Peristaltic Pump Flow Calibration (CAL-0215) – Calibration Documents

Calibration Documents: Peristaltic Pump Flow Calibration (CAL-0215)

Asset ID CAL-0215
Equipment Peristaltic Pump Flow Calibration
Equipment Type Peristaltic Pump
Department Production
Area/Location Aseptic Filling
Process Use Flow
Parameter Flow
Units mL/min
Range Min 0
Range Max 500
Acceptance Criteria ±2%
Calibration Frequency (days) 180
Calibration Type In-house
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 Peristaltic Pump Flow Calibration is performed to ensure the accuracy of flow measurements, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate flow measurements prevent deviations that could compromise product quality and regulatory compliance.

2. Scope

  • Asset ID: CAL-0215
  • Equipment Name/Type: Peristaltic Pump
  • Department/Area: Production / Aseptic Filling
  • Process Use: Flow
  • Parameter: Flow
  • Range: 0 – 500 mL/min
  • Units: mL/min
  • Calibration Frequency: 180 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 meets specified requirements.
  • Adjustment: The act of modifying a measurement instrument to bring it into compliance with specifications.
  • 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 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 dispersion of the values attributed to a measured quantity.
  • Intermediate Check: A verification process conducted between calibrations to ensure ongoing 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 good condition for calibration.
  • External Service Provider: [TBD] (if applicable)

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 equipment and surrounding area.
  • Verify equipment is level and stable.
  • Check power supply for proper voltage and stability.
See also  Platform Scale 300 kg (CAL-0005) - Calibration Documents

7. Standards & Tools

  • Reference Standards Required: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure all reference standards are within their validity period.
  • Standard ID Placeholders: [TBD]

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, across the specified range of 0 to 500 mL/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 reference standards.
  2. Stabilization: Allow the pump to stabilize at operating conditions.
  3. As Found Checks and Data Capture: Measure flow at defined points and record data contemporaneously (ALCOA+).
  4. Adjustment Rules: If any measurement is OOT, follow adjustment protocols; if not allowed, escalate to QA.
  5. As Left Verification: Measure flow again to confirm adjustments are within specifications.
  6. Labeling + Documentation Completion: Complete all required documentation and label the equipment accordingly.

10. Acceptance Criteria & Calculations

The acceptance criteria for this calibration is ±2%. The error calculation formula is:

Error (%) = (Observed Value – True Value) / True Value × 100

Pass/Fail Logic: If the error is within ±2%, the calibration passes; otherwise, it fails.

Rounding Rule Placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and cease use.
  • Notification & deviation initiation: Notify QA and document the deviation.
  • Impact Assessment Trigger: Define 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: Document all calibration activities.
  • Calibration report/certificate filing: Maintain records as per company policy.
  • 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]

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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-0215 Peristaltic Pump Flow Calibration Peristaltic Pump Production Aseptic Filling Flow Flow mL/min 0 – 500 ±2% 180 days In-house ISO17025
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Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

  • Minimum: 0 mL/min
  • 25% of Range: 125 mL/min
  • 50% of Range: 250 mL/min
  • 75% of Range: 375 mL/min
  • Maximum: 500 mL/min

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 mL/min [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
125 mL/min [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
250 mL/min [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
375 mL/min [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
500 mL/min [TBD] [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the peristaltic pump is clean and calibrated equipment is available.
  2. Stabilization: Allow the pump to stabilize for [TBD] minutes before taking measurements.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each reading using the formula: Error = (Observed – Ref Value) / Ref Value * 100.
  5. Evaluation: Compare the calculated errors against the acceptance criteria of ±2%.
  6. Documentation: Record all observations in the results table and ensure data integrity (ALCOA+).

Deviation Instruction for OOT

If any reading is outside the acceptance criteria:

  • Stop use of the equipment.
  • Notify the supervisor immediately.
  • 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-0215 Peristaltic Pump Flow Calibration Production Aseptic Filling Flow 0 – 500 mL/min ±2% 180 days ISO17025

Pre-calibration

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

As Found Execution

  • [ ] Set the flow rate to specified setpoints
  • [ ] Perform repeat measurements as required
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
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OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: CAL-0215 – Peristaltic Pump Flow Calibration
Date: [TBD]
Discovered By: [TBD]
Document References: [TBD]
As Found Results Summary: [TBD]

Immediate Containment Checklist

  • Stop use of the equipment
  • Label/tag the equipment 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-0215 Peristaltic Pump Flow Calibration Peristaltic Pump Production Aseptic Filling [TBD] [TBD] [TBD] Flow: 0 – 500 mL/min ±2%

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 (mL/min) Pass/Fail
0 [TBD] [TBD]
100 [TBD] [TBD]
200 [TBD] [TBD]
300 [TBD] [TBD]
400 [TBD] [TBD]

As Left Results

Test Point Measured Value (mL/min) Pass/Fail
0 [TBD] [TBD]
100 [TBD] [TBD]
200 [TBD] [TBD]
300 [TBD] [TBD]
400 [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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