Volumetric Flask 10 mL (CAL-0032) – Calibration Documents

Calibration Documents: Volumetric Flask 10 mL (CAL-0032)

Asset ID CAL-0032
Equipment Volumetric Flask 10 mL
Equipment Type Volumetric Flask
Department QC
Area/Location Glassware Room
Process Use Solution prep
Parameter Volume
Units mL
Range Min 0
Range Max 10
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 10 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-0032
  • Equipment Name/Type: Volumetric Flask 10 mL / Volumetric Flask
  • Department/Area: QC / Glassware Room
  • Process Use: Solution prep
  • Parameter: Volume
  • Range: 0 – 10 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 a measurement instrument meets specified requirements.
  • Adjustment: The act of modifying a measurement instrument to bring it into compliance with specified standards.
  • As Found: The condition of the instrument prior to any adjustments being made.
  • As Left: The condition of the instrument after 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 a measurement instrument’s performance 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 of a measurement lies.
  • Intermediate Check: A periodic check performed to ensure the ongoing accuracy of a measurement instrument.

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 accessible 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 workspace and equipment.
  • Check leveling of the equipment.
  • Verify power supply is stable and within specifications.
See also  GC-MS (CAL-0125) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability: ISO17025
  • Certificate validity check: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be 5, including endpoints (0 mL and 10 mL) and midpoints (5 mL). Each point will have 3 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 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 any measurements are OOT, 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 accordingly.

10. Acceptance Criteria & Calculations

The acceptance criteria for the Volumetric Flask 10 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 the acceptance criteria. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed before returning to service.
  • QA disposition placeholders: [TBD].

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records as per company policy.
  • 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

  • Environmental controls verified
  • Equipment warmed up
  • Workspace cleanliness confirmed
  • Leveling checked
  • Power supply stable

Annexure C: Example Label Text

Calibration Date: [TBD]
Due Date: [TBD]
Calibrated By: [TBD]
Status: [TBD]

See also  Bioreactor Pressure Sensor (CAL-0303) - 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-0032 Volumetric Flask 10 mL Volumetric Flask QC Glassware Room Solution prep Volume mL 0 – 10 Class A 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 mL
  • 25%: 2.5 mL
  • 50%: 5.0 mL
  • 75%: 7.5 mL
  • Maximum: 10 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]
2.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
5.0 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
7.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
10 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 ambient temperature for at least 30 minutes.
  3. Performing Readings:
    • Fill the flask to each test point (0 mL, 2.5 mL, 5.0 mL, 7.5 mL, 10 mL).
    • Take three replicate readings for each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated errors against the acceptance criteria.
  6. Documentation: Record all observations and results in the calibration log.

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-0032 Volumetric Flask 10 mL QC Glassware Room Volume 0 – 10 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 procedures
  • [ ] Ensure the flask is leveled properly
  • [ ] Check validity of reference standards
  • [ ] Confirm 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 for results
See also  Liquid Filler Volume Calibration (CAL-0213) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the volumetric flask
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation from acceptance criteria
  • [ ] Trigger impact review process

As Left Verification

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

Documentation & Closure

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

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Deviation Impact Assessment

Event Summary Details
Asset Volumetric Flask 10 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-0032 Volumetric Flask 10 mL Volumetric Flask QC Glassware Room [TBD] [TBD] [TBD] Volume (0 – 10 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
1 [TBD] Class A
2 [TBD] Class A
3 [TBD] Class A
4 [TBD] Class A
5 [TBD] Class A

As Left Results

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

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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