Volumetric Flask 50 mL (CAL-0034) – Calibration Documents

Calibration Documents: Volumetric Flask 50 mL (CAL-0034)

Asset ID CAL-0034
Equipment Volumetric Flask 50 mL
Equipment Type Volumetric Flask
Department QC
Area/Location Glassware Room
Process Use Solution prep
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 Volumetric Flask 50 mL is performed to ensure accurate volume measurements during solution preparation in the QC department. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with GMP standards.

2. Scope

  • Asset ID: CAL-0034
  • Equipment Name/Type: Volumetric Flask 50 mL / Volumetric Flask
  • Department/Area: QC / Glassware Room
  • Process Use: Solution prep
  • Parameter: Volume
  • Range: 0 – 50 mL
  • Units: mL
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying the accuracy of a measurement instrument against a known standard.
  • 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 measurement falls outside specified limits.
  • Drift: The gradual change in an instrument’s output over time.
  • Traceability: The ability to trace the measurement results back to national or international standards.
  • Measurement Uncertainty: A parameter that defines the doubt about the result of a measurement.
  • Intermediate Check: A verification process conducted 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 document results.
  • QC/QA Reviewer: Review calibration documentation and results.
  • 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 equipment to warm up and stabilize as per manufacturer recommendations.
  • Maintain cleanliness of the workspace and equipment.
  • Check leveling of the equipment.
  • Verify power supply stability.

7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within their validity period.
See also  GC System (CAL-0122) - Calibration Documents

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints within the range of 0 – 50 mL. 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 volumetric flask to acclimate to the environment.
  3. As Found checks and data capture: Measure the volume at specified points and record results.
  4. Adjustment rules: If any measurement is OOT, escalate for adjustment as per SOP.
  5. As Left verification: Confirm that the adjustments bring the instrument within tolerance.
  6. Labeling + documentation completion: Ensure all records are complete and accurate.

Record raw observations contemporaneously to maintain ALCOA+ compliance.

10. Acceptance Criteria & Calculations

The acceptance criteria for the Volumetric Flask 50 mL is Class A. The error calculation formula is: Error (%) = (Observed Value – True Value) / True Value × 100. Pass/Fail logic will be based on whether the error falls within acceptable limits. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Review affected results/batches within the defined impact window.
  • Recalibration after repair/adjustment: Schedule recalibration as necessary.
  • 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 clean and leveled
  • Power supply stable
  • All tools and standards ready

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-0034 Volumetric Flask 50 mL Volumetric Flask QC Glassware Room Solution prep Volume mL 0 – 50 Class A 365 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

  • 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 volumetric flask is clean and free from contaminants.
  2. Stabilization: Allow the flask to acclimate to the environmental conditions for at least 30 minutes.
  3. Performing Readings: Measure each test point in replicates (minimum of 3 readings per point).
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors to the acceptance criteria.
  6. Documentation: Record all observations, calculations, and evaluations in the results table.

Deviation Instruction for 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-0034 Volumetric Flask 50 mL QC Glassware Room 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 volumetric flask according to cleaning SOP
  • [ ] Ensure the flask is leveled properly
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

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

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify the appropriate personnel
  • [ ] Document the deviation
  • [ ] Trigger impact review process
See also  Photo-stability Chamber UV (CAL-0185) - Calibration Documents

As Left Verification

  • [ ] Conduct post-adjustment checks to confirm accuracy
  • [ ] Ensure all measurements are within acceptance limits

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary Details
Asset Volumetric Flask 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 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-0034 Volumetric Flask 50 mL Volumetric Flask QC Glassware Room [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] ISO17025

Results

As Found Results

Test Point Measured Value (mL) Pass/Fail
0 mL [TBD] [TBD]
10 mL [TBD] [TBD]
20 mL [TBD] [TBD]
30 mL [TBD] [TBD]
40 mL [TBD] [TBD]
50 mL [TBD] [TBD]

As Left Results

Test Point Measured Value (mL) Pass/Fail
0 mL [TBD] [TBD]
10 mL [TBD] [TBD]
20 mL [TBD] [TBD]
30 mL [TBD] [TBD]
40 mL [TBD] [TBD]
50 mL [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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