Calibration Documents: Dissolution Tester Apparatus 1/2 (CAL-0130)

Asset ID	CAL-0130
Equipment	Dissolution Tester Apparatus 1/2
Equipment Type	Dissolution Tester
Department	QC
Area/Location	Instrument Room
Process Use	Dissolution
Parameter	Temperature
Units	°C
Range Min	20
Range Max	50
Acceptance Criteria	±0.5°C
Calibration Frequency (days)	365
Calibration Type	External
Traceability	ISO17025

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Calibration SOP

1. Purpose

The calibration of the Dissolution Tester Apparatus 1/2 is performed to ensure accurate temperature measurements during dissolution testing. This is critical for maintaining patient safety, ensuring batch quality, and preserving data integrity. Accurate temperature control is essential to meet regulatory requirements and to avoid any potential risks associated with inaccurate dissolution results.

2. Scope

• Asset ID: CAL-0130
• Equipment Name/Type: Dissolution Tester Apparatus 1/2 / Dissolution Tester
• Department/Area: QC / Instrument Room
• Process Use: Dissolution
• Parameter: Temperature
• Range: 20°C to 50°C
• Units: °C
• Calibration Frequency: 365 days

3. Definitions

• Calibration: The process of verifying and adjusting the accuracy of a measurement instrument.
• Verification: The confirmation 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 a measurement falls outside the specified 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 an instrument’s performance between full 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 required.

6. Safety & Preconditions

• Ensure environmental controls are in place (temperature, humidity).
• Allow for warm-up/stabilization of the equipment as per manufacturer guidelines.
• Maintain cleanliness of the instrument and surrounding area.
• Check that the instrument is level before calibration.
• Verify power supply is stable and within specifications.

7. Standards & Tools

• Reference standards required: [TBD]
• Traceability statement: ISO17025
• Certificate validity check: [TBD]
• Standard ID placeholders: [TBD]

8. Calibration Strategy

The calibration will follow the As Found and As Left logic. A minimum of 5 points will be taken across the specified range of 20°C to 50°C, including endpoints and midpoints. It is recommended to take 3 replicate readings at each point to ensure accuracy, unless otherwise specified.

9. Step-by-Step Procedure

1. Preparation: Gather all necessary tools and reference standards.
2. Stabilization: Allow the instrument to stabilize at the operating temperature.
3. As Found checks and data capture: Record the temperature readings at the defined points.
4. Adjustment rules: If any readings are OOT, escalate for adjustment as per SOP.
5. As Left verification: Confirm that the instrument is within the acceptance criteria after adjustments.
6. Labeling + documentation completion: Ensure all calibration records are filled out accurately.

Record all raw observations contemporaneously to maintain ALCOA+ compliance.

10. Acceptance Criteria & Calculations

The acceptance criteria for the temperature parameter is ±0.5°C. The error calculation formula is:

Error = Observed Value – True Value

Pass/Fail Logic: If the absolute value of the error is within the acceptance criteria, 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.
• Impact assessment trigger: Define the 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: Maintain detailed records of all calibration activities.
• Calibration report/certificate filing: Store all calibration certificates securely.
• 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
• Instrument warm-up completed
• Cleanliness checked
• 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-0130	Dissolution Tester Apparatus 1/2	Dissolution Tester	QC	Instrument Room	Dissolution	Temperature	°C	20 – 50	±0.5°C	365 days	External	ISO17025

Environmental Conditions

Temperature: [TBD]

Relative Humidity: [TBD]

Vibration: [TBD]

Drafts: [TBD]

Test Point Selection

• Minimum: 20°C
• 25%: 27.5°C
• 50%: 35°C
• 75%: 42.5°C
• Maximum: 50°C

Results Table

Test Point	Ref Value	Observed (As Found)	Error	Limit	Pass/Fail	Observed (As Left)	Error	Pass/Fail
20°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
27.5°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
35°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
42.5°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]
50°C	[TBD]	[TBD]	[TBD]	±0.5°C	[TBD]	[TBD]	[TBD]	[TBD]

Stepwise Instructions

1. Preparation: Ensure the Dissolution Tester is clean and calibrated prior to use.
2. Stabilization: Allow the equipment to stabilize at the ambient temperature for at least 30 minutes.
3. Performing Readings:
   • Set the temperature to each test point.
   • Allow the temperature to stabilize for 10 minutes.
   • 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.
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 immediately.
• Notify the supervisor and quality assurance.
• 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-0130	Dissolution Tester Apparatus 1/2	QC	Instrument Room	Temperature	20 – 50 °C	±0.5°C	365 days	ISO17025

Pre-calibration

• [ ] Verify environmental conditions are within specified limits
• [ ] Ensure equipment has warmed up adequately
• [ ] Clean the apparatus as per SOP
• [ ] Level the equipment
• [ ] Confirm validity of reference standards
• [ ] Logbook is ready for entries

As Found Execution

• [ ] Set the temperature to specified setpoints
• [ ] Perform necessary repeats for accuracy
• [ ] Record all raw data accurately
• [ ] Perform calculations as required

OOT Immediate Actions

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

As Left Verification

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

Documentation & Closure

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

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

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Deviation Impact Assessment

Event Summary
Asset: Dissolution Tester Apparatus 1/2 Date: [TBD] Discovered By: [TBD] Document References: [TBD] As Found Results Summary: [TBD]

Immediate Containment Checklist

• Stop use of the affected 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-0130	Dissolution Tester Apparatus 1/2	Dissolution Tester	QC	Instrument Room	[TBD]	[TBD]	[TBD]	Temperature: 20 – 50 °C	±0.5°C

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 (°C)	Acceptance Criteria
1	[TBD]	±0.5°C
2	[TBD]	±0.5°C
3	[TBD]	±0.5°C
4	[TBD]	±0.5°C
5	[TBD]	±0.5°C

As Left Results

Test Point	Measured Value (°C)	Acceptance Criteria
1	[TBD]	±0.5°C
2	[TBD]	±0.5°C
3	[TBD]	±0.5°C
4	[TBD]	±0.5°C
5	[TBD]	±0.5°C

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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