Volumetric Flask 25 mL (CAL-0033) – Calibration Documents

Calibration Documents: Volumetric Flask 25 mL (CAL-0033)

Asset ID CAL-0033
Equipment Volumetric Flask 25 mL
Equipment Type Volumetric Flask
Department QC
Area/Location Glassware Room
Process Use Solution prep
Parameter Volume
Units mL
Range Min 0
Range Max 25
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 25 mL is performed to ensure accurate volume measurements during solution preparation in the QC department. This calibration controls risks associated with accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with GMP standards.

2. Scope

  • Asset ID: CAL-0033
  • Equipment Name/Type: Volumetric Flask 25 mL / Volumetric Flask
  • Department/Area: QC / Glassware Room
  • Process Use: Solution prep
  • Parameter: Volume
  • Range: 0 – 25 mL
  • Units: mL
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: The confirmation that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement 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 measurement falls outside the specified acceptance criteria.
  • Drift: The gradual change in the measurement accuracy 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 that characterizes the range of values within which the true value is expected to lie.
  • Intermediate Check: A periodic verification of an instrument’s performance between 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 records and ensure compliance.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as per schedule.

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 workspace and equipment.
  • Check leveling of the equipment before use.
  • Verify power supply is stable and within specifications.
See also  RTD Sensor Pt100 (CAL-0052) - Calibration Documents

7. Standards & Tools

  • Reference Standards: Class A volumetric standards.
  • Traceability Statement: Calibration traceable to ISO17025.
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID: [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 mL, 25 mL) and midpoints (12.5 mL).
  • Replicate readings at each point: 3 repeats for accuracy verification.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the volumetric flask to acclimate to the laboratory environment.
  3. As Found checks and data capture: Measure the volume at specified points and record observations contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is detected, escalate to QA for further action; adjustments are only permitted if within guidelines.
  5. As Left verification: Confirm that the instrument meets acceptance criteria after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

10. Acceptance Criteria & Calculations

Acceptance criteria: Class A

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

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

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Review affected results/batches within the impact window.
  • Recalibration after repair/adjustment: Schedule recalibration post any adjustments.
  • QA disposition: [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: 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

  • Check environmental conditions.
  • Verify equipment cleanliness.
  • Ensure proper leveling.
  • Confirm power supply stability.

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

Status: [TBD]

⬆ Back to TOC

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-0033 Volumetric Flask 25 mL Volumetric Flask QC Glassware Room Solution prep Volume mL 0 – 25 Class A 365 days External ISO17025
See also  Liquid Filler Volume Calibration (CAL-0213) - 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 (0 mL)
  • 25% of Range (6.25 mL)
  • 50% of Range (12.5 mL)
  • 75% of Range (18.75 mL)
  • Maximum (25 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]
6.25 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
12.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
18.75 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
25 mL [TBD] [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 [TBD] minutes.
  3. Performing Readings: Fill the flask to each test point level, ensuring to take three replicate measurements for accuracy.
  4. Calculating Error: For each test point, calculate the error as: Error = Observed Value – Reference Value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria.
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the volumetric flask.
  • 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]

⬆ Back to TOC

Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0033 Volumetric Flask 25 mL QC Glassware Room Volume 0 – 25 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 as per cleaning procedure
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set the volumetric flask to specified setpoints
  • [ ] Perform repeats as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations
See also  BOD Incubator Temp Sensor (CAL-0157) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the equipment
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review as per SOP

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

Acceptance Criteria: Class A

Data Integrity (ALCOA+): Ensure all data is attributable, legible, contemporaneous, original, and accurate.

Traceability: Calibration must be traceable to ISO17025 standards.

As Found/As Left: Document conditions before and after calibration.

⬆ Back to TOC

Deviation Impact Assessment

Event Summary Details
Asset Volumetric Flask 25 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/Re-Test/Recall Triggers: [TBD]

⬆ Back to TOC

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-0033 Volumetric Flask 25 mL Volumetric Flask QC Glassware Room [TBD] [TBD] [TBD] Volume (0 – 25 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
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (mL) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ___________

Checked by: ______________________ Date: ___________

Approved by: ______________________ Date: ___________

⬆ Back to TOC