Standard Operating Procedure for Use of Release Liners in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to define procedures for the selection, handling, and application of release liners used in the production of transdermal patches.

2) Scope

This SOP applies to the use of release liners during all stages of transdermal patch production, including coating, lamination, and final packaging, within the facility.

3) Responsibilities

The Production Department is responsible for implementing and overseeing the use of release liners as per this SOP. Quality Control (QC) personnel may conduct checks and inspections as required.

4) Procedure

4.1 Release Liner Selection

• 4.1.1 Select release liners based on product specifications, including release characteristics, thickness, and compatibility with adhesive and backing materials.
• 4.1.2 Verify that selected liners meet regulatory requirements and are sourced from approved suppliers.

4.2 Handling and Preparation

• 4.2.1 Handle release liners carefully to avoid wrinkles, tears, or contamination that could affect their release properties.
• 4.2.2 Ensure release liners are stored in controlled conditions (e.g., temperature and humidity) to maintain their integrity and performance.

4.3 Application and Integration

• 4.3.1 Prepare release liners for integration into patch production processes, ensuring compatibility with adhesive and backing materials.
• 4.3.2 Apply release liners according to validated procedures and batch-specific instructions to facilitate efficient patch manufacturing.

4.4 Quality Control Checks

• 4.4.1 Inspect release liners for defects, such as air bubbles, creases, or uneven application, that could compromise their function.
• 4.4.2 Conduct release force testing to measure the ease and consistency of liner removal from adhesive-coated patches.

4.5 Documentation and Reporting

• 4.5.1 Document all activities related to the use of release liners in batch records or production logs, including liner details, application parameters, and quality control results.
• 4.5.2 Record any deviations from standard procedures and document corrective actions taken to address issues promptly.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QC: Quality Control

6) Documents, if any

Release Liner Specifications
Batch Records
Supplier Certificates

7) Reference, if any

ISO 12625: Release liners for pressure-sensitive adhesive-coated films
ISO 22487: Packaging – Flexible packaging and wrapping materials

8) SOP Version

Version 1.0