Sterile Vial Filler Fill Volume (CAL-0214) – Calibration Documents

Calibration Documents: Sterile Vial Filler Fill Volume (CAL-0214)

Asset ID CAL-0214
Equipment Sterile Vial Filler Fill Volume
Equipment Type Filling Machine
Department Production
Area/Location Aseptic Filling
Process Use Fill volume
Parameter Volume
Units mL
Range Min 0
Range Max 50
Acceptance Criteria ±1%
Calibration Frequency (days) 180
Calibration Type In-house
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 Sterile Vial Filler Fill Volume is performed to ensure accurate fill volumes, which is critical for patient safety and batch quality. Accurate calibration controls the risk of underfilling or overfilling, thereby maintaining compliance with regulatory standards and ensuring data integrity throughout the production process.

2. Scope

  • Asset ID: CAL-0214
  • Equipment Name: Sterile Vial Filler Fill Volume
  • Equipment Type: Filling Machine
  • Department/Area: Production / Aseptic Filling
  • Process Use: Fill volume
  • Parameter: Volume
  • Range: 0 – 50 mL
  • Units: mL
  • Calibration Frequency: 180 days

3. Definitions

  • Calibration: The process of configuring an instrument to provide a result for a sample within an acceptable range.
  • Verification: The process of confirming that a device is functioning correctly against a standard.
  • Adjustment: The act of modifying a device to bring it within specified limits.
  • As Found: The condition of the equipment prior to any adjustments being made.
  • As Left: The condition of the equipment after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement exceeds the defined acceptance criteria.
  • Drift: The gradual change in the output of a measurement device 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 range of values within which the true value is asserted to lie.
  • Intermediate Check: A verification step performed between calibrations to ensure ongoing 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 results and ensure 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 before calibration.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment.
  • Verify power supply is stable and within specifications.
See also  Tablet Press Thickness Sensor (CAL-0211) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

The calibration will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints (0 mL and 50 mL) and midpoints (25 mL).
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the equipment to reach operational conditions.
  3. As Found checks and data capture: Measure fill volumes at defined points and record results contemporaneously.
  4. Adjustment rules: If OOT is found, follow adjustment procedures; if not allowed, escalate to QA.
  5. As Left verification: Confirm that adjustments bring the equipment within tolerance.
  6. Labeling + documentation completion: Ensure all records are filled out accurately and completely.

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% of the target fill volume.

Error calculation formula: Error (%) = (Observed Value – Target Value) / Target Value × 100

Pass/Fail logic: If the error is within ±1%, the result is a pass; otherwise, it is a fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Inform QA and document the deviation.
  • Impact assessment trigger: Define impact window and review of affected results/batches.
  • Recalibration after repair/adjustment: Ensure equipment is recalibrated 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: 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
  • Cleanliness checked
  • Leveling confirmed
  • Power supply stable

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

See also  Friability Tester (CAL-0134) - Calibration Documents

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-0214 Sterile Vial Filler Fill Volume Filling Machine Production Aseptic Filling Fill volume Volume mL 0 – 50 ±1% 180 days In-house ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 mL
  • 25% of Range: 12.5 mL
  • 50% of Range: 25 mL
  • 75% of Range: 37.5 mL
  • Maximum: 50 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]
12.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
25 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
37.5 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50 mL [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the equipment is clean and calibrated prior to use.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate measurements 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 in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance (QA) team.
  • 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-0214 Sterile Vial Filler Fill Volume Production Aseptic Filling Volume 0 – 50 mL ±1% 180 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Ensure equipment has warmed up adequately
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment properly
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

As Found Execution

  • [ ] Set the initial setpoints
  • [ ] Perform repeat measurements
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations
See also  Micropipette 20-200 µL (CAL-0022) - 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 all measurements are within acceptance limits

Documentation & Closure

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

Data Integrity (ALCOA+): Ensure all data recorded is Attributable, Legible, Contemporaneous, Original, and Accurate, with complete traceability.

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Deviation Impact Assessment

Event Summary
Asset: Sterile Vial Filler Fill Volume
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-0214 Sterile Vial Filler Fill Volume Filling Machine Production Aseptic Filling [TBD] [TBD] [TBD] Volume: 0 – 50 mL ±1%

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) Remarks
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (mL) Remarks
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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