Standard Operating Procedure for Operation of Tablet Hardness Tester
Purpose
The purpose of this SOP is to provide comprehensive guidelines for the proper operation of the tablet hardness tester in pharmaceutical manufacturing. It ensures accurate and consistent measurement of tablet hardness, which is a critical quality parameter for tablet production.
Scope
This SOP applies to all personnel involved in operating the tablet hardness tester within the pharmaceutical company.
Responsibilities
- The Quality Assurance (QA) department is responsible for implementing and maintaining this SOP.
- The Production department is responsible for performing the tablet hardness testing.
Procedure
Preparation
- Ensure that the tablet hardness tester is clean and calibrated before starting the testing process.
- Verify that all required accessories, such as sample holders and cleaning tools, are available and in good condition.
- Check that the tablet hardness tester is connected to a stable power source and properly grounded.
Calibration
- Perform regular calibration of the tablet hardness tester according to the manufacturer’s instructions and schedule.
- Record the calibration details, including date, calibration standards used, and results obtained.
- Take corrective actions if any deviations are observed during the calibration process.
Operation
- Ensure that the tablet samples are representative of the batch to be tested.
- Place the tablet carefully into the sample holder of the hardness tester.
- Adjust the tablet holder and align the tablet surface parallel to the testing probe.
- Start the tablet hardness testing process as per the predetermined testing parameters.
- Record the hardness value displayed by the hardness tester for each tablet.
- If required, test multiple tablets from the same batch to obtain an average hardness value.
- Perform necessary cleaning of the tablet hardness tester after each testing session to prevent cross-contamination.
Post-Testing
- Review the hardness testing results and compare them with the predefined acceptance criteria.
- Document the hardness test results accurately in the appropriate records.
- Take appropriate action for any tablets that do not meet the specified hardness requirements.
- Notify the relevant departments if there are any quality issues or deviations.
Abbreviations
- QA: Quality Assurance
- SOP: Standard Operating Procedure
Documents
- Tablet Hardness Tester Calibration Log
- Tablet Hardness Test Results Log
References
No specific references are applicable for this SOP.
SOP Version
This is version 1.0 of the SOP for Operation of Tablet Hardness Tester.