Personnel Hygiene Procedures in MDI Production
1) Purpose
The purpose of this SOP is to establish procedures for maintaining personnel hygiene standards in metered-dose inhaler (MDI) production to prevent contamination and ensure product quality.
2) Scope
This SOP applies to all personnel working in MDI production areas, including production operators, technicians, and support staff.
3) Responsibilities
The responsibilities for this SOP include adhering to hygiene practices, maintaining cleanliness, and reporting any deviations or concerns to supervisors.
4) Procedure
4.1 Personal Cleanliness
4.1.1 Wash hands thoroughly with soap and water before entering production areas.
4.1.2 Wear clean, designated uniforms or protective clothing, including hairnets, beard covers, and gloves as required.
4.2 Hygiene Practices
4.2.1 Avoid touching face, hair, or any exposed skin while working in production areas.
4.2.2 Follow proper respiratory hygiene, including covering nose and mouth when coughing or sneezing.
4.3 Health Monitoring
4.3.1 Report any illnesses, symptoms, or health conditions to supervisors immediately.
4.3.2 Undergo periodic health checks as required by company policy.
4.4 Cleanliness of Production Areas
4.4.1 Keep workstations clean and organized during production activities.
4.4.2 Dispose of waste and used materials in designated bins according to procedures.
4.5 Training and Awareness
4.5.1 Attend training sessions on hygiene practices and infection control.
4.5.2 Stay informed about updates to hygiene protocols and procedures.
5)
MDI: Metered-Dose Inhaler
SOP: Standard Operating Procedure
6) Documents, if any
Hygiene protocol documents, training records, and health check reports should be maintained.
7) Reference, if any
Refer to hygiene guidelines from regulatory bodies such as FDA, EMA, and local health authorities.
8) SOP Version
Version 1.0
