mechanical property tests, and accurately record the results.

Quality Control (QC): Ensure that all mechanical property tests are conducted in accordance with Good Laboratory Practices (GLP) and regulatory requirements, and that the formulations meet the required quality standards for stability, strength, and integrity.

Project Managers: Coordinate the mechanical property testing process, ensuring that timelines are met and resources are efficiently allocated.

4) Procedure

The following steps outline the procedure for assessing the mechanical properties of pharmaceutical formulations:

1. Step 1: Define Formulation Requirements
   1. Identify the type of formulation to be tested (e.g., tablets, capsules, granules) and determine the mechanical properties that are most critical to the product (e.g., hardness, friability, disintegration time).
   2. Determine the desired mechanical characteristics based on the type of dosage form and its intended use. For example, tablets must withstand handling and packaging, while capsules must be robust enough for storage and transport.
   3. Establish acceptance criteria for each mechanical property based on regulatory guidelines (e.g., USP, EP) and the intended product specifications.
2. Step 2: Sample Preparation
   1. Prepare the required number of samples for testing, ensuring that they represent the formulation batch and are uniform in size, shape, and weight.
   2. Ensure that the samples are stored under controlled conditions (e.g., temperature, humidity) before testing to avoid any potential impact on the mechanical properties due to environmental factors.
3. Step 3: Testing of Mechanical Properties
   1. Tablet Hardness Testing:
      1. Use a tablet hardness tester to measure the breaking force required to break the tablet. Record the results in terms of kilogram-force (kgf) or Newtons (N).
      2. Test multiple tablets from the same batch to determine the consistency of the hardness across the formulation.
   2. Friability Testing:
      1. Use a friabilator to measure the friability (the tendency of the tablets to chip or break) by rotating the tablets in a drum for a specified time (e.g., 4 minutes) at a specific speed.
      2. After the rotation, weigh the tablets and calculate the percentage of weight loss. Ensure that the friability is within acceptable limits (usually less than 1%).
   3. Tensile Strength Testing:
      1. For soft or gel formulations (e.g., capsules, granules), measure the tensile strength of the formulation by testing its ability to withstand stress and pressure without breaking or deforming.
      2. Use a material testing machine to apply force until the sample breaks and record the force at failure.
   4. Compressibility Testing:
      1. Measure the compressibility of powder formulations by applying pressure to determine how the material behaves under compression.
      2. Record the changes in volume and calculate the compressibility index (Carr’s index) to assess the flowability and suitability of the formulation for processing.
4. Step 4: Data Collection and Analysis
   1. Record all test results, including the hardness values, friability percentage, tensile strength values, and compressibility index, for each sample tested.
   2. Analyze the data to determine if the formulation meets the desired mechanical properties and regulatory requirements. Compare the results with the established acceptance criteria.
   3. Identify any formulations that fail to meet the mechanical property specifications and recommend adjustments to the formulation or processing conditions.
5. Step 5: Documentation and Reporting
   1. Document all findings, including test methods, experimental conditions, and observed results, in a detailed report.
   2. Prepare a summary report that includes the evaluation of the mechanical properties of the formulations, any deviations from the expected results, and recommendations for further optimization or changes to the formulation.
   3. Ensure that all records are signed, dated, and stored in compliance with Good Laboratory Practices (GLP) and regulatory standards.
6. Step 6: Sample Disposal
   1. Dispose of any remaining test samples, testing materials, and chemicals according to safety protocols and environmental regulations.
   2. Ensure that hazardous materials, including excipients or chemicals, are disposed of in designated chemical waste containers.

5) Documents

The following documents should be maintained during the assessment of mechanical properties:

1. Mechanical Properties Testing Records
2. Tablet Hardness and Friability Testing Reports
3. Tensile Strength and Compressibility Testing Records
4. Data Analysis and Statistical Reports
5. Mechanical Properties Summary Report
6. Sample Disposal Records

6) Abbreviations

• API: Active Pharmaceutical Ingredient
• HPLC: High-Performance Liquid Chromatography
• USP: United States Pharmacopeia
• GLP: Good Laboratory Practices

7) References

References to regulatory guidelines and scientific literature that support this SOP:

• FDA Guidance for Pharmaceutical Development
• USP <1216> on Tablets
• ICH Q8(R2) Pharmaceutical Development

8) Version

Version 1.0: Initial version of the SOP.

9) Annexure

Mechanical Properties Testing Results Template

Formulation ID	Tablet Hardness (kg)	Friability (%)	Tensile Strength (N)	Compressibility Index (%)	Stability Results