Standard Operating Procedure for Adhesive Consistency Testing in Transdermal Patches

1) Purpose

The purpose of this SOP is to define procedures for testing the adhesive consistency of transdermal patches to ensure uniformity and adherence to quality standards.

2) Scope

This SOP applies to the adhesive consistency testing conducted on all batches of transdermal patches manufactured within the facility.

3) Responsibilities

The Quality Control (QC) Department is responsible for performing adhesive consistency testing as per this SOP. Production personnel assist in sample collection and providing necessary documentation.

4) Procedure

4.1 Sample Preparation

• 4.1.1 Collect representative samples of transdermal patches from each batch according to approved sampling plans.
• 4.1.2 Ensure samples are taken in a manner that preserves adhesive integrity and represents the entire batch.

4.2 Test Setup

• 4.2.1 Allow transdermal patch samples to equilibrate to specified testing conditions (e.g., temperature and humidity).
• 4.2.2 Prepare testing equipment, including a suitable apparatus for measuring adhesive properties (e.g., probe tack tester).

4.3 Adhesive Consistency Testing

• 4.3.1 Conduct adhesive consistency tests using validated methods and equipment.
• 4.3.2 Measure key adhesive properties, such as tackiness, peel strength, and shear strength, as applicable to product specifications.

4.4 Data Analysis

• 4.4.1 Record test results accurately, including all measurements and observations obtained during testing.
• 4.4.2 Compare test results against predefined acceptance