Microbial Air Sampler Flow (CAL-0174) – Calibration Documents

Calibration Documents: Microbial Air Sampler Flow (CAL-0174)

Asset ID CAL-0174
Equipment Microbial Air Sampler Flow
Equipment Type Air Sampler
Department Microbiology
Area/Location Cleanroom
Process Use Micro air sampling
Parameter Flow
Units L/min
Range Min 0
Range Max 200
Acceptance Criteria ±5%
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 Microbial Air Sampler Flow is performed to ensure the accuracy of flow measurements during micro air sampling in the cleanroom environment. This calibration controls risks related to patient safety, batch quality, and data integrity by ensuring that the equipment operates within specified limits, thereby preventing erroneous results that could impact product quality.

2. Scope

  • Asset ID: CAL-0174
  • Equipment Name/Type: Microbial Air Sampler Flow / Air Sampler
  • Department/Area: Microbiology / Cleanroom
  • Process Use: Micro air sampling
  • Parameter: Flow
  • Range: 0 – 200 L/min
  • Units: L/min
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument to a standard of known accuracy.
  • Verification: The process of confirming that a measurement instrument meets specified requirements.
  • Adjustment: The process of modifying a measurement 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 results fall outside the specified acceptance criteria.
  • Drift: The gradual change in a measurement 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 of the 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 document results.
  • QC/QA Reviewer: Review calibration documentation and ensure compliance.
  • Owner Department: Ensure equipment is available and maintained.
  • External Service Provider: Conduct external calibrations as required.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow warm-up/stabilization time for the equipment.
  • Maintain cleanliness in the calibration area.
  • Check equipment leveling before use.
  • Verify power supply stability.
See also  Stability Chamber Controller Display Temp (CAL-0182) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability statement: ISO17025
  • Certificate validity check: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints within the specified range of 0 to 200 L/min. 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 documentation.
  2. Stabilization: Allow the equipment to stabilize as per manufacturer guidelines.
  3. As Found checks and data capture: Measure flow at defined points and record results contemporaneously (ALCOA+).
  4. Adjustment rules: If OOT is identified, follow adjustment protocols if permitted; otherwise, escalate to QA.
  5. As Left verification: Confirm that the equipment is within tolerance after adjustments.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment appropriately.

10. Acceptance Criteria & Calculations

Acceptance criteria for flow measurements is ±5% of the target value. The error calculation formula is:

Error (%) = (Measured Value – Target Value) / Target Value × 100

Pass/Fail logic: If the error falls within ±5%, the result is a pass; otherwise, it is a fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Notify relevant personnel and initiate deviation process.
  • Impact assessment trigger: Assess impact on results/batches within the defined impact window.
  • Recalibration after repair/adjustment: Ensure recalibration is performed post-adjustment.
  • QA disposition placeholders: [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 warm-up completed
  • Calibration area cleanliness confirmed
  • Equipment leveled
  • Power supply checked

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-0174 Microbial Air Sampler Flow Air Sampler Microbiology Cleanroom Micro air sampling Flow L/min 0 – 200 ±5% 365 days External ISO17025
See also  Chromatography Skid Flow Meter (CAL-0311) - Calibration Documents

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Min: 0 L/min
  • 25%: 50 L/min
  • 50%: 100 L/min
  • 75%: 150 L/min
  • Max: 200 L/min

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 L/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
50 L/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
100 L/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
150 L/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]
200 L/min [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the equipment is clean and calibrated according to the last calibration record.
  2. Stabilization: Allow the equipment to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicates at each test point and record the observed 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 ±5%.
  6. Documentation: Complete the results table and ensure all data is recorded accurately to maintain ALCOA+ principles.

Deviation Instruction for OOT

If any observed value falls outside the acceptance criteria:

  • Stop use of the equipment immediately.
  • Notify the supervisor and quality assurance (QA) team.
  • 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-0174 Microbial Air Sampler Flow Microbiology Cleanroom Flow 0 – 200 L/min ±5% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean the equipment as per cleaning procedure
  • [ ] Ensure equipment is level
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for entries

As Found Execution

  • [ ] Set equipment to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results

OOT Immediate Actions

  • [ ] Tag out equipment if out of tolerance
  • [ ] Stop use of equipment immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in logbook
  • [ ] Trigger impact review as per SOP
See also  Photo-stability Chamber UV (CAL-0185) - Calibration Documents

As Left Verification

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

Documentation & Closure

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

Acceptance Criteria: Ensure all measurements are within ±5% of specified range.

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

Out of Tolerance (OOT) Handling: Follow immediate actions as outlined above to ensure compliance and safety.

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Deviation Impact Assessment

Event Summary Details
Asset Microbial Air Sampler Flow
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

Root Cause: [TBD]

CAPA Plan

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

QA Disposition

Release/Hold/Re-test/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-0174 Microbial Air Sampler Flow Air Sampler Microbiology Cleanroom [TBD] [TBD] [TBD] Flow: 0 – 200 L/min ±5%

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

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

As Left Results

Test Point Measured Value (L/min) Acceptance Criteria Pass/Fail
1 [TBD] ±5% [TBD]
2 [TBD] ±5% [TBD]
3 [TBD] ±5% [TBD]
4 [TBD] ±5% [TBD]
5 [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: ____________

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