Nutraceutical Sieve Shaker Speed (CAL-0292) – Calibration Documents

Calibration Documents: Nutraceutical Sieve Shaker Speed (CAL-0292)

Asset ID CAL-0292
Equipment Nutraceutical Sieve Shaker Speed
Equipment Type Sieve Shaker
Department Nutraceutical 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 Nutraceutical Sieve Shaker Speed is performed to ensure the accuracy of the speed measurement, which is critical for maintaining patient safety and batch quality in the production of nutraceuticals. Accurate speed measurements are essential for achieving the desired particle size distribution, thereby ensuring product efficacy and compliance with regulatory standards. Calibration also supports data integrity by ensuring that measurements are reliable and traceable.

2. Scope

  • Asset ID: CAL-0292
  • Equipment Name/Type: Nutraceutical Sieve Shaker Speed / Sieve Shaker
  • Department/Area: Nutraceutical QC / Particle Size
  • Process Use: Sieving
  • Parameter: Speed
  • Range: 0 – 400 RPM
  • Units: RPM
  • Calibration Frequency: 365 days

3. Definitions

  • Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
  • Verification: The process of confirming that an instrument meets specified requirements.
  • Adjustment: The process of altering a measurement instrument to bring it into compliance with standards.
  • As Found: The condition of the instrument prior to any adjustments.
  • As Left: The condition of the instrument after adjustments have been made.
  • OOT (Out of Tolerance): A condition where the measurement exceeds the specified acceptance criteria.
  • Drift: The gradual change in a measurement instrument’s performance 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 is expected to lie.
  • Intermediate Check: A periodic verification of an instrument’s performance between scheduled 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 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 guidelines.
  • Maintain cleanliness of the equipment and surrounding area.
  • Check leveling of the equipment to ensure accurate measurements.
  • Verify power supply stability before calibration.
See also  Peristaltic Pump Flow Calibration (CAL-0215) - 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 then As Left logic. The minimum number of points for calibration will be five, including endpoints and midpoints of the specified range (0 – 400 RPM). 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 equipment to reach operational stability.
  3. As Found checks and data capture: Measure the speed at specified points and record observations contemporaneously (ALCOA+).
  4. Adjustment rules: If any readings are OOT, follow the adjustment protocol; if adjustments are not permitted, escalate to QA.
  5. As Left verification: Measure the speed again to confirm adjustments are within specifications.
  6. Labeling + documentation completion: Complete all required documentation and label the equipment with calibration details.

10. Acceptance Criteria & Calculations

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

Error (%) = [(Observed Value – True Value) / True Value] x 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 relevant personnel and initiate a deviation report.
  • Impact assessment trigger: Define the impact window and review affected results/batches.
  • Recalibration after repair/adjustment: Ensure recalibration is performed after any adjustments.
  • QA disposition placeholders: [TBD]

12. Records & Retention

  • Logbook entries: Document all calibration activities in the logbook.
  • Calibration report/certificate filing: Maintain a file of calibration reports and 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
  • Cleanliness checked
  • Leveling confirmed
  • Power supply stable
See also  Sieve Shaker Timer (CAL-0135) - Calibration Documents

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-0292 Nutraceutical Sieve Shaker Speed Sieve Shaker Nutraceutical QC Particle Size Sieving Speed RPM 0 – 400 ±2% 365 days External ISO17025

Environmental Conditions

Temperature: [TBD] °C

Relative Humidity: [TBD] %

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

Test points will be selected based on the following range:

  • Min: 0 RPM
  • 25%: 100 RPM
  • 50%: 200 RPM
  • 75%: 300 RPM
  • Max: 400 RPM

Results Table

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

Stepwise Instructions

  1. Preparation: Ensure the equipment is clean and free from any contaminants.
  2. Stabilization: Allow the sieve shaker to stabilize for a minimum of [TBD] minutes before calibration.
  3. Performing Readings: Take at least three replicate readings at each test point.
  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 ±2%.
  6. Documentation: Record all observations, calculations, and results in the calibration log.

Deviation Instruction for OOT

If any observed value is outside the acceptance criteria:

  • 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-0292 Nutraceutical Sieve Shaker Speed Nutraceutical 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 the equipment as per cleaning procedure
  • [ ] Level the equipment if necessary
  • [ ] Check validity of reference standards
  • [ ] Ensure logbook is ready for documentation

As Found Execution

  • [ ] Set the equipment to specified setpoints
  • [ ] Perform repeat measurements
  • [ ] Record raw data accurately
  • [ ] Perform necessary calculations
See also  Bottle Top Dispenser 0.5-5 mL (CAL-0026) - Calibration Documents

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

  • [ ] Update equipment label
  • [ ] Attach calibration certificate
  • [ ] 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 immediate actions as outlined above to ensure compliance and safety.

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Deviation Impact Assessment

Event Summary
Asset: Nutraceutical 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 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/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-0292 Nutraceutical Sieve Shaker Speed Sieve Shaker Nutraceutical 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 to 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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