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 devices to ensure that energy sources are de-energized and cannot be restarted inadvertently.
• 4.3.2 Confirm that stored energy (e.g., capacitors, springs) has been safely discharged or blocked to prevent unexpected movement or activation.

4.4 Work Performed Under LOTO

• 4.4.1 Perform maintenance, repairs, adjustments, or servicing only after ensuring that all energy sources are effectively controlled and isolated under lockout/tagout procedures.
• 4.4.2 Use specified personal protective equipment (PPE) and follow safe work practices outlined in associated work instructions or procedures.

4.5 Removal of Lockout/Tagout Devices

• 4.5.1 Remove lockout/tagout devices only after completing work, verifying equipment integrity, and ensuring that all personnel are clear of danger zones.
• 4.5.2 Conduct a final inspection to confirm that equipment is operational and safe for normal production activities.

5) Abbreviations, if any

SOP: Standard Operating Procedure
LOTO: Lockout/Tagout
PPE: Personal Protective Equipment

6) Documents, if any

Energy Control Program
Lockout/Tagout Procedures
Risk Assessment Reports

7) Reference, if any

OSHA 29 CFR 1910.147: Control of hazardous energy (lockout/tagout)
NFPA 70E: Standard for electrical safety in the workplace

8) SOP Version

Version 1.0