Procedure for Adhesion Testing in Transdermal Patches
1) Purpose
The purpose of this SOP is to outline the procedure for testing the adhesion strength of transdermal patches to ensure proper attachment to the skin surface during use.
2) Scope
This SOP applies to all transdermal patches requiring adhesion testing as part of quality control measures to assess product performance and adherence to specifications.
3) Responsibilities
Quality Control (QC) Department: Responsible for performing adhesion testing.
Quality Assurance (QA) Department: Responsible for review and approval of adhesion testing procedures and results.
Manufacturing Department: Responsible for providing transdermal patch samples and support during testing.
4) Procedure
4.1 Sample Preparation:
4.1.1 Cut the transdermal patch into appropriate sizes for testing.
4.1.2 Remove backing layers to expose the adhesive surface.
4.2 Test Apparatus Setup:
4.2.1 Attach the transdermal patch to a standardized testing surface or skin-mimicking substrate.
4.2.2 Ensure the testing apparatus is calibrated and positioned for accurate force measurement.
4.3 Adhesion Testing:
4.3.1 Apply a controlled force perpendicular to the patch surface using the testing apparatus.
4.3.2 Measure the force required to detach the patch from the substrate.
4.3.3 Record the maximum force exerted during detachment as a measure of adhesion strength.
4.4 Data Recording:
4.4.1 Record adhesion test results, including maximum force applied and any observations related to patch detachment.
4.4.2 Document any deviations from expected adhesion strength or specifications.
4.5 Reproducibility Testing:
4.5.1 Repeat adhesion testing on multiple patch samples to confirm consistency.
4.5.2 Ensure agreement in adhesion strength measurements across multiple tests.
4.6 Data Analysis:
4.6.1 Compile and review adhesion testing data, including numerical results and qualitative observations.
4.6.2 Analyze data against acceptance criteria and specifications.
4.7 Reporting:
4.7.1 Prepare an Adhesion Testing Report summarizing test procedures, results, and conclusions.
4.7.2 Include any corrective actions or recommendations based on adhesion testing findings.
4.7.3 Submit the report to QA for review and approval and maintain records as per facility procedures.
5) Abbreviations, if any
QC: Quality Control
QA: Quality Assurance
6) Documents, if any
Adhesion Testing Report
Sample Testing Data
7) Reference, if any
USP (insert appropriate reference for transdermal patches)
FDA Guidance for Industry – Container Closure Systems for Packaging Human Drugs and Biologics
8) SOP Version
Version 1.0