Capsule Filler Dosing Disc Calibration (CAL-0212) – Calibration Documents

Calibration Documents: Capsule Filler Dosing Disc Calibration (CAL-0212)

Asset ID CAL-0212
Equipment Capsule Filler Dosing Disc Calibration
Equipment Type Fill Weight System
Department Production
Area/Location Encapsulation
Process Use Fill weight
Parameter Weight
Units mg
Range Min 0
Range Max 1500
Acceptance Criteria ±2%
Calibration Frequency (days) 180
Calibration Type In-house
Traceability Traceable weights

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 Capsule Filler Dosing Disc is performed to ensure the accuracy of fill weight measurements, which is critical for maintaining patient safety and ensuring batch quality. Accurate weight measurements directly impact the integrity of the product and compliance with regulatory standards, thereby controlling risks associated with inaccurate dosing and potential patient harm.

2. Scope

  • Asset ID: CAL-0212
  • Equipment Name: Capsule Filler Dosing Disc Calibration
  • Equipment Type: Fill Weight System
  • Department/Area: Production / Encapsulation
  • Process Use: Fill weight
  • Parameter: Weight
  • Range: 0 – 1500 mg
  • Units: mg
  • 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 an instrument meets specified requirements.
  • Adjustment: The act of altering the instrument to bring it into compliance with specified standards.
  • 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 defined acceptance criteria.
  • Drift: The gradual change in the output of an instrument 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 check performed between calibrations to ensure continued accuracy of the instrument.

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 results and documentation.
  • 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 for warm-up/stabilization of the equipment as per manufacturer guidelines.
  • Maintain cleanliness of the calibration area and equipment.
  • Check leveling of the equipment prior to calibration.
  • Verify power supply stability and functionality.
See also  Graduated Cylinder 10 mL (CAL-0040) - Calibration Documents

7. Standards & Tools

  • Reference Standards: Traceable weights
  • Traceability Statement: Calibration will be performed using traceable weights.
  • Certificate Validity Check: Ensure all reference weights are within valid calibration dates.
  • Standard ID: [TBD]

8. Calibration Strategy

The calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints within the specified range of 0 to 1500 mg. Each point will be measured in triplicate to ensure reliability of results.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the equipment to stabilize as per manufacturer recommendations.
  3. As Found checks and data capture: Measure the weight at each defined test point and record raw observations contemporaneously.
  4. Adjustment rules: If any measurement is OOT, escalate for further investigation and adjustment if permitted.
  5. As Left verification: Re-measure after adjustments to confirm compliance.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria for the calibration is ±2%. The error calculation formula is as follows:

Error (%) = [(Observed Value – True Value) / True Value] x 100

Pass/Fail logic: If the error falls within ±2%, the calibration is considered a pass; otherwise, it is a fail. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel 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 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
  • Cleanliness confirmed
  • Leveling checked
  • Power supply verified
See also  Micropipette 2-20 µL (CAL-0021) - Calibration Documents

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-0212 Capsule Filler Dosing Disc Calibration Fill Weight System Production Encapsulation Fill weight Weight mg 0 – 1500 ±2% 180 days In-house Traceable weights

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 mg
  • 25% of Range: 375 mg
  • 50% of Range: 750 mg
  • 75% of Range: 1125 mg
  • Maximum: 1500 mg

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mg [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
375 mg [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
750 mg [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
1125 mg [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
1500 mg [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure all equipment is clean and calibrated. Gather traceable weights for calibration.
  2. Stabilization: Allow the equipment to stabilize for [TBD] before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading as follows: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated error against the acceptance criteria of ±2%.
  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 QA department.
  • 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-0212 Capsule Filler Dosing Disc Calibration Production Encapsulation Weight 0 – 1500 mg ±2% 180 days Traceable weights

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has been warmed up for the required time
  • [ ] Clean the equipment as per SOP
  • [ ] Level the equipment appropriately
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the equipment to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  Micropipette 1-5 mL (CAL-0024) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out the equipment if out of tolerance (OOT)
  • [ ] Stop use of the equipment immediately
  • [ ] Notify relevant personnel
  • [ ] Document deviation
  • [ ] Trigger impact review process

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 is attributable, legible, contemporaneous, original, and accurate, with additional considerations for completeness and consistency.

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Deviation Impact Assessment

Event Summary
Asset: Capsule Filler Dosing Disc Calibration
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-0212 Capsule Filler Dosing Disc Calibration Fill Weight System Production Encapsulation [TBD] [TBD] [TBD] Weight (0 – 1500 mg) ±2%

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] Traceable weights

Results

As Found Results

Test Point Measurement (mg) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measurement (mg) Pass/Fail
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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