Standard Operating Procedure for Use of Adhesives in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to define procedures for the proper handling, application, and control of adhesives used in the production of transdermal patches.

2) Scope

This SOP applies to the use of adhesives during all stages of transdermal patch production, including formulation, coating, and assembly, within the facility.

3) Responsibilities

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

4) Procedure

4.1 Adhesive Selection and Handling

• 4.1.1 Select adhesives based on formulation requirements, including compatibility with patch materials and intended application characteristics.
• 4.1.2 Store adhesives in controlled conditions (e.g., temperature and humidity) as specified by the manufacturer to maintain stability and performance.

4.2 Adhesive Application

• 4.2.1 Ensure cleanliness of equipment and surfaces used for adhesive application to prevent contamination and ensure uniform coating.
• 4.2.2 Apply adhesives according to validated procedures and batch-specific instructions to achieve desired adhesive properties and coat weight.

4.3 Quality Control Checks

• 4.3.1 Conduct in-process checks to verify adhesive application parameters, such as coat weight, thickness, and uniformity, using appropriate testing methods.
• 4.3.2 Collect samples for further analysis or testing to ensure adhesive performance meets specified criteria.

4.4 Cleaning and Maintenance

• 4.4.1 Clean adhesive application equipment and tools regularly to prevent buildup and ensure consistent performance.
• 4.4.2 Perform preventive maintenance on equipment as per manufacturer recommendations to minimize downtime and ensure reliable operation.

4.5 Documentation and Reporting

• 4.5.1 Document all activities related to adhesive use in batch records or production logs, including adhesive batch 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

Adhesive Specifications
Batch Records
Equipment Maintenance Logs

7) Reference, if any

USP General Chapter 1121: Emulsions and Adhesives
ISO 14644: Cleanrooms and Associated Controlled Environments

8) SOP Version

Version 1.0