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SOP for Energy Control Procedures in Creams Production

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SOP for Energy Control Procedures in Creams Production

Standard Operating Procedure for Energy Control Procedures in Creams Production

1) Purpose

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

2) Scope

This SOP applies to all personnel involved in maintenance, servicing, and production operations in creams production facilities. It covers the procedures for isolating, securing, and verifying energy sources to protect personnel from hazardous energy exposures.

3) Responsibilities

It is the responsibility of all personnel involved in maintenance and production operations to follow these energy control procedures to prevent accidental equipment start-up or release of stored energy. Supervisors are responsible for ensuring compliance and providing necessary training to personnel.

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4) Procedure

4.1 Preparation for Energy Control

4.1.1 Identify the equipment or machinery that requires energy control procedures based on maintenance or servicing requirements.

4.1.2 Notify affected personnel about the planned energy control activities and obtain necessary permits as per company policies.

4.1.3 Conduct a risk assessment to identify potential hazards associated with energy sources and establish appropriate control measures.

4.2 Shutdown and Isolation

4.2.1 Notify production personnel about the planned shutdown and isolation of equipment or machinery.

4.2.2 Turn off or shut down

the equipment using normal operating controls.

4.2.3 Isolate energy sources by locking out or tagging out energy isolation devices, such as switches, valves, or circuit breakers.

4.3 Release of Stored Energy

4.3.1 Verify the isolation of energy sources by attempting to start or operate the equipment using normal controls.

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4.3.2 Relieve, disconnect, or dissipate stored energy (e.g., hydraulic pressure, residual heat) to ensure equipment is safe for maintenance or servicing.

4.3.3 Use appropriate tools and methods to release stored energy safely, following manufacturer’s instructions and safety guidelines.

4.4 Lockout/Tagout Devices

4.4.1 Attach lockout or tagout devices to energy isolation points to prevent accidental energization or startup of equipment.

4.4.2 Ensure only authorized personnel who placed the lockout/tagout devices are permitted to remove them after completing the maintenance or servicing activities.

4.4.3 Maintain control of lockout/tagout devices and keys throughout the duration of the maintenance or servicing work.

4.5 Verification and Testing

4.5.1 Verify the effectiveness of energy control procedures by testing equipment controls to ensure they do not activate equipment.

4.5.2 Conduct periodic inspections and audits to review the integrity of lockout/tagout devices and compliance with energy control procedures.

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4.5.3 Record details of energy control activities, including equipment shutdown, isolation, release of stored energy, and removal of lockout/tagout devices, in the appropriate log or checklist.

4.6 Restoration of Equipment

4.6.1 Notify production personnel when maintenance or servicing activities are completed and equipment is ready for restoration to normal operation.

4.6.2 Remove lockout/tagout devices only after ensuring all tools and personnel are clear from the equipment.

4.6.3 Gradually restore energy sources and verify equipment operation to confirm functionality and safety.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Energy Control Permit

Lockout/Tagout Procedures

Risk Assessment Report

7) Reference, if any

OSHA (Occupational Safety and Health Administration) Control of Hazardous Energy (Lockout/Tagout) Standard (29 CFR 1910.147)

Company-specific Energy Control Program

8) SOP Version

Version 1.0

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Standard Operating Procedures V 1.0

  • Aerosols
  • Analytical Method Development
  • Bioequivalence Bioavailability Study
  • Capsule Formulation
  • Clinical Studies
  • Creams
  • Data Integrity
  • Dental Dosage Forms
  • Drug Discovery
  • Environment, Health and Safety
  • Formulation Development
  • Gels
  • Good Distribution Practice
  • Good Warehousing Practices
  • In-Process Control
  • Injectables
  • Liquid Orals
  • Liposome and Emulsion Formulations
  • Lotions
  • Lyophilized Products
  • Maintenance Dept.
  • Medical Devices
  • Metered-Dose Inhaler
  • Microbiology Testing
  • Nanoparticle Formulation
  • Nasal Spray Formulations
  • Nebulizers
  • Ocular (Eye) Dosage Forms
  • Ointments
  • Otic (Ear) Dosage Forms
  • Pharmacovigilance
  • Powder & Granules
  • Purchase Departments
  • Quality Assurance
  • Quality Control
  • Raw Material Stores
  • Regulatory Affairs
  • Tablet Manufacturing
  • Rectal Dosage Forms
  • Transdermal Patches
  • Vaginal Dosage Forms
  • Validations and Qualifications

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NEW! Revised SOPs – V 2.0

  • Aerosols V 2.0
  • Analytical Method Development V 2.0
  • API Manufacturing V 2.0
  • BA-BE Studies V 2.0
  • Biosimilars V 2.0
  • Capsules V 2.0
  • Creams V 2.0
  • Elixers V 2.0
  • Ointments V 2.0
  • Raw Material Warehouse V 2.0
  • Tablet Manufacturing V2.0

New Publication: A must for All.

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