Liquid Filler Volume Calibration (CAL-0213) – Calibration Documents

Calibration Documents: Liquid Filler Volume Calibration (CAL-0213)

Asset ID CAL-0213
Equipment Liquid Filler Volume Calibration
Equipment Type Piston Filler
Department Production
Area/Location Filling
Process Use Fill volume
Parameter Volume
Units mL
Range Min 0
Range Max 1000
Acceptance Criteria ±1%
Calibration Frequency (days) 180
Calibration Type In-house
Traceability ISO17025 glassware

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 Liquid Filler Volume Calibration (Piston Filler) is performed to ensure the accuracy of fill volumes, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate volume measurements prevent overfilling or underfilling, which can lead to product inconsistencies and potential regulatory non-compliance.

2. Scope

  • Asset ID: CAL-0213
  • Equipment Name/Type: Liquid Filler Volume Calibration / Piston Filler
  • Department/Area: Production / Filling
  • Process Use: Fill volume
  • Parameter: Volume
  • Range: 0 mL to 1000 mL
  • Units: mL
  • Calibration Frequency: Every 180 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The act of correcting a measurement instrument to bring it within specified limits.
  • 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 falls outside the specified acceptance criteria.
  • Drift: The gradual change in a measurement instrument’s output 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 check performed between calibrations to ensure continued 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 for compliance.
  • Owner Department: Ensure equipment is available and maintained.
  • External Service Provider: [TBD] (if applicable)

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 equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply stability.
See also  Raman Spectrometer (CAL-0112) - Calibration Documents

7. Standards & Tools

  • Reference Standards: ISO17025 glassware
  • Traceability Statement: Calibration performed using traceable standards.
  • Certificate Validity Check: Ensure all standards are within their validity period.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found and As Left logic:

  • Minimum number of points: 5 points including endpoints (0 mL, 1000 mL) and midpoints (e.g., 250 mL, 500 mL, 750 mL).
  • Replicate readings: Perform 3 repeats at each point as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the equipment to stabilize as per guidelines.
  3. As Found checks and data capture: Measure the fill volume at each defined point and record results contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is detected, follow escalation procedures; adjustments are only to be made if allowed.
  5. As Left verification: Measure again after adjustments to confirm compliance.
  6. Labeling + documentation completion: Ensure all records are filled out accurately and completely.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% of the target volume.

Error Calculation Formula: Error (%) = (Observed Value – Target Value) / Target Value × 100

Pass/Fail Logic: If the absolute error is within ±1%, the measurement passes; otherwise, it fails.

Rounding Rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Inform relevant personnel.
  • 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 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

  • Environmental controls verified
  • Equipment warm-up completed
  • Cleanliness confirmed
  • Leveling checked
  • Power supply stable

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

Calibrated By: [TBD]

See also  Temperature Data Logger (Single-use mapping) (CAL-0055) - Calibration Documents

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-0213 Liquid Filler Volume Calibration Piston Filler Production Filling Fill volume Volume mL 0 – 1000 ±1% 180 days In-house ISO17025 glassware

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Calibration will be performed at the following test points:

  • 0 mL (Min)
  • 250 mL (25%)
  • 500 mL (50%)
  • 750 mL (75%)
  • 1000 mL (Max)

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mL [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
250 mL [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
500 mL [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
750 mL [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
1000 mL [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the equipment is clean and free from any contaminants.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before calibration.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each test point using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±1%.
  6. Documentation: Record all observations and results in the results table.

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance.
  • 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-0213 Liquid Filler Volume Calibration Production Filling Volume 0 – 1000 mL ±1% 180 days ISO17025 glassware

Pre-calibration

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

As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Photo-stability Chamber UV (CAL-0185) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all results 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 logbook

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

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Deviation Impact Assessment

Event Summary
Asset: CAL-0213
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-0213 Liquid Filler Volume Calibration Piston Filler Production Filling [TBD] [TBD] [TBD] Volume: 0 – 1000 mL ±1%

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (mL) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (mL) Deviation
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: ___________

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