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 |