Standard Operating Procedure for Gowning Procedures for Equipment Handling
1) Purpose
The purpose of this SOP is to establish procedures for gowning requirements and practices when handling equipment used in the manufacturing of dental dosage forms, including pastes, gels, and mouthwashes. Proper gowning procedures minimize contamination risks, maintain product quality, and ensure compliance with regulatory standards.
2) Scope
This SOP applies to all personnel involved in the handling, operation, and maintenance of equipment used in pharmaceutical manufacturing processes for dental dosage forms. It includes gowning procedures for controlled environments to prevent microbial, particulate, or other forms of contamination.
3) Responsibilities
The Quality Assurance (QA) Department is responsible for establishing and enforcing gowning procedures in accordance with regulatory requirements. The Production and Maintenance Departments ensure compliance during equipment handling, operation, and maintenance activities. All personnel are responsible for following these procedures to maintain product integrity and safety.
4) Procedure
4.1 Gowning Requirements
4.1.1 Identify gowning requirements based on the cleanliness classification of the manufacturing area and equipment handling activities.
4.1.2 Select appropriate gowning materials, including gowns, gloves, hair covers, shoe covers, and face masks, based on cleanliness levels and contamination risks.
4.1.3 Ensure gowning materials meet regulatory standards and are compatible with equipment handling requirements.
4.2 Gowning Procedures
4.2.1 Wash hands thoroughly with soap and water before gowning and ensure nails are clean and trimmed to prevent contamination.
4.2.2 Wear clean undergarments and remove jewelry, watches, and personal items that may pose contamination risks.
4.2.3 Put on gowning materials in the following order: shoe covers, hair covers, face masks, gowns, and gloves.
4.2.4 Ensure gowning materials are worn correctly to cover all exposed skin and minimize particle shedding.
4.3 Equipment Handling
4.3.1 Verify equipment cleanliness and integrity before handling to prevent cross-contamination.
4.3.2 Handle equipment with care to avoid physical damage or contamination during transportation, setup, and operation.
4.3.3 Use designated tools or equipment handling aids when moving or manipulating heavy or delicate equipment.
4.4 Gowning Removal
4.4.1 Remove gowning materials in the designated gown removal area or as per facility procedures.
4.4.2 Dispose of single-use gowning materials in designated waste bins or containers according to environmental guidelines.
4.4.3 Wash hands thoroughly after gowning removal to minimize the risk of contamination.
4.5 Documentation and Training
4.5.1 Maintain records of gowning procedures, including gowning logs, training records, and gowning material inventory.
4.5.2 Provide regular training on gowning procedures to personnel involved in equipment handling and manufacturing operations.
5) Abbreviations, if any
SOP – Standard Operating Procedure
QA – Quality Assurance
6) Documents, if any
Gowning Procedure Manual
Gowning Logs
Training Records
Regulatory Guidelines
7) Reference, if any
Good Manufacturing Practices (GMP) guidelines
ISO 14644 Cleanroom Standards
Local regulatory requirements for gowning in pharmaceutical manufacturing
8) SOP Version
Version 1.0