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

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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.

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]

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

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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