL / Micropipette
  • Department/Area: QC / Chemistry Lab
  • Process Use: Sample prep
  • Parameter: Volume
  • Range: 20 – 200 µL
  • Units: µL
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of an instrument against a standard.
  • Verification: The confirmation that an instrument meets specified requirements.
  • Adjustment: The act of altering an instrument to bring it into compliance with standards.
  • 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 defined acceptance criteria.
  • Drift: The gradual change in an instrument’s performance over time.
  • Traceability: The ability to trace the history, application, or location of an item through documented records.
  • Measurement Uncertainty: A parameter that characterizes the range of values within which the true value is expected 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • 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 warm-up/stabilization time for the micropipette.
  • Maintain cleanliness of the equipment and workspace.
  • Check leveling of the micropipette.
  • Verify power supply checks are completed.

7. Standards & Tools

  • Reference Standards Required: Calibration weights or standards compliant with ISO17025.
  • Traceability Statement: Calibration is traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID Placeholders: [TBD]
See also  ICP-OES (CAL-0116) - Calibration Documents

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (20 µL and 200 µL) and midpoints (100 µL).
  • Replicate readings at each point: 3 repeats are recommended for accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the micropipette to stabilize as per manufacturer’s guidelines.
  3. As Found checks and data capture: Measure and record the volume at each test point.
  4. Adjustment rules: If OOT is found, escalate for adjustment as per SOP.
  5. As Left verification: Re-measure to confirm adjustments are within tolerance.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment.

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

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% of the target volume.

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

Pass/Fail logic: If the error is within ±1%, the result is a pass; otherwise, it is a fail.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and initiate deviation process.
  • Impact assessment trigger: Define impact window and review of 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: Calibrated date, due date, by whom, 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
  • Workspace cleanliness checked
  • Leveling confirmed
  • Power supply verified

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-0022 Micropipette 20-200 µL Micropipette QC Chemistry Lab Sample prep Volume µL 20 – 200 ±1% 180 days External ISO17025
See also  Autoclave Pressure Gauge (CAL-0151) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points for calibration will be selected as follows:

  • Minimum (20 µL)
  • 25% of Range (65 µL)
  • 50% of Range (110 µL)
  • 75% of Range (155 µL)
  • Maximum (200 µL)

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
20 µL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
65 µL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
110 µL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
155 µL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
200 µL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the micropipette is clean and calibrated equipment is available.
  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 of ±1%.
  6. Documentation: Complete the results table with As Found and As Left data.

Deviation Instruction for OOT

If any observed value is 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
[Signature/Date] [Signature/Date] [Signature/Date]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0022 Micropipette 20-200 µL QC Chemistry Lab Volume 20 – 200 µL ±1% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow micropipette to warm up as per manufacturer guidelines
  • [ ] Clean the micropipette as per SOP
  • [ ] Ensure the micropipette is leveled
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for recording

As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results
See also  Inline pH Sensor (Bioreactor) (CAL-0092) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the micropipette
  • [ ] Stop use immediately
  • [ ] Notify QA and relevant 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 is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary
Asset: Micropipette 20-200 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 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

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-0022 Micropipette 20-200 µL Micropipette QC Chemistry Lab [TBD] [TBD] [TBD] Volume (20-200) 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
20 µL [TBD] ±1% [TBD]
50 µL [TBD] ±1% [TBD]
100 µL [TBD] ±1% [TBD]
150 µL [TBD] ±1% [TBD]
200 µL [TBD] ±1% [TBD]

As Left Results

Test Point Measured Value (µL) Acceptance Criteria Pass/Fail
20 µL [TBD] ±1% [TBD]
50 µL [TBD] ±1% [TBD]
100 µL [TBD] ±1% [TBD]
150 µL [TBD] ±1% [TBD]
200 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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