Standard Operating Procedure for Adhesion Testing of Transdermal Patches

1) Purpose

The purpose of this SOP is to define the procedure for conducting adhesion testing of transdermal patches to ensure they meet the required adhesion strength and quality standards.

2) Scope

This SOP applies to all adhesion 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 adhesion 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 adhesion testing logbook.

4.2 Testing Equipment

• 4.2.1 Ensure the adhesion testing equipment (e.g., tensile tester) 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 Peel Adhesion Test:
  • 4.3.1.1 Cut the transdermal patch into standard-sized strips (e.g., 25 mm x 150 mm).
  • 4.3.1.2 Apply each strip to a clean, dry, stainless steel panel using a roller.
  • 4.3.1.3 Allow the patches to adhere for 10 minutes.
  • 4.3.1.4 Mount the panel on the tensile tester and peel the patch at a 180° angle at a speed of 300 mm/min.
  • 4.3.1.5 Record the peel force and calculate the average peel adhesion strength.
• 4.3.2 Tack Test:
  • 4.3.2.1 Use a probe tack tester to measure the tack of the transdermal patch.
  • 4.3.2.2 Place the patch on the test surface and bring the probe into contact with the patch.
  • 4.3.2.3 Apply a specified force for a set dwell time (e.g., 1 second) and then withdraw the probe at a constant speed.
  • 4.3.2.4 Record the maximum force required to detach the probe from the patch surface.
• 4.3.3 Shear Adhesion Test:
  • 4.3.3.1 Cut the transdermal patch into standard-sized strips (e.g., 25 mm x 25 mm).
  • 4.3.3.2 Apply each strip to a clean, dry, stainless steel panel using a roller.
  • 4.3.3.3 Allow the patches to adhere for 10 minutes.
  • 4.3.3.4 Hang a specified weight (e.g., 1 kg) from the free end of the patch and start a timer.
  • 4.3.3.5 Record the time taken for the patch to shear off from the panel.

4.4 Interpretation of Results

• 4.4.1 Compare the adhesion strength with the acceptance criteria.
• 4.4.2 Document any deviations or out-of-specification results.

4.5 Documentation

• 4.5.1 Record all test results in the adhesion testing data sheet.
• 4.5.2 Review and approve the adhesion 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

Adhesion Testing Logbook
Adhesion Testing Data Sheets

7) Reference, if any

ASTM D3330/D3330M – Standard Test Method for Peel Adhesion of Pressure-Sensitive Tape
ISO 8510-2 – Adhesives – Peel Test for a Flexible-Bonded-to-Rigid Test Specimen Assembly – Part 2: 180 Degree Peel

8) SOP Version

Version 1.0