Burette 50 mL (CAL-0030) – Calibration Documents

Calibration Documents: Burette 50 mL (CAL-0030)

Asset ID CAL-0030
Equipment Burette 50 mL
Equipment Type Burette
Department QC
Area/Location Chemistry Lab
Process Use Titration
Parameter Volume
Units mL
Range Min 0
Range Max 50
Acceptance Criteria Class A
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 Burette 50 mL is performed to ensure accurate volume measurements during titration processes 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-0030
Equipment Name/Type: Burette 50 mL / Burette
Department/Area: QC / Chemistry Lab
Process Use: Titration
Parameter: Volume
Range: 0 – 50 mL
Units: mL
Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: The process of confirming that an instrument meets specified requirements.
  • Adjustment: The act of modifying an instrument to bring it into compliance with specified 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 instrument’s measurements fall outside specified limits.
  • Drift: The gradual change in an instrument’s measurement accuracy 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 periodic check of an instrument’s performance between full calibrations.

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 results and documentation.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • 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 equipment and surrounding area.
  • Check that the burette is leveled properly before use.
  • Verify power supply is stable and within required specifications.
See also  AAS (CAL-0115) - Calibration Documents

7. Standards & Tools

Reference Standards Required: [TBD]
Traceability Statement: Calibration traceable to ISO17025.
Certificate Validity Check: Ensure all calibration certificates are current and valid.

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. A minimum of 5 measurement points will be taken, including endpoints (0 mL and 50 mL) and midpoints. Each point will have 3 replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the burette to stabilize in the environment.
  3. As Found checks and data capture: Measure and record the volume at each point.
  4. Adjustment rules: If OOT is found, escalate for adjustment as per SOP.
  5. As Left verification: Confirm that the instrument is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment.

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

10. Acceptance Criteria & Calculations

Acceptance Criteria: Class A
Error Calculation Formula: Error (%) = (Observed Value – True Value) / True Value * 100
Pass/Fail Logic: If error is within acceptance criteria, pass; otherwise, fail.
Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed.
  • 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: Calibrated date, due date, by whom, status.

13. Annexures

Annexure A: Calibration Data Sheet (test points, ref, observed, error, acceptance, pass/fail; include As Found + As Left columns)
Annexure B: Quick checklist
Annexure C: Example label text (with [TBD] placeholders)

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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-0030 Burette 50 mL Burette QC Chemistry Lab Titration Volume mL 0 – 50 Class A 365 days External ISO17025
See also  Disintegration Tester (CAL-0131) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following values:

  • Min: 0 mL
  • 25%: 12.5 mL
  • 50%: 25 mL
  • 75%: 37.5 mL
  • Max: 50 mL

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
12.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
25 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
37.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the burette is clean and free from any contaminants.
  2. Stabilization: Allow the burette to stabilize at room temperature for at least 30 minutes.
  3. Performing Readings:
    • Fill the burette with the calibration standard.
    • Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the errors against the acceptance criteria.
  6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

If any observed value is out of tolerance (OOT):

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • 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-0030 Burette 50 mL QC Chemistry Lab Volume 0 – 50 mL Class A 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the burette thoroughly
  • [ ] Ensure the burette is level
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set initial measurement setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document deviation
  • [ ] Trigger impact review process

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all measurements are within specified limits
See also  Stability Chamber Temp Probe (CAL-0180) - Calibration Documents

Documentation & Closure

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

Acceptance Criteria: All measurements must meet Class A standards.
Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.
Traceability: Calibration must be traceable to ISO17025 standards.

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Deviation Impact Assessment

Event Summary
Asset: Burette 50 mL
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: [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-0030 Burette 50 mL Burette QC Chemistry Lab [TBD] [TBD] [TBD] Volume: 0 – 50 mL Class A

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] Traceability: ISO17025

Results

As Found Results

Test Point Measured Value (mL) Acceptance Criteria Pass/Fail
0 mL [TBD] Class A [TBD]
10 mL [TBD] Class A [TBD]
20 mL [TBD] Class A [TBD]
30 mL [TBD] Class A [TBD]
40 mL [TBD] Class A [TBD]

As Left Results

Test Point Measured Value (mL) Acceptance Criteria Pass/Fail
0 mL [TBD] Class A [TBD]
10 mL [TBD] Class A [TBD]
20 mL [TBD] Class A [TBD]
30 mL [TBD] Class A [TBD]
40 mL [TBD] Class A [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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