SOP for Clean Room Entry and Exit Procedures

Standard Operating Procedure for Clean Room Entry and Exit Procedures

1) Purpose

This SOP provides guidelines for personnel entering and exiting cleanroom environments to minimize contamination risks in manufacturing areas, ensuring adherence to GMP (Good Manufacturing Practices) standards.

2) Scope

This SOP applies to all personnel and visitors entering or exiting cleanrooms within GMP-regulated facilities at [Company Name].

3) Responsibilities

All Employees: Ensure full compliance with the entry and exit procedures for cleanrooms.
Supervisors: Responsible for monitoring employee adherence and training personnel on cleanroom protocols.

4) Procedure

4.1 Entry Procedures

4.1.1 Preparation Before Entry

Remove all jewelry, personal items, and cosmetics that could cause contamination. This includes watches, rings, and bracelets.
Wash hands thoroughly with soap and water, followed by hand sanitization using an alcohol-based solution at designated hygiene stations.

4.1.2 Donning Cleanroom Garments

Enter the gowning area in the prescribed order: hairnet, facemask, cleanroom gown, shoe covers, and gloves. Ensure the garments are of the correct size and are GMP-approved for cleanroom use.
Put on sterile gloves and inspect for tears or contamination. Change gloves as necessary.

4.1.3 Entering the Cleanroom

Upon completion of gowning, pass through the airlock or change room while ensuring doors are not opened simultaneously, as this can disrupt the cleanroom’s positive pressure.
Upon entry, sanitize gloved hands using the appropriate disinfectant before touching any equipment or materials.

4.2 Exit Procedures

4.2.1 Removal of Cleanroom Garments

Remove gloves, facemasks, and gowns in the correct sequence within the change room. Dispose of single-use items in designated bins.
Shoe covers must be removed last and disposed of in appropriate waste containers to avoid cross-contamination outside the cleanroom.

4.2.2 Exiting the Cleanroom

Pass through the airlock or change room. Do not open both doors simultaneously, and ensure that the cleanroom remains positively pressurized.
Once outside the cleanroom, wash hands thoroughly and report any contamination incidents to the supervisor immediately.

4.3 Monitoring and Compliance

4.3.1 Routine Monitoring

Supervisors must conduct regular inspections of cleanroom entry and exit practices to ensure compliance with GMP guidelines.
All deviations from the SOP must be recorded in the deviation log and reported to Quality Assurance (QA) for further action.

4.3.2 Training

All personnel must receive cleanroom training, which includes proper gowning and entry/exit procedures. Refresher training must be conducted every six months.
Training records must be maintained in the employee training log and be readily available for audit purposes.

5) Abbreviations, if any

GMP: Good Manufacturing Practices
QA: Quality Assurance

6) Documents, if any

Deviation Log
Employee Training Log

7) References, if any

ISO 14644: Cleanroom Standards
Internal SOP for cleanroom gowning and hygiene

8) SOP Version

Version 1.0

Annexure

1. Cleanroom Entry/Exit Log Template


  
    Date
    Employee ID
    Entry Time
    Exit Time
    Supervisor Initials
    QA Approval
  
  
    DD/MM/YYYY
    Employee ID
    Time Entered
    Time Exited
    Supervisor Name
    QA Name

Date	Employee ID	Entry Time	Exit Time	Supervisor Initials	QA Approval
DD/MM/YYYY	Employee ID	Time Entered	Time Exited	Supervisor Name	QA Name