Standard Operating Procedure for Thickness Testing of Transdermal Patches

1) Purpose

The purpose of this SOP is to define the procedure for conducting thickness testing of transdermal patches to ensure they meet the required specifications.

2) Scope

This SOP applies to all thickness testing activities for transdermal patches manufactured within the facility, including sample preparation, testing, and documentation.

3) Responsibilities

The Quality Control Department is responsible for performing and documenting thickness tests as per this SOP. The QC Manager ensures compliance with the procedure and regulatory requirements.

4) Procedure

4.1 Sample Preparation

• 4.1.1 Select samples of transdermal patches from the production batch.
• 4.1.2 Condition the samples at 25°C and 60% RH for at least 24 hours before testing.
• 4.1.3 Label the samples with the batch number and date of preparation.
• 4.1.4 Document the sample details in the thickness testing logbook.

4.2 Testing Equipment

• 4.2.1 Ensure the thickness gauge or micrometer is calibrated and in proper working condition.
• 4.2.2 Set up the equipment according to the manufacturer’s instructions.

4.3 Testing Procedures

• 4.3.1 Thickness Measurement:
  • 4.3.1.1 Place the transdermal patch on a flat, hard surface.
  • 4.3.1.2 Use the thickness gauge or micrometer to measure the thickness at five different points on the patch (e.g., center, top, bottom, left, right).
  • 4.3.1.3 Record each measurement to the nearest 0.01 mm.
  • 4.3.1.4 Calculate the average thickness of the patch.

4.4 Interpretation of Results

• 4.4.1 Compare the average thickness with the specified limits.
• 4.4.2 Document any deviations or out-of-specification results.

4.5 Documentation

• 4.5.1 Record all test results in the thickness testing data sheet.
• 4.5.2 Review and approve the thickness data before archiving.
• 4.5.3 Retain samples and records as per regulatory requirements.

5) Abbreviations, if any

RH: Relative Humidity

6) Documents, if any

Thickness Testing Logbook
Thickness Testing Data Sheets

7) Reference, if any

ASTM D645 – Standard Test Method for Thickness of Paper and Paperboard
ISO 4593 – Plastics – Film and Sheeting – Determination of Thickness by Mechanical Scanning

8) SOP Version

Version 1.0