Load Cell (Bin blender) (CAL-0012) – Calibration Documents

Calibration Documents: Load Cell (Bin blender) (CAL-0012)

Asset ID CAL-0012
Equipment Load Cell (Bin blender)
Equipment Type Load Cell
Department Production
Area/Location Blending
Process Use Mass monitoring
Parameter Weight
Units kg
Range Min 0
Range Max 500
Acceptance Criteria ±0.1%
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 Load Cell (Bin blender) is performed to ensure accurate mass monitoring during the blending process. This calibration controls risks related to accuracy, patient safety, batch quality, and data integrity, thereby ensuring compliance with Good Manufacturing Practices (GMP).

2. Scope

  • Asset ID: CAL-0012
  • Equipment Name/Type: Load Cell (Bin blender)
  • Department/Area: Production / Blending
  • Process Use: Mass monitoring
  • Parameter: Weight
  • Range: 0 kg to 500 kg
  • Units: kg
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement device to a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement device operates within specified limits.
  • Adjustment: The act of modifying a measurement device to bring it within specified limits.
  • As Found: The condition of the measurement device prior to any adjustments.
  • As Left: The condition of the measurement device after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement device does not meet the specified 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 that characterizes the range of values within which the true value of a measurement lies.
  • Intermediate Check: A verification process conducted 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 documentation and ensure compliance.
  • Owner Department: Ensure equipment is available and in good condition for calibration.
  • External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow for warm-up/stabilization of the equipment as per manufacturer guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment before calibration.
  • Verify power supply stability and functionality.
See also  Inline Conductivity Sensor (PW) (CAL-0094) - 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.

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of test points will be five, including endpoints (0 kg and 500 kg) and midpoints. Each point will have three replicate readings to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Load Cell to stabilize before taking measurements.
  3. As Found checks and data capture: Record initial readings at designated points.
  4. Adjustment rules: If OOT is identified, escalate for adjustment as per SOP.
  5. As Left verification: Confirm that the Load Cell is within acceptance criteria after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment appropriately.

Record all raw observations contemporaneously to ensure data integrity (ALCOA+).

10. Acceptance Criteria & Calculations

The acceptance criteria for the Load Cell calibration is ±0.1%. The error calculation formula is:

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

Pass/Fail Logic: If the calculated error falls within ±0.1%, the calibration passes; otherwise, it fails.

Rounding rule: [TBD]

11. Handling OOT / Failures

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

12. Records & Retention

  • Logbook entries: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records of calibration certificates.
  • 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 clean and leveled
  • Power supply checked
  • Calibration standards available

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

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-0012 Load Cell (Bin blender) Load Cell Production Blending Mass monitoring Weight kg 0 – 500 ±0.1% 365 days External ISO17025
See also  CO2 Analyzer (Incubator) (CAL-0099) - Calibration Documents

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 kg
  • 25% of Range: 125 kg
  • 50% of Range: 250 kg
  • 75% of Range: 375 kg
  • Maximum: 500 kg

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
125 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
250 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
375 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]
500 kg [TBD] [TBD] [TBD] ±0.1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the load cell is clean and free from any obstructions. Verify that the calibration equipment is functioning properly.
  2. Stabilization: Allow the load cell to stabilize for at least [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point and record the values.
  4. Calculating Error: Calculate the error for each observed value using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±0.1%.
  6. Documentation: Complete the results table and ensure all data is recorded accurately.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • 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 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-0012 Load Cell (Bin blender) Production Blending Weight 0 – 500 kg ±0.1% 365 days ISO17025

1) Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the equipment and surrounding area
  • [ ] Level the load cell as per manufacturer instructions
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for entries

2) As Found Execution

  • [ ] Set initial setpoints for calibration
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results

3) OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation and OOT findings
  • [ ] Trigger impact review as per SOP
See also  Inline Temp Sensor (Reactor Jacket) (CAL-0200) - Calibration Documents

4) As Left Verification

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

5) Documentation & Closure

  • [ ] Update equipment label with new calibration date
  • [ ] Attach calibration certificate to logbook
  • [ ] Obtain reviewer sign-off on calibration records
  • [ ] Update next due date for calibration

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

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Deviation Impact Assessment

Event Summary
Asset: Load Cell (Bin blender)
Date: [TBD]
Discovered By: [TBD]
Document References: [TBD]
As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the affected equipment
  • Label/tag the equipment 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-0012 Load Cell (Bin blender) Load Cell Production Blending [TBD] [TBD] [TBD] Weight (0 – 500 kg) ±0.1%

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 (kg) Acceptance Criteria Pass/Fail
0 kg [TBD] ±0.1% [TBD]
100 kg [TBD] ±0.1% [TBD]
200 kg [TBD] ±0.1% [TBD]
300 kg [TBD] ±0.1% [TBD]
500 kg [TBD] ±0.1% [TBD]

As Left Results

Test Point Measured Value (kg) Acceptance Criteria Pass/Fail
0 kg [TBD] ±0.1% [TBD]
100 kg [TBD] ±0.1% [TBD]
200 kg [TBD] ±0.1% [TBD]
300 kg [TBD] ±0.1% [TBD]
500 kg [TBD] ±0.1% [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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