Viscometer (Brookfield) (CAL-0230) – Calibration Documents

Calibration Documents: Viscometer (Brookfield) (CAL-0230)

Asset ID CAL-0230
Equipment Viscometer (Brookfield)
Equipment Type Viscometer
Department QC
Area/Location Chemistry Lab
Process Use Viscosity
Parameter Viscosity
Units cP
Range Min 1
Range Max 100000
Acceptance Criteria ±1%
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 Viscometer (Brookfield) is performed to ensure accurate measurement of viscosity, which is critical for maintaining product quality and ensuring patient safety. Accurate viscosity measurements are essential for batch consistency and compliance with regulatory standards, thus controlling risks associated with data integrity and product efficacy.

2. Scope

  • Asset ID: CAL-0230
  • Equipment Name/Type: Viscometer (Brookfield)
  • Department/Area: QC, Chemistry Lab
  • Process Use: Viscosity
  • Parameter: Viscosity
  • Range: 1 cP to 100000 cP
  • Units: cP
  • 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 before any adjustments are 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 established 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 a measurement lies.
  • Intermediate Check: A verification process conducted 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 good condition for calibration.
  • External Service Provider: Conduct external calibration as per the calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize as per manufacturer’s guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check that the equipment is leveled properly.
  • Verify power supply is stable and within specifications.
See also  Burette 10 mL (CAL-0028) - Calibration Documents

7. Standards & Tools

  • Reference standards required: [TBD]
  • Traceability Statement: Calibration traceable to ISO17025.
  • Check validity of calibration certificates: [TBD]
  • Standard ID placeholders: [TBD]

8. Calibration Strategy

The calibration process will follow the As Found and As Left logic:

  • Minimum number of points: At least 5 points including endpoints and midpoints within the range of 1 cP to 100000 cP.
  • Replicate readings at each point: 3 repeats as a best practice.

9. Step-by-Step Procedure

  1. Preparation: Gather all necessary tools and standards.
  2. Stabilization: Allow the viscometer to stabilize as per manufacturer’s instructions.
  3. As Found checks and data capture: Record initial measurements before any adjustments.
  4. Adjustment rules: If OOT is found, follow escalation procedures; adjustments should only be made if allowed.
  5. As Left verification: Record final measurements after adjustments.
  6. Labeling + documentation completion: Ensure all records are completed and labeled appropriately.

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

10. Acceptance Criteria & Calculations

Acceptance criteria: ±1% as per ASSET_JSON.

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

Pass/Fail logic: If error is within ±1%, mark as pass; otherwise, mark as fail.

Rounding rule placeholder: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag equipment and stop use.
  • Notification & deviation initiation: Notify relevant personnel.
  • Impact assessment trigger: Define impact window and review of 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 calibrations.
  • Calibration report/certificate filing: Store all calibration certificates securely.
  • e-Records if applicable: [TBD]
  • Label content requirements: Calibrated date, due date, by whom, 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 checked
  • Equipment warm-up completed
  • Cleanliness verified
  • Leveling confirmed
  • Power supply stable

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-0230 Viscometer (Brookfield) Viscometer QC Chemistry Lab Viscosity Viscosity cP 1 – 100000 ±1% 365 days External ISO17025
See also  Potentiometric Titrator (CAL-0142) - 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:

  • Minimum: 1 cP
  • 25% of Range: 25000 cP
  • 50% of Range: 50000 cP
  • 75% of Range: 75000 cP
  • Maximum: 100000 cP

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
1 cP [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
25000 cP [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
50000 cP [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
75000 cP [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]
100000 cP [TBD] [TBD] [TBD] ±1% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

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

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • 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]

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Calibration Checklist

Asset ID Equipment Dept Area Parameter Range Acceptance Frequency Traceability
CAL-0230 Viscometer (Brookfield) QC Chemistry Lab Viscosity 1 – 100000 cP ±1% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Ensure equipment has warmed up as per manufacturer guidelines
  • [ ] Clean the equipment according to SOP
  • [ ] Level the viscometer as required
  • [ ] Check validity of reference standards
  • [ ] Ensure calibration logbook is ready for documentation

As Found Execution

  • [ ] Set the viscometer to specified setpoints
  • [ ] Perform repeat measurements as per protocol
  • [ ] Record all raw data accurately
  • [ ] Perform necessary calculations for results
See also  Bioreactor Temperature Probe (CAL-0300) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

  • [ ] Conduct post-adjustment checks to confirm accuracy
  • [ ] Ensure all measurements are within specified limits

Documentation & Closure

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

Data Integrity (ALCOA+): Ensure all data is Attributable, Legible, Contemporaneous, Original, Accurate, and Complete.

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Deviation Impact Assessment

Event Summary Details
Asset Viscometer (Brookfield)
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 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-0230 Viscometer (Brookfield) Viscometer QC Chemistry Lab [TBD] [TBD] [TBD] Viscosity (1 – 100000 cP) ±1%

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 (cP) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (cP) Deviation
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

Measurement Uncertainty Statement: [TBD]

Statement of Conformity: [Pass/Fail]

Remarks: [TBD]

Signatures

Performed by: ______________________ Date: ____________

Checked by: ______________________ Date: ____________

Approved by: ______________________ Date: ____________

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