Volumetric Flask 200 mL (CAL-0036) – Calibration Documents

Calibration Documents: Volumetric Flask 200 mL (CAL-0036)

Asset ID CAL-0036
Equipment Volumetric Flask 200 mL
Equipment Type Volumetric Flask
Department QC
Area/Location Glassware Room
Process Use Solution prep
Parameter Volume
Units mL
Range Min 0
Range Max 200
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 200 mL is performed to ensure the accuracy of volume measurements used in solution preparation. This calibration controls risks related to patient safety, batch quality, and data integrity by ensuring that the equipment meets specified performance criteria.

2. Scope

  • Asset ID: CAL-0036
  • Equipment Name/Type: Volumetric Flask 200 mL / Volumetric Flask
  • Department/Area: QC / Glassware Room
  • Process Use: Solution prep
  • Parameter: Volume
  • Range: 0 – 200 mL
  • Units: mL
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The process of modifying a measurement instrument to bring it into compliance with specified standards.
  • As Found: The condition of the equipment prior to any adjustments made during calibration.
  • As Left: The condition of the equipment after calibration adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement results fall outside the specified acceptance criteria.
  • Drift: The gradual change in the measurement output of an instrument 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 associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurement.
  • Intermediate Check: A verification process conducted between calibrations to ensure continued accuracy of the equipment.

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/stabilize as per manufacturer guidelines.
  • Ensure cleanliness of the volumetric flask prior to calibration.
  • Check leveling of the equipment.
  • Verify power supply is stable and within specifications.
See also  Inline Pressure Transmitter (Reactor) (CAL-0201) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: Calibration traceability 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. The minimum number of calibration points will be five, including endpoints (0 mL and 200 mL) and midpoints (100 mL). Each point will have three replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the volumetric flask to stabilize in the calibration environment.
  3. As Found Checks: Measure the volume at each calibration point and record data contemporaneously.
  4. Adjustment Rules: If OOT is detected, escalate for adjustment as per SOP.
  5. As Left Verification: Measure again after any adjustments to confirm compliance.
  6. Labeling + Documentation Completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Volumetric Flask 200 mL is Class A. The error calculation formula will be:

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

Pass/Fail logic will be based on whether the error falls within the acceptance criteria. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification: Notify relevant personnel and initiate deviation process.
  • Impact Assessment Trigger: Define impact window and review affected results/batches.
  • Recalibration: Conduct recalibration after any repair or adjustment.
  • QA Disposition: [TBD]

12. Records & Retention

  • Logbook entries must be made for each calibration.
  • Calibration report/certificate filing must be maintained.
  • 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

  • Check environmental conditions.
  • Verify equipment cleanliness.
  • Confirm calibration standards are available.
  • Ensure documentation is 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-0036 Volumetric Flask 200 mL Volumetric Flask QC Glassware Room Solution prep Volume mL 0 – 200 Class A 365 days External ISO17025
See also  Steam Pressure Gauge (CAL-0323) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 mL
  • 25%: 50 mL
  • 50%: 100 mL
  • 75%: 150 mL
  • Maximum: 200 mL

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mL 0 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50 mL 50 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
100 mL 100 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
150 mL 150 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
200 mL 200 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the volumetric flask is clean and free from any residues.
  2. Stabilization: Allow the flask to acclimate to the environmental conditions for at least 30 minutes.
  3. Performing Readings: Measure the volume at each test point in replicates (minimum of 3 readings per point).
  4. Calculating Error: Calculate the error for each test point using the formula: Error = Observed – Ref Value.
  5. Evaluation: Compare the calculated error against the acceptance criteria (Class A).
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

If any results fall outside the acceptance criteria:

  • 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-0036 Volumetric Flask 200 mL QC Glassware Room Volume 0 – 200 mL Class A 365 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set initial measurement setpoints
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Depyrogenation Tunnel Temp Sensor (CAL-0222) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the volumetric flask
  • [ ] Notify the supervisor or QA
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review process

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all measurements are within acceptance limits

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Volumetric Flask 200 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-0036 Volumetric Flask 200 mL Volumetric Flask QC Glassware Room [TBD] [TBD] [TBD] Volume: 0 – 200 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) Pass/Fail
0 mL [TBD] [TBD]
50 mL [TBD] [TBD]
100 mL [TBD] [TBD]
150 mL [TBD] [TBD]
200 mL [TBD] [TBD]

As Left Results

Test Point Measured Value (mL) Pass/Fail
0 mL [TBD] [TBD]
50 mL [TBD] [TBD]
100 mL [TBD] [TBD]
150 mL [TBD] [TBD]
200 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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