Top Loading Balance 0.1 g (CAL-0004) – Calibration Documents

Calibration Documents: Top Loading Balance 0.1 g (CAL-0004)

Asset ID CAL-0004
Equipment Top Loading Balance 0.1 g
Equipment Type Top Loading Balance
Department Production
Area/Location Dispensing
Process Use Material dispensing
Parameter Weight
Units g
Range Min 0
Range Max 15000
Acceptance Criteria ±0.1 g
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 Top Loading Balance 0.1 g is performed to ensure accurate weight measurements during material dispensing in the Production department. 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-0004
  • Equipment Name/Type: Top Loading Balance 0.1 g
  • Department/Area: Production / Dispensing
  • Process Use: Material dispensing
  • Parameter: Weight
  • Range: 0 g to 15000 g
  • Units: g
  • 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 correcting a measurement device to bring it within specified limits.
  • As Found: The state of the equipment before any adjustments are made.
  • As Left: The state of the equipment 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 device’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 is asserted to lie.
  • Intermediate Check: A periodic check of the measurement device to ensure it remains within specified limits.

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 for compliance.
  • Owner Department: Ensure equipment is available and in proper condition for calibration.
  • External Service Provider: Conduct external calibration as per the defined schedule.

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 balance and surrounding area.
  • Check that the balance is level before use.
  • Verify power supply is stable and within specifications.
See also  Thermocouple Type K (CAL-0053) - Calibration Documents

7. Standards & Tools

  • Reference standards required: Calibration weights (certified).
  • Traceability: ISO17025
  • Check certificate validity of reference standards prior to use.
  • Standard ID: [TBD]

8. Calibration Strategy

The calibration will follow an As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints of the specified range (0 g to 15000 g). It is recommended to take three replicate readings at each point to ensure accuracy.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the balance to warm up for at least [TBD] minutes.
  3. As Found checks and data capture: Measure and record the weight using certified calibration weights.
  4. Adjustment rules: If OOT is detected, follow the adjustment protocol or escalate to QA.
  5. As Left verification: Re-measure to confirm adjustments bring the balance within acceptance criteria.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

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

10. Acceptance Criteria & Calculations

The acceptance criteria for the Top Loading Balance 0.1 g is ±0.1 g. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail logic: If the absolute value of the error is within the acceptance criteria, 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: Review affected results/batches within the defined impact window.
  • 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 for audit purposes.
  • e-Records if applicable: [TBD]
  • Label content requirements: Include calibrated date, due date, technician name, and calibration status.

13. Annexures

Annexure A: Calibration Data Sheet

Test Point 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
  • Balance leveled
  • Calibration weights checked

Annexure C: Example Label Text

Calibration Date: [TBD]

See also  UV-Vis Spectrophotometer (CAL-0110) - Calibration Documents

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-0004 Top Loading Balance 0.1 g Top Loading Balance Production Dispensing Material dispensing Weight g 0 – 15000 ±0.1 g 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 g
  • 25% of Range: 3750 g
  • 50% of Range: 7500 g
  • 75% of Range: 11250 g
  • Maximum: 15000 g

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 g [TBD] [TBD] [TBD] ±0.1 g [TBD] [TBD] [TBD] [TBD]
3750 g [TBD] [TBD] [TBD] ±0.1 g [TBD] [TBD] [TBD] [TBD]
7500 g [TBD] [TBD] [TBD] ±0.1 g [TBD] [TBD] [TBD] [TBD]
11250 g [TBD] [TBD] [TBD] ±0.1 g [TBD] [TBD] [TBD] [TBD]
15000 g [TBD] [TBD] [TBD] ±0.1 g [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the balance is clean and free from any obstructions.
  2. Stabilization: Allow the balance to warm up for at least 30 minutes before calibration.
  3. Performing Readings:
    • Place the calibration weights on the balance for each test point.
    • Record the observed weight for each test point in the results table.
    • Take three replicate readings for each test point and calculate the average.
  4. Calculating Error: Subtract the reference value from the observed value to determine the error.
  5. Evaluation: Compare the error against the acceptance criteria of ±0.1 g.
  6. Documentation: Complete the results table and ensure all entries are accurate and legible.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance.
  • 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-0004 Top Loading Balance 0.1 g Production Dispensing Weight 0 – 15000 g ±0.1 g 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specifications
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the balance and surrounding area
  • [ ] Level the balance using built-in leveling feet
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries
See also  Bottle Top Dispenser 0.5-5 mL (CAL-0026) - Calibration Documents

As Found Execution

  • [ ] Record initial setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

  • [ ] Tag out the equipment
  • [ ] Stop use of the balance
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review

As Left Verification

  • [ ] Perform 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

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Deviation Impact Assessment

Event Summary
Asset: Top Loading Balance 0.1 g
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 service
  • 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-0004 Top Loading Balance 0.1 g Top Loading Balance Production Dispensing [TBD] [TBD] [TBD] Weight (0 – 15000 g) ±0.1 g

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 (g) Pass/Fail
0 g [TBD] [TBD]
3000 g [TBD] [TBD]
6000 g [TBD] [TBD]
9000 g [TBD] [TBD]
12000 g [TBD] [TBD]

As Left Results

Test Point Measured Value (g) Pass/Fail
0 g [TBD] [TBD]
3000 g [TBD] [TBD]
6000 g [TBD] [TBD]
9000 g [TBD] [TBD]
12000 g [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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