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 criteria to determine compliance with quality standards.
4.5 Reporting and Documentation
- 4.5.1 Document test results in the appropriate records, including batch records, testing certificates, and quality control documentation.
- 4.5.2 Report any deviations from acceptance criteria and initiate investigation and corrective actions as required.
5) Abbreviations, if any
SOP: Standard Operating Procedure
QC: Quality Control
6) Documents, if any
Sampling Plans
Adhesive Testing Protocols
Quality Control Records
7) Reference, if any
ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
Pharmacopeial Forum: Adhesive Performance Testing
8) SOP Version
Version 1.0