Calibration Documents: Load Cell (Loss-in-weight feeder) (CAL-0013)

Asset ID	CAL-0013
Equipment	Load Cell (Loss-in-weight feeder)
Equipment Type	Load Cell
Department	Production
Area/Location	Granulation
Process Use	Feed rate control
Parameter	Weight
Units	kg
Range Min	0
Range Max	50
Acceptance Criteria	±0.1%
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Load Cell (Loss-in-weight feeder) is performed to ensure accurate weight measurements for feed rate control in the granulation process. This calibration is critical to maintaining batch quality, ensuring patient safety, and preserving data integrity. Inaccurate weight measurements can lead to improper dosing, affecting product quality and compliance with Good Manufacturing Practices (GMP).

2. Scope

• Asset ID: CAL-0013
• Equipment Name/Type: Load Cell (Loss-in-weight feeder)
• Department/Area: Production / Granulation
• Process Use: Feed rate control
• Parameter: Weight
• Range: 0 kg to 50 kg
• Units: kg
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of an instrument against a known standard.
• Verification: Confirming that an instrument meets specified requirements.
• Adjustment: The process of altering an instrument to bring it into compliance with specifications.
• As Found: The condition of the instrument prior to any adjustments or corrections.
• As Left: The condition of the instrument after adjustments have been made.
• OOT (Out of Tolerance): A condition where the instrument’s measurement falls outside the defined acceptance criteria.
• Drift: The gradual change in an 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 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 maintain records.
• QC/QA Reviewer: Review calibration records and ensure compliance.
• Owner Department: Ensure equipment is available for calibration.
• External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow equipment to warm up and stabilize as per manufacturer specifications.
• Maintain cleanliness of the equipment and surrounding area.
• Check that the load cell is level before calibration.
• Verify power supply is stable and within specifications.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: Ensure all certificates are current and valid.

8. Calibration Strategy

Calibration will follow an As Found and As Left logic:

• Minimum number of points: At least 5 points including endpoints (0 kg and 50 kg) and midpoints (e.g., 25 kg).
• 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 load cell to stabilize in the calibration environment.
3. As Found checks and data capture: Record initial measurements at defined points.
4. Adjustment rules: If OOT is detected, follow the adjustment protocol; if not allowed, escalate to QA.
5. As Left verification: Confirm that the instrument is within acceptance criteria after adjustments.
6. Labeling + documentation completion: Complete all required documentation and label the equipment appropriately.

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

10. Acceptance Criteria & Calculations

Acceptance criteria: ±0.1%

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

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

Rounding rule: [TBD]

11. Handling OOT / Failures

• Immediate containment: Tag equipment and stop use until resolved.
• Notification & deviation initiation: Notify QA and initiate deviation report.
• Impact assessment trigger: Define 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 in accordance with company policy.
• 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 checked
• Leveling confirmed
• Power supply verified

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-0013	Load Cell (Loss-in-weight feeder)	Load Cell	Production	Granulation	Feed rate control	Weight	kg	0 – 50	±0.1%	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following values:

• Minimum: 0 kg
• 25% of Range: 12.5 kg
• 50% of Range: 25 kg
• 75% of Range: 37.5 kg
• Maximum: 50 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]
12.5 kg	[TBD]	[TBD]	[TBD]	±0.1%	[TBD]	[TBD]	[TBD]	[TBD]
25 kg	[TBD]	[TBD]	[TBD]	±0.1%	[TBD]	[TBD]	[TBD]	[TBD]
37.5 kg	[TBD]	[TBD]	[TBD]	±0.1%	[TBD]	[TBD]	[TBD]	[TBD]
50 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.
2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
3. Performing Readings: Take at least 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 ±0.1%.
6. Documentation: Record all observations and calculations in the results table.

Deviation Instruction for OOT

If any observed values fall outside the acceptance criteria:

• Stop use of the equipment immediately.
• Notify the supervisor and quality assurance (QA) team.
• Open a deviation report.
• Quarantine the 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-0013	Load Cell (Loss-in-weight feeder)	Production	Granulation	Weight	0 – 50 kg	±0.1%	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Ensure equipment has been warmed up for the required duration
• [ ] Clean the equipment and surrounding area
• [ ] Level the load cell properly
• [ ] Check validity of reference standards used for calibration
• [ ] Ensure calibration logbook is ready for documentation

As Found Execution

• [ ] Set the load cell to specified setpoints
• [ ] Perform multiple repeats for accuracy
• [ ] Record all raw data accurately
• [ ] Perform necessary calculations to determine deviations

OOT Immediate Actions

• [ ] Tag out the equipment if out of tolerance (OOT)
• [ ] Stop use of the load cell immediately
• [ ] Notify relevant personnel about the OOT condition
• [ ] Document the deviation in the logbook
• [ ] Trigger impact review process as necessary

As Left Verification

• [ ] Conduct post-adjustment checks to confirm accuracy
• [ ] Ensure all measurements are within acceptance limits

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Load Cell (Loss-in-weight feeder) 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 service
• Segregate impacted work areas

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-0013	Load Cell (Loss-in-weight feeder)	Load Cell	Production	Granulation	[TBD]	[TBD]	[TBD]	Weight (0 – 50 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
1	[TBD]	±0.1%	[TBD]
2	[TBD]	±0.1%	[TBD]
3	[TBD]	±0.1%	[TBD]
4	[TBD]	±0.1%	[TBD]
5	[TBD]	±0.1%	[TBD]

As Left Results

Test Point	Measured Value (kg)	Acceptance Criteria	Pass/Fail
1	[TBD]	±0.1%	[TBD]
2	[TBD]	±0.1%	[TBD]
3	[TBD]	±0.1%	[TBD]
4	[TBD]	±0.1%	[TBD]
5	[TBD]	±0.1%	[TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [TBD]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: _____________________ Date: ____________

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