Airborne Particle Counter (CAL-0173) – Calibration Documents

Calibration Documents: Airborne Particle Counter (CAL-0173)

Asset ID CAL-0173
Equipment Airborne Particle Counter
Equipment Type Particle Counter
Department Microbiology/Cleanroom
Area/Location Cleanroom
Process Use Particle monitoring
Parameter Particles
Units particles
Range Min 0
Range Max 100000
Acceptance Criteria ISO14644 limits
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 Airborne Particle Counter is performed to ensure accurate monitoring of airborne particles within the cleanroom environment. This is critical for maintaining compliance with ISO14644 limits, thereby safeguarding patient safety, ensuring batch quality, and preserving data integrity.

2. Scope

  • Asset ID: CAL-0173
  • Equipment Name/Type: Airborne Particle Counter / Particle Counter
  • Department/Area: Microbiology/Cleanroom
  • Process Use: Particle monitoring
  • Parameter: Particles
  • Range: 0 – 100,000 particles
  • Units: particles
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a known standard to ensure accuracy.
  • Verification: The process of confirming that a measurement instrument is functioning correctly.
  • Adjustment: The act of modifying a measurement instrument to bring it into compliance with standards.
  • As Found: The condition of the instrument prior to any adjustments.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the instrument’s measurements fall outside the specified limits.
  • Drift: The gradual change in the 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 dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A verification process performed between calibrations to ensure continued accuracy.

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 in proper condition for calibration.
  • External Service Provider: Conduct external calibration as per schedule.

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 cleanroom environment.
  • Check leveling of the equipment.
  • Verify power supply stability.
See also  Water System Flow Transmitter (CAL-0322) - Calibration Documents

7. Standards & Tools

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

8. Calibration Strategy

Calibration will follow the As Found and As Left logic. The minimum number of test points will be five, including endpoints and midpoints. Each point will have three replicate readings as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and documentation.
  2. Stabilization: Allow the Airborne Particle Counter to warm up for the specified time.
  3. As Found checks and data capture: Record initial readings before any adjustments.
  4. Adjustment rules: If OOT is detected, escalate for further evaluation; adjustments should only be made if permitted.
  5. As Left verification: Confirm that the instrument is within tolerance after adjustments.
  6. Labeling + documentation completion: Ensure all calibration data is documented and labeled appropriately.

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

10. Acceptance Criteria & Calculations

Acceptance criteria are based on ISO14644 limits. The error calculation formula will be: Error = (Observed Value – True Value) / True Value * 100%. Pass/fail logic will be determined based on whether the error falls within acceptable limits. Rounding rule: [TBD].

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Inform relevant personnel of the OOT condition.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Maintain detailed records of all calibration activities.
  • Calibration report/certificate filing: Store all calibration certificates securely.
  • 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 confirmed
  • Leveling checked
  • Power supply verified

Annexure C: Example Label Text

Calibration Date: [TBD]
Due Date: [TBD]
Calibrated By: [TBD]
Status: [TBD]

See also  Karl Fischer Titrator (Coulometric) (CAL-0141) - Calibration Documents

⬆ Back to TOC

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-0173 Airborne Particle Counter Particle Counter Microbiology/Cleanroom Cleanroom Particle monitoring Particles particles 0 – 100000 ISO14644 limits 365 days External ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 particles
  • 25% of Range: 25000 particles
  • 50% of Range: 50000 particles
  • 75% of Range: 75000 particles
  • Maximum: 100000 particles

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
Minimum 0 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
25% 25000 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50% 50000 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
75% 75000 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
Maximum 100000 [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Airborne Particle Counter is clean and calibrated according to the manufacturer’s specifications.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point to ensure accuracy.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the observed values to the acceptance criteria (ISO14644 limits).
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any observed value is out of tolerance (OOT):

  • Stop use of the equipment.
  • Notify the supervisor immediately.
  • 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]

⬆ Back to TOC

Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0173 Airborne Particle Counter Microbiology/Cleanroom Cleanroom Particles 0 – 100000 particles ISO14644 limits 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per manufacturer guidelines
  • [ ] Clean the equipment according to SOP
  • [ ] Level the equipment as required
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation
See also  Burette 25 mL (CAL-0029) - Calibration Documents

As Found Execution

  • [ ] Set equipment to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations

OOT Immediate Actions

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

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm results 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, Accurate, and Complete.

⬆ Back to TOC

Deviation Impact Assessment

Event Summary
Asset: Airborne Particle Counter
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 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

Investigation Summary Placeholders: [TBD]

Root Cause: [TBD]

CAPA Plan

Action Owner Due Date Effectiveness Check
[TBD] [TBD] [TBD] [TBD]

QA Disposition

Release/Hold/Retest/Recall Triggers: [TBD]

⬆ Back to TOC

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-0173 Airborne Particle Counter Particle Counter Microbiology/Cleanroom Cleanroom [TBD] [TBD] [TBD] Particles: 0 – 100000 particles ISO14644 limits

Conditions

Environment: [TBD]

Reference Standards

Standard Name/ID Certificate No Due Date Traceability Statement
[TBD] [TBD] [TBD] ISO17025

Results

As Found Results

Test Point Result (particles)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [TBD]

As Left Results

Test Point Result (particles)
1 [TBD]
2 [TBD]
3 [TBD]
4 [TBD]
5 [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail overall]

Remarks: [TBD]

Signatures

Performed by: ____________________ Date: ___________

Checked by: ____________________ Date: ___________

Approved by: ____________________ Date: ___________

⬆ Back to TOC