Repeater Pipette/Dispenser (CAL-0025) – Calibration Documents

Calibration Documents: Repeater Pipette/Dispenser (CAL-0025)

Asset ID CAL-0025
Equipment Repeater Pipette/Dispenser
Equipment Type Repeater Pipette
Department QC
Area/Location Chemistry Lab
Process Use Dispensing
Parameter Volume
Units mL
Range Min 0.1
Range Max 10
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 Repeater Pipette/Dispenser is performed to ensure accurate dispensing of volumes within the specified range. This calibration controls risks associated with accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0025
  • Equipment Name/Type: Repeater Pipette/Dispenser
  • Department/Area: QC, Chemistry Lab
  • Process Use: Dispensing
  • Parameter: Volume
  • Range: 0.1 mL to 10 mL
  • Units: mL
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of comparing a measurement device to a known standard to ensure accuracy.
  • Verification: The process of confirming that a device meets specified requirements.
  • Adjustment: The act of modifying a device to bring it into compliance with specifications.
  • 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 a measurement device’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 step performed between calibrations to ensure ongoing 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 maintained.
  • External Service Provider: Conduct external calibrations as required.

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 work area and equipment.
  • Check leveling of the pipette/dispenser.
  • Verify power supply is stable and within specifications.
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7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: Calibration shall be traceable to ISO17025.
  • Certificate Validity Check: Ensure all calibration certificates are current.
  • Standard ID Placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0.1 mL and 10 mL) and midpoints.
  • Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the pipette/dispenser to stabilize as per manufacturer guidelines.
  3. As Found checks and data capture: Measure and record the volume dispensed at each calibration point.
  4. Adjustment rules: If OOT is detected, adjust the pipette/dispenser if allowed; otherwise, escalate to QA.
  5. As Left verification: Measure and record the volume dispensed again to confirm adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

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 – Target Value) / Target Value × 100

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration passes; otherwise, it fails.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Define 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 in accordance with 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 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-0025 Repeater Pipette/Dispenser Repeater Pipette QC Chemistry Lab Dispensing Volume mL 0.1 – 10 ±1% 180 days External ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0.1 mL
  • 25%: 2.6 mL
  • 50%: 5.05 mL
  • 75%: 7.6 mL
  • Maximum: 10 mL

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0.1 mL [TBD] [TBD] [TBD] ±0.001 mL [TBD] [TBD] [TBD] [TBD]
2.6 mL [TBD] [TBD] [TBD] ±0.026 mL [TBD] [TBD] [TBD] [TBD]
5.05 mL [TBD] [TBD] [TBD] ±0.0505 mL [TBD] [TBD] [TBD] [TBD]
7.6 mL [TBD] [TBD] [TBD] ±0.076 mL [TBD] [TBD] [TBD] [TBD]
10 mL [TBD] [TBD] [TBD] ±0.1 mL [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the pipette is clean and free from any contaminants.
  2. Stabilization: Allow the pipette to stabilize at room temperature for at least 30 minutes.
  3. Performing Readings: Dispense the specified volumes at each test point in replicates of three.
  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 and results in the results table.

Deviation Instruction for OOT

If any results fall outside of the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance.
  • 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-0025 Repeater Pipette/Dispenser QC Chemistry Lab Volume 0.1 – 10 mL ±1% 180 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set the pipette to specified setpoints
  • [ ] Perform multiple repeats for accuracy
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
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OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the supervisor/QA
  • [ ] Document the deviation
  • [ ] Trigger impact review process

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm results 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 Details
Asset Repeater Pipette/Dispenser
Date [TBD]
Discovered By [TBD]
Document References [TBD]
As Found Results Summary [TBD]

Immediate Containment Checklist

  • Stop use of the asset
  • Label/Tag the asset 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-0025 Repeater Pipette/Dispenser Repeater Pipette QC Chemistry Lab [TBD] [TBD] [TBD] Volume: 0.1 – 10 mL ±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 (mL) 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 (mL) 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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