Standard Operating Procedure for Energy Control Procedures in Transdermal Patches Production

1) Purpose

The purpose of this SOP is to establish procedures for the control of energy sources during maintenance and servicing activities in transdermal patch production to prevent accidents and ensure worker safety.

2) Scope

This SOP applies to all energy sources, including electrical, mechanical, hydraulic, pneumatic, and potential energy stored in equipment, machinery, or systems used in transdermal patch production.

3) Responsibilities

The Maintenance and Production Departments are jointly responsible for implementing and following this SOP. Authorized personnel are responsible for energy control during maintenance.

4) Procedure

4.1 Energy Control Program

• 4.1.1 Develop and maintain an energy control program outlining procedures for the isolation, de-energization, and verification of energy sources during maintenance or servicing.
• 4.1.2 Designate authorized employees responsible for implementing and overseeing energy control procedures as per established roles and responsibilities.

4.2 Lockout/Tagout (LOTO) Procedures

• 4.2.1 Prior to performing maintenance or service, conduct a risk assessment to identify energy sources that need to be isolated or controlled using lockout/tagout devices.
• 4.2.2 Apply lockout/tagout devices to energy isolation points to prevent accidental activation or release of stored energy.

4.3 Verification of Energy Isolation

• 4.3.1 Verify the effectiveness of energy isolation by testing equipment controls or