Rotameter (Gas) (CAL-0084) – Calibration Documents

Calibration Documents: Rotameter (Gas) (CAL-0084)

Asset ID CAL-0084
Equipment Rotameter (Gas)
Equipment Type Rotameter
Department Utilities
Area/Location Gas Room
Process Use Gas flow
Parameter Flow
Units L/min
Range Min 0
Range Max 50
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 Rotameter (Gas) is performed to ensure accurate measurement of gas flow, which is critical for maintaining process integrity, ensuring patient safety, and guaranteeing batch quality. Accurate flow measurements directly impact the reliability of the processes that depend on gas flow, thereby controlling risks associated with inaccurate dosing and potential product quality issues.

2. Scope

  • Asset ID: CAL-0084
  • Equipment Name/Type: Rotameter (Gas)
  • Department/Area: Utilities / Gas Room
  • Process Use: Gas flow
  • Parameter: Flow
  • Range: 0 – 50 L/min
  • Units: L/min
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of comparing a measurement instrument against a known standard to determine its 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 falls outside the specified acceptance criteria.
  • Drift: The gradual change in the output of a measurement 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 periodic check of the instrument’s performance between 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 results and documentation.
  • Owner Department: Ensure equipment is available and accessible 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 for warm-up/stabilization of the equipment as per manufacturer recommendations.
  • Maintain cleanliness of the area and equipment.
  • Check leveling of the equipment to ensure accurate measurements.
  • Verify power supply checks are completed before calibration.
See also  Fluorescence Spectrophotometer (CAL-0114) - 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 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 50 L/min. It is recommended to take three replicate readings at each point to ensure accuracy and reliability.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and reference standards.
  2. Stabilization: Allow the Rotameter to stabilize before taking measurements.
  3. As Found checks and data capture: Record initial measurements and observations contemporaneously.
  4. Adjustment rules: If OOT is detected, follow the escalation process for adjustment if permitted.
  5. As Left verification: After adjustments, verify that the instrument is within tolerance.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

Acceptance criteria for the Rotameter (Gas) is ±5%. The error calculation formula is:

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

Pass/Fail logic: If the error falls within the acceptance criteria, the calibration is considered a pass; otherwise, it is a fail.

Rounding rule: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop its use.
  • Notification & deviation initiation: Notify relevant personnel of the OOT condition.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Schedule recalibration as necessary.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries: Maintain detailed logbook entries of all calibration activities.
  • Calibration report/certificate filing: Ensure all calibration reports and certificates are filed appropriately.
  • 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 clean and leveled
  • Power supply checked
  • Calibration standards available

Annexure C: Example Label Text

Calibrated 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-0084 Rotameter (Gas) Rotameter Utilities Gas Room Gas flow Flow L/min 0 – 50 ±5% 365 days External ISO17025
See also  Mass Flow Controller (Gas) (CAL-0083) - Calibration Documents

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 L/min
  • 25%: 12.5 L/min
  • 50%: 25 L/min
  • 75%: 37.5 L/min
  • Maximum: 50 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] ±5% [TBD] [TBD] [TBD] [TBD]
12.5 L/min [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]
25 L/min [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]
37.5 L/min [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]
50 L/min [TBD] [TBD] [TBD] ±5% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the rotameter is clean and free from any obstructions. Verify that the calibration equipment is available and functioning.
  2. Stabilization: Allow the rotameter to stabilize for a minimum of [TBD] minutes before taking readings.
  3. Performing Readings: Take three replicate readings at each test point. Record all 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 in the calibration log.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • Stop use of the rotameter.
  • Notify the supervisor immediately.
  • 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-0084 Rotameter (Gas) Utilities Gas Room Flow 0 – 50 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 procedures
  • [ ] Ensure equipment is leveled properly
  • [ ] Check validity of reference standards
  • [ ] Confirm logbook is ready for entries

As Found Execution

  • [ ] Set the required flow setpoints
  • [ ] Perform repeatability checks
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations for results
See also  Stability Chamber Controller Display RH (CAL-0183) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

  • [ ] Conduct post-adjustment checks
  • [ ] Confirm all results are within specified 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, and Accurate, with complete traceability.

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Deviation Impact Assessment

Event Summary
Asset: Rotameter (Gas)
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 tolerance
  • 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-0084 Rotameter (Gas) Rotameter Utilities Gas Room [TBD] [TBD] [TBD] Flow (0 – 50 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
0 [TBD] ±5% [TBD]
10 [TBD] ±5% [TBD]
20 [TBD] ±5% [TBD]
30 [TBD] ±5% [TBD]
40 [TBD] ±5% [TBD]
50 [TBD] ±5% [TBD]

As Left Results

Test Point Measured Value (L/min) Acceptance Criteria Pass/Fail
0 [TBD] ±5% [TBD]
10 [TBD] ±5% [TBD]
20 [TBD] ±5% [TBD]
30 [TBD] ±5% [TBD]
40 [TBD] ±5% [TBD]
50 [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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