Standard Operating Procedure for Personal Protective Equipment (PPE) for Equipment Operation
1) Purpose
The purpose of this SOP is to define the procedures for selecting, wearing, and maintaining personal protective equipment (PPE) when operating equipment used in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. Proper use of PPE enhances safety, minimizes occupational hazards, and complies with regulatory requirements.
2) Scope
This SOP applies to all personnel involved in equipment operation, maintenance, and troubleshooting within pharmaceutical manufacturing facilities. It includes guidelines for selecting appropriate PPE based on equipment hazards, operational risks, and regulatory standards.
3) Responsibilities
The Safety and Health Department is responsible for developing and implementing PPE protocols. The Engineering and Maintenance Departments ensure PPE availability and functionality. Production personnel are responsible for wearing PPE according to established procedures to protect themselves and others from workplace hazards.
4) Procedure
4.1 PPE Selection
4.1.1 Conduct a hazard assessment to identify potential risks associated with equipment operation, such as chemical exposure, physical hazards, and biological contaminants.
4.1.2 Select appropriate PPE based on hazard assessment results, including gloves, safety glasses, face shields, protective clothing, hearing protection, and respiratory protection.
4.1.3 Ensure selected PPE meets regulatory standards and manufacturer specifications for compatibility with
4.2 PPE Inspection and Maintenance
4.2.1 Inspect PPE before each use to ensure integrity, cleanliness, and functionality.
4.2.2 Replace damaged or worn-out PPE immediately and dispose of unusable items according to facility procedures.
4.2.3 Store PPE in designated areas when not in use to prevent contamination or damage.
4.3 PPE Donning and Doffing
4.3.1 Wash hands thoroughly before handling PPE to prevent contamination.
4.3.2 Don PPE in the following order: protective clothing, gloves, safety glasses or face shields, respiratory protection (if required), and any additional PPE as per hazard assessment.
4.3.3 Adjust and secure PPE to ensure a proper fit and full coverage of exposed skin areas.
4.3.4 Remove PPE carefully to avoid self-contamination, following established doffing procedures.
4.4 PPE Use During Equipment Operation
4.4.1 Wear appropriate PPE continuously during equipment setup, operation, maintenance, and cleaning activities.
4.4.2 Replace gloves and other disposable PPE items as needed during prolonged operations or when contaminated.
4.4.3 Maintain clear communication and situational awareness while wearing PPE to ensure operational safety and efficiency.
4.5 PPE Training and Documentation
4.5.1 Provide training to personnel on the proper selection, use, and maintenance of PPE based on job responsibilities and identified hazards.
4.5.2 Document PPE training sessions, including attendance records and competency assessments.
4.5.3 Review and update PPE procedures periodically to incorporate new hazards, PPE technologies, and regulatory changes.
5) Abbreviations, if any
SOP – Standard Operating Procedure
PPE – Personal Protective Equipment
6) Documents, if any
Hazard Assessment Report
PPE Inventory Records
Training Records
Regulatory Guidelines
7) Reference, if any
Occupational Safety and Health Administration (OSHA) regulations
National Institute for Occupational Safety and Health (NIOSH) guidelines
Manufacturer’s instructions for PPE use and maintenance
8) SOP Version
Version 1.0