Volumetric Flask 100 mL (CAL-0035) – Calibration Documents

Calibration Documents: Volumetric Flask 100 mL (CAL-0035)

Asset ID CAL-0035
Equipment Volumetric Flask 100 mL
Equipment Type Volumetric Flask
Department QC
Area/Location Glassware Room
Process Use Solution prep
Parameter Volume
Units mL
Range Min 0
Range Max 100
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 100 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-0035
  • Equipment Name/Type: Volumetric Flask 100 mL / Volumetric Flask
  • Department/Area: QC / Glassware Room
  • Process Use: Solution prep
  • Parameter: Volume
  • Range: 0 – 100 mL
  • Units: mL
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a known standard to determine its accuracy.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The act of altering a measurement instrument to bring it into compliance with specified standards.
  • As Found: The condition of the instrument before any adjustments are made.
  • 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 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 that characterizes the range of values within which the true value is asserted to lie.
  • Intermediate Check: A periodic verification of an instrument’s performance between scheduled calibrations.

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 in good condition for calibration.
  • External Service Provider: Conduct external calibration 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 and surrounding area.
  • Check that the flask is leveled before use.
  • Verify power supply checks are completed if applicable [TBD].
See also  Micropipette 2-20 µL (CAL-0021) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. A minimum of 5 measurement points will be taken, including endpoints (0 mL and 100 mL) and midpoints. Each point will have 3 replicate readings to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary equipment and reference standards.
  2. Stabilization: Allow the volumetric flask to acclimate to the working environment.
  3. As Found checks and data capture: Measure the volume at each defined point and record results contemporaneously (ALCOA+).
  4. Adjustment rules: If any measurement is OOT, escalate for further evaluation and adjustment if allowed.
  5. As Left verification: Re-measure to confirm adjustments are within acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the flask with calibration details.

10. Acceptance Criteria & Calculations

The acceptance criteria for the Volumetric Flask 100 mL is Class A. The error calculation formula is:

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

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

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop use until resolved.
  • Notification & deviation initiation: Notify QA and initiate a deviation report.
  • Impact assessment trigger: Review affected results/batches within the defined impact window.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain records of calibration certificates.
  • e-Records if applicable: [TBD]
  • Label Content Requirements: Calibrated date, due date, technician name, status.

13. Annexures

  • Annexure A: Calibration Data Sheet table (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).
See also  TOC Analyzer Offline (CAL-0096) - Calibration Documents

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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-0035 Volumetric Flask 100 mL Volumetric Flask QC Glassware Room Solution prep Volume mL 0 – 100 Class A 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 mL
  • 25%: 25 mL
  • 50%: 50 mL
  • 75%: 75 mL
  • Maximum: 100 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]
25 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
75 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
100 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the volumetric flask is clean and free of contaminants.
  2. Stabilization: Allow the flask to acclimate to the environmental conditions for at least 30 minutes.
  3. Performing Readings:
    • Fill the flask to each test point (0, 25, 50, 75, 100 mL).
    • Take three replicate readings for each test point.
  4. Calculating Error: Determine the error for each test point by comparing the observed values to the reference values.
  5. Evaluation: Assess whether each test point meets the acceptance criteria (Class A).
  6. Documentation: Record all observations, calculations, and results in the results table.

Deviation Instruction for OOT

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

  • Stop use of the equipment.
  • Notify the QA department 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]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0035 Volumetric Flask 100 mL QC Glassware Room Volume 0 – 100 mL Class A 365 days ISO17025

Pre-calibration

  • [ ] Check environmental conditions
  • [ ] Ensure equipment has warmed up
  • [ ] Clean the volumetric flask
  • [ ] Level the equipment if necessary
  • [ ] Verify reference standards validity
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set initial measurement setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  Autoclave Pressure Gauge (CAL-0151) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary Details
Asset Volumetric Flask 100 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

Investigation Summary Placeholders: [TBD]

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-0035 Volumetric Flask 100 mL Volumetric Flask QC Glassware Room [TBD] [TBD] [TBD] Volume (0 – 100 mL) Class A

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

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

As Left Results

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