Sieve Shaker Speed (CAL-0136) – Calibration Documents

Calibration Documents: Sieve Shaker Speed (CAL-0136)

Asset ID CAL-0136
Equipment Sieve Shaker Speed
Equipment Type Sieve Shaker Speed
Department QC
Area/Location Particle Size
Process Use Sieving
Parameter Speed
Units RPM
Range Min 0
Range Max 400
Acceptance Criteria ±2%
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 Sieve Shaker Speed is performed to ensure the accuracy of the speed measurement, which is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate speed measurements are essential in the sieving process to achieve consistent particle size distribution, thereby minimizing risks associated with product variability.

2. Scope

  • Asset ID: CAL-0136
  • Equipment Name/Type: Sieve Shaker Speed
  • Department/Area: QC / Particle Size
  • Process Use: Sieving
  • Parameter: Speed
  • Range: 0 – 400 RPM
  • Units: RPM
  • 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 specifications.
  • As Found: The condition of the instrument prior to any adjustments made during calibration.
  • As Left: The condition of the instrument after adjustments have been made and verified.
  • 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 range of values within which the true value of a measurement lies.
  • Intermediate Check: A periodic verification 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: Responsible for performing the calibration and documenting results.
  • QC/QA Reviewer: Responsible for reviewing calibration documentation and ensuring compliance.
  • Owner Department: Responsible for ensuring the equipment is available and in good condition for calibration.
  • External Service Provider: Responsible for conducting the calibration as per the external calibration type.

6. Safety & Preconditions

  • Ensure environmental controls are in place (temperature, humidity).
  • Allow equipment to warm up and stabilize before calibration.
  • Maintain cleanliness of the equipment and surrounding area.
  • Ensure the equipment is level and stable during calibration.
  • Check power supply for stability and reliability.
See also  O2 Analyzer (Gas line) (CAL-0100) - Calibration Documents

7. Standards & Tools

  • Reference Standards: [TBD]
  • Traceability Statement: ISO17025
  • Certificate Validity Check: Ensure calibration certificates are current and valid.
  • Standard ID: [TBD]

8. Calibration Strategy

Calibration will follow the As Found then As Left logic. The minimum number of points for calibration will include at least 5 points across the range of 0 to 400 RPM, including endpoints and midpoints. It is recommended to take 3 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 Sieve Shaker Speed to warm up for [TBD] minutes.
  3. As Found checks and data capture: Measure the speed at defined points and record the data contemporaneously.
  4. Adjustment rules: If any readings are OOT, follow the adjustment protocol; if adjustments are not permitted, escalate the issue.
  5. As Left verification: After adjustments, recheck the speed and record the final values.
  6. Labeling + documentation completion: Ensure all calibration records are completed and labels are affixed to the equipment.

10. Acceptance Criteria & Calculations

The acceptance criteria for the Sieve Shaker Speed is ±2%. The error calculation formula is as follows:

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: [TBD]

11. Handling OOT / Failures

  • Immediate containment: Tag the equipment and stop its use.
  • Notification & deviation initiation: Notify the relevant personnel and initiate a deviation report.
  • Impact assessment trigger: Assess the impact on results/batches produced since the last calibration.
  • Recalibration after repair/adjustment: Schedule recalibration once issues are resolved.
  • QA disposition: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain a file of all 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 checked.
  • Equipment warm-up completed.
  • Calibration standards verified.
  • Documentation ready.

Annexure C: Example Label Text

Calibration Date: [TBD]

Due Date: [TBD]

See also  Burette 10 mL (CAL-0028) - Calibration Documents

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-0136 Sieve Shaker Speed Sieve Shaker Speed QC Particle Size Sieving Speed RPM 0 – 400 ±2% 365 days External ISO17025

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: 0 RPM
  • 25% of Range: 100 RPM
  • 50% of Range: 200 RPM
  • 75% of Range: 300 RPM
  • Maximum: 400 RPM

Results Table

Test Point Ref Value Observed (As Found) Error Limit Pass/Fail Observed (As Left) Error Pass/Fail
0 RPM 0 RPM [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
100 RPM 100 RPM [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
200 RPM 200 RPM [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
300 RPM 300 RPM [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]
400 RPM 400 RPM [TBD] [TBD] ±2% [TBD] [TBD] [TBD] [TBD]

Stepwise Instructions

  1. Preparation: Ensure the Sieve Shaker Speed is clean and properly set up in the QC area.
  2. Stabilization: Allow the equipment to stabilize for at least 30 minutes before calibration.
  3. Performing Readings: Take three replicate readings at each test point.
  4. Calculating Error: Calculate the error for each observed value against the reference value.
  5. Evaluation: Compare the calculated error to the acceptance criteria of ±2%.
  6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

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

  • Stop use of the equipment immediately.
  • Notify the QA department.
  • 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-0136 Sieve Shaker Speed QC Particle Size Speed 0 – 400 RPM ±2% 365 days ISO17025

Pre-calibration

  • [ ] Verify environmental conditions are within specified limits
  • [ ] Allow equipment to warm up as per SOP
  • [ ] Clean equipment according to cleaning procedures
  • [ ] Level equipment as required
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for recording

As Found Execution

  • [ ] Set initial speed setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  ICP-OES (CAL-0116) - Calibration Documents

OOT Immediate Actions

  • [ ] Tag out equipment if OOT is detected
  • [ ] Stop use of equipment immediately
  • [ ] Notify QA and relevant personnel
  • [ ] Document deviation in the logbook
  • [ ] Trigger impact review as per SOP

As Left Verification

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

Documentation & Closure

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

Acceptance Criteria: Results must be within ±2% of the specified range.

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

Out of Tolerance (OOT) Handling: Follow established procedures for OOT findings to ensure compliance and traceability.

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Deviation Impact Assessment

Event Summary
Asset: Sieve Shaker Speed
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-0136 Sieve Shaker Speed Sieve Shaker Speed QC Particle Size [TBD] [TBD] [TBD] Speed: 0 – 400 RPM ±2%

Conditions

Environment: [TBD]

Reference Standards

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

Results

As Found Results

Test Point Measured Value (RPM) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [TBD] [TBD]

As Left Results

Test Point Measured Value (RPM) Pass/Fail
1 [TBD] [TBD]
2 [TBD] [TBD]
3 [TBD] [TBD]
4 [TBD] [TBD]
5 [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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