Standard Operating Procedure for Personnel Hygiene in Aerosol Production

1) Purpose

The purpose of this SOP is to establish guidelines for maintaining hygiene practices among personnel involved in aerosol production. This ensures that personnel hygiene standards are maintained to prevent contamination of aerosol products and comply with regulatory requirements.

2) Scope

This SOP applies to all personnel working in aerosol production areas at [Company Name], including operators, supervisors, maintenance staff, and visitors.

3) Responsibilities

Production Manager: Ensure compliance with hygiene practices and provide necessary resources.
Quality Assurance (QA) Manager: Monitor and enforce hygiene standards during production.
Human Resources (HR) Department: Ensure that personnel are trained on hygiene practices.
All Personnel: Follow hygiene procedures and report any deviations or concerns.

4) Procedure

4.1 Personal Hygiene Practices:
4.1.1 Wash hands thoroughly with soap and water before entering production areas and after breaks.
4.1.2 Wear clean and appropriate protective clothing, including gowns, gloves, hairnets, and shoe covers.
4.1.3 Remove jewelry, watches, and other accessories that may pose contamination risks.

4.2 Cleanroom Entry Protocol:
4.2.1 Enter cleanrooms through designated entry points and follow gowning procedures.
4.2.2 Ensure that gowning materials are stored and used according to established procedures.
4.2.3 Inspect gowning attire for cleanliness and integrity before entering production areas.

4.3 Personal Health and Behavior:
4.3.1 Report any illnesses, cuts, or skin infections to the supervisor before entering production areas.
4.3.2 Avoid touching the face, hair, or any exposed skin while in production areas.
4.3.3 Follow guidelines for eating, drinking, and smoking in designated areas only.

4.4 Training and Education:
4.4.1 Provide initial and ongoing training on hygiene practices to all personnel.
4.4.2 Conduct periodic refresher training sessions to reinforce hygiene standards.
4.4.3 Document training sessions and maintain records of personnel hygiene competency.

4.5 Hygiene Monitoring and Audits:
4.5.1 Conduct regular audits and inspections of personnel hygiene practices.
4.5.2 Use checklists to assess compliance with hygiene protocols and identify areas for improvement.
4.5.3 Implement corrective actions based on audit findings to maintain hygiene standards.

4.6 Reporting and Documentation:
4.6.1 Encourage personnel to report any breaches of hygiene practices or concerns regarding product contamination.
4.6.2 Document all incidents, deviations, and corrective actions related to personnel hygiene.
4.6.3 Review and update the SOP as needed based on audit results and regulatory changes.

5) Abbreviations, if any

QA: Quality Assurance
HR: Human Resources
SOP: Standard Operating Procedure

6) Documents, if any

Personnel Hygiene Training Records
Hygiene Audit Reports
Incident Reports
Updated SOPs and Work Instructions

7) Reference, if any

GMP Guidelines
ISO 14644: Cleanrooms and Associated Controlled Environments
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing

8) SOP Version

Version 1.0